Clinical trial NCT02941926: Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
Official title: COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: HR-positive HER2-negative
advanced breast cancer
LEE011
ribociclib
letrozole
goserelin
CDK
CDK4
CDK6
CDK4/6
Phase IIIb
ER-positive
PR-positive
premenopausal
postmenopausal
men with advanced breast cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-10-21
Enrollment: 3246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..

Detailed description: This was an open-label, single arm, multi-center Phase IIIb study. The study was composed of 2 phases: Core Phase and Extension Phase. In the Core Phase, safety and efficacy data was collected. The study treatment during the Core Phase was provided until disease progression, death, unacceptable toxicities, physician's decision, subject/guardian's decision, protocol deviation, study termination by sponsor, lost to follow-up, technical problems or up to 18 months after LPFV.

In the event that patients were still deriving benefit at the end of the Core phase and ribociclib was not approved or available and reimbursed, patients were transitioned to the Extension Phase and continued to receive study treatment until progression, intolerance, death or physician/patient decision. Only safety and clinical benefit (as assessed by investigator) data was collected in the Extension Phase. During the Extension Phase, if ribociclib became locally approved and reimbursed, patients were to be transitioned to prescription. Patients who completed the Extension Phase and continued to derive clinical benefit from the treatment based on the investigator's evaluation received ribociclib from prescription (if approved and reimbursed), another post-trial access program, or other drug access/support program(s).

Canadian sub-study: this sub-study was a multicenter Canadian exploratory correlative sample collection sub-study that aimed to better understand mechanisms of response and resistance to ribociclib in combination with letrozole therapy. This sub-study was available for all Canadian subjects enrolled on the main study and did not alter the planned treatment.

Eligibility criteria: Key Inclusion Criteria:

* Male or female advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
* In the case of women, both pre/perimenopausal and postmenopausal patients were allowed to be included in this study; menopausal status was relevant for the requirement of goserelin to be used concomitantly with ribociclib and letrozole.

  1. Postmenopausal status was defined either by: I).Prior bilateral oophorectomy OR ii). Age ≥ 60 OR iii). Age \< 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range. If patient was taking tamoxifen or toremifene and age \< 60, then FSH and plasma estradiol levels would be in post-menopausal range per local normal range (NCCN Guidelines version 2.2017).

     Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol were needed to ensure menopausal status.
  2. Premenopausal status was defined as either: I).Patient had last menstrual period within the last 12 months OR ii). If on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range OR iii). In case of therapy induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal range per local normal range.
  3. Perimenopausal status was define as neither premenopausal nor postmenopausal
* Patient had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
* Patient had HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test was required by local laboratory testing.
* Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Patient had adequate bone marrow and organ function as defined by ALL of the following laboratory values (as assessed by local laboratory):

  * Absolute neutrophil count ≥ 1.5 × 10\^9/L
  * Platelets ≥ 100 × 10\^9/L
  * Hemoglobin ≥ 9.0 g/dL
  * Potassium, sodium, calcium corrected for serum albumin and magnesium within normal limits or corrected to within normal limits with supplements before first dose of the study medication
  * INR ≤1.5
  * Serum creatinine \<1.5 mg/dl or creatinine clearance≥50 mL/min
  * In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 × ULN. If the patient had liver metastases, ALT and AST should be \< 5 × ULN.
  * Total serum bilirubin \< ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with well-documented Gilbert's Syndrome
* Patient must have had a 12-lead ECG with ALL of the following parameters at screening:

  * QTcF interval at screening \<450 msec (using Fridericia's correction)
  * Resting heart rate ≥ 50 bpm

Key Exclusion Criteria:

* Patient who received any CDK4/6 inhibitor
* Patient who received any prior systemic hormonal therapy for advanced breast cancer; no more than one prior regimen of chemotherapy for the treatment of metastatic disease was permitted. Note:

  * Patients who received (neo) adjuvant therapy for breast cancer were eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval had to be greater than 12 months from the completion of treatment until study entry.
  * Patients who received ≤ 28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial were eligible.
  * Any prior (neo) adjuvant anti-cancer therapy or prior chemotherapy for metastatic disease had to be stopped at least 5 half-lives or 7 days, whichever was longer, before study inclusion.
* Patient was concurrently using other anti-cancer therapy.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) During Treatment With Ribociclib + Letrozole in the Core Phase
timeFrame: From start of treatment up to 30 days after last treatment (for participants who did not enter to the Extension phase) or up to last treatment in the Core phase (for participants who entered the Extension phase), assessed up to approximately 33 months.
Secondary outcomes:
measure: Time-to-Progression (TTP) Based on Investigator's Assessment (Core Phase)
timeFrame: Up to approximately 33 months
measure: Overall Response Rate (ORR) Based on Investigator's Assessment (Core Phase)
timeFrame: Up to approximately 33 months
measure: Clinical Benefit Rate (CBR) Based on Investigator's Assessment (Core Phase)
timeFrame: Up to approximately 33 months
measure: Change From Baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) Score (Core Phase)
timeFrame: On Day 1 of Cycle 1, 2, 3, 4 ,5, 6, 8, 10, 12 and after that every 3 cycles, and End of treatment, assessed up to 33 months. Cycle=28 days
measure: Number of Participants With AEs and SAEs in the Extension Phase
timeFrame: From first dose of treatment in the Extension phase up to 30 days after last dose of treatment, assessed up approximately 37.6 months
measure: Number of Participants With Clinical Benefit (Extension Phase)
timeFrame: On Day 1 of every 3 cycles, starting from Cycle 1 of the Extension phase until end of treatment, assessed up to 37.4 months. Cycle= 28 days
Other outcomes:
measure: Canadian Sub-study: Proteomic Analysis of Ribociclib and Letrozole Cohort Not Achieving Clinical Benefit Compared to a Cohort Sensitive to Treatment With Ribociclib and Letrozole
timeFrame: Screening (up to 28 days before first dose of study treatment)
Locations:
city: Anchorage
country: United States
facility: Alaska Cancer Research and Education Center
state: Alaska
city: Chandler
country: United States
facility: Ironwood Cancer and Research Centers
state: Arizona
city: Phoenix
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates Arizona Oncology Assoc. (2)
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group SC
state: California
city: Los Angeles
country: United States
facility: USC Norris Cancer Center
state: California
city: Orange
country: United States
facility: University of California Irvine UC Irvine (11)
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology and Oncology
state: California
city: Pismo Beach
country: United States
facility: PCR Oncology
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center Onc Dept
state: California
city: Denver
country: United States
facility: Centura Health Research Center Centura Health Research Center
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Hospital Poudre Valley Health System
state: Colorado
city: Glenwood Springs
country: United States
facility: Valley View Hospital Cancer Center
state: Colorado
city: Davie
country: United States
facility: Florida Cancer Research Institute Dept of Oncology
state: Florida
city: Hollywood
country: United States
facility: Foundation for Sickle Cell Disease Research
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center for Research 1730 Location
state: Florida
city: Orange
country: United States
facility: Mid Florida Hematology and Onc Ctr
state: Florida
city: Savannah
country: United States
facility: Summit Cancer Care Summit Cancer Care (SC)
state: Georgia
city: Thomasville
country: United States
facility: John D Archbold Memorial Hospital John D. Archbold Mem Hosp (4)
state: Georgia
city: Boise
country: United States
facility: Saint Alphonsus Regional Medical Center
state: Idaho
city: Chicago
country: United States
facility: Stroger Cook County Hospital Division of Hematology & Onc
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates Presence Cancer Center
state: Illinois
city: Normal
country: United States
facility: Mid Illinois Hematology Oncology Mid Illinois Hema/Onc (3)
state: Illinois
city: Tinley Park
country: United States
facility: Alpha Med Physician Group, LLC
state: Illinois
city: Goshen
country: United States
facility: Indian Univ Health Goshen Center forCancer SC
state: Indiana
city: Munster
country: United States
facility: Northwest Oncology
state: Indiana
city: Sioux City
country: United States
facility: June E. Nylan Cancer Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center University of Kansas Med Ctr 9
state: Kansas
city: Overland Park
country: United States
facility: Sarah Cannon at Overland Park Regional Medical Center
state: Kansas
city: New Orleans
country: United States
facility: John Ochsner Heart and Vascular Institute Clinical Trials
state: Louisiana
city: Portland
country: United States
facility: Northern Light Mercy Hospital SC
state: Maine
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center Cancer Center Greater Baltimore Medical Ctr
state: Maryland
city: Rockville
country: United States
facility: Maryland Oncology Hematology P A Columbia
state: Maryland
city: Rockville
country: United States
facility: Kaiser Permanente
state: Maryland
city: Washington DC
country: United States
facility: Medical Faculty Assc Inc Medical Faculty Assc., Inc. (2
state: Maryland
city: Jackson
country: United States
facility: Jackson Oncology Associates
state: Mississippi
city: Lincoln
country: United States
facility: Nebraska Hematology-Oncology, P.C.
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Cancer Specialists Oncology Hematology West
state: Nebraska
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)
state: Nevada
city: Elizabeth
country: United States
facility: Trinitas Comprehensive Cancer Center
state: New Jersey
city: Englewood
country: United States
facility: Englewood Health
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital / Luckow Pavillion
state: New Jersey
city: Somerset
country: United States
facility: Somerset Hematology Oncology Associates Somerset Hematolgy Onc -MI
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Cancer Care Alliance .
state: New Mexico
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Bronx
country: United States
facility: Eastchester Center for Cancer Care
state: New York
city: Lake Success
country: United States
facility: Clinical Research Alliance
state: New York
city: Charlotte
country: United States
facility: Oncology Speciialists of Charlotte
state: North Carolina
city: Canton
country: United States
facility: Aultman Cancer Center Main Centre
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital Cancer Center Research Program Linder Research Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Seidman Cancer Center Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation Cleveland Clinic (5)
state: Ohio
city: Kettering
country: United States
facility: Dayton Physicians
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute SC-2
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health Sciences University SC-5
state: Oregon
city: Florence
country: United States
facility: McLeod Center for Cancer Treatment and Research
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Millennium Research Clin Develop Millennium Oncology - FL
state: Texas
city: San Antonio
country: United States
facility: Mays Cancer Ctr Uthsa Mdacc
state: Texas
city: Tyler
country: United States
facility: Hope Cancer Center of East Texas
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Bellingham
country: United States
facility: PeaceHealth St Joseph Medical Center
state: Washington
city: Everett
country: United States
facility: Providence Regional Medical Centre of Everett
state: Washington
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and Onco
state: Washington
city: Renton
country: United States
facility: Valley Medical Center Research Valley Medical Center
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center-Oncology SC
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties Dept.ofNW Med. Specialties
state: Washington
city: Milwaukee
country: United States
facility: Columbia St Mary s Hospital of Milwaukee St. Mary's Hospital Ozaukee
state: Wisconsin
city: Cheyenne
country: United States
facility: Cheyenne Regional Medical Center Cheyenne Regional Med Ctr (3)
state: Wyoming
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: San Miguel De Tucuman
country: Argentina
facility: Novartis Investigative Site
state: Tucuman
city: La Rioja
country: Argentina
facility: Novartis Investigative Site
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
state: Tyrol
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Leoben
country: Austria
facility: Novartis Investigative Site
city: Rankweil
country: Austria
facility: Novartis Investigative Site
city: Salzburg
country: Austria
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Sint Niklaas
country: Belgium
facility: Novartis Investigative Site
state: Oost Vlaanderen
city: Antwerp
country: Belgium
facility: Novartis Investigative Site
city: Bonheiden
country: Belgium
facility: Novartis Investigative Site
city: Brugge
country: Belgium
facility: Novartis Investigative Site
city: Brussels
country: Belgium
facility: Novartis Investigative Site
city: Brussel
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Charleroi
country: Belgium
facility: Novartis Investigative Site
city: Genk
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Hasselt
country: Belgium
facility: Novartis Investigative Site
city: Kortrijk
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Luxembourg
country: Belgium
facility: Novartis Investigative Site
city: Mons
country: Belgium
facility: Novartis Investigative Site
city: Namur
country: Belgium
facility: Novartis Investigative Site
city: Roeselare
country: Belgium
facility: Novartis Investigative Site
city: Verviers
country: Belgium
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
city: Gabrovo
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Kelowna
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Surrey
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Novartis Investigative Site
state: Manitoba
city: Moncton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Cambridge
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Kingston
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Kitchener
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Newmarket
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: North York
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Oshawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Sault Ste Marie
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Sudbury
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Laval
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Regina
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Santiago
country: Chile
facility: Novartis Investigative Site
city: Brno
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Liberec
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Prague 8
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Zlin
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Hradec Kralove
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: Olomouc
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: Brno
country: Czechia
facility: Novartis Investigative Site
city: Ceske Budejovice
country: Czechia
facility: Novartis Investigative Site
city: Pardubice
country: Czechia
facility: Novartis Investigative Site
city: Prague 5
country: Czechia
facility: Novartis Investigative Site
city: Praha 10
country: Czechia
facility: Novartis Investigative Site
city: Praha 4
country: Czechia
facility: Novartis Investigative Site
city: Praha
country: Czechia
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Vejle
country: Denmark
facility: Novartis Investigative Site
city: Helsinki
country: Finland
facility: Novartis Investigative Site
city: Oulu
country: Finland
facility: Novartis Investigative Site
city: Tampere
country: Finland
facility: Novartis Investigative Site
city: Nice Cedex 2
country: France
facility: Novartis Investigative Site
state: Alpes Maritimes
city: Dijon
country: France
facility: Novartis Investigative Site
state: Cote D Or
city: Limoges
country: France
facility: Novartis Investigative Site
state: Haute Vienne
city: Saint-Cloud
country: France
facility: Novartis Investigative Site
state: Hauts De Seine
city: Tours 9
country: France
facility: Novartis Investigative Site
state: Indre Et Loire
city: Reims
country: France
facility: Novartis Investigative Site
state: Marne
city: Albi
country: France
facility: Novartis Investigative Site
city: Angers Cedex 02
country: France
facility: Novartis Investigative Site
city: Avignon
country: France
facility: Novartis Investigative Site
city: Besancon Cedex
country: France
facility: Novartis Investigative Site
city: Bobigny Cedex
country: France
facility: Novartis Investigative Site
city: Bordeaux Cedex
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Caen
country: France
facility: Novartis Investigative Site
city: Clermont-Ferrand
country: France
facility: Novartis Investigative Site
city: Colmar Cedex
country: France
facility: Novartis Investigative Site
city: Corbeil Essonnes
country: France
facility: Novartis Investigative Site
city: Creteil
country: France
facility: Novartis Investigative Site
city: Le Mans Cedex
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Limoges
country: France
facility: Novartis Investigative Site
city: Lyon Cedex 08
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Mont de Marsan cedex
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Nancy
country: France
facility: Novartis Investigative Site
city: Nantes Cedex
country: France
facility: Novartis Investigative Site
city: Paris 10
country: France
facility: Novartis Investigative Site
city: Paris 13
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Perigueux Cedex
country: France
facility: Novartis Investigative Site
city: Pierre Benite
country: France
facility: Novartis Investigative Site
city: Plerin Sur Mer
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Saint Herblain
country: France
facility: Novartis Investigative Site
city: Strasbourg Cedex
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Toulon La Seyne Sur Mer
country: France
facility: Novartis Investigative Site
city: Troyes
country: France
facility: Novartis Investigative Site
city: Vandoeuvre-les-Nancy
country: France
facility: Novartis Investigative Site
city: Ioannina
country: Greece
facility: Novartis Investigative Site
state: GR
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Patras
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Kowloon
country: Hong Kong
facility: Novartis Investigative Site
city: Pokfulam
country: Hong Kong
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: Tamil Nadu
country: India
facility: Novartis Investigative Site
state: Chennai
city: New Delhi
country: India
facility: Novartis Investigative Site
state: Delhi
city: Admedabad
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Nashik
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Jaipur
country: India
facility: Novartis Investigative Site
state: Rajasthan
city: Vellore
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Kolkata
country: India
facility: Novartis Investigative Site
state: West Bengal
city: Delhi
country: India
facility: Novartis Investigative Site
city: Beer-Sheva
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
city: Alessandria
country: Italy
facility: Novartis Investigative Site
state: AL
city: Ancona
country: Italy
facility: Novartis Investigative Site
state: AN
city: L'Aquila
country: Italy
facility: Novartis Investigative Site
state: AQ
city: Arezzo
country: Italy
facility: Novartis Investigative Site
state: AR
city: Asti
country: Italy
facility: Novartis Investigative Site
state: AT
city: Avellino
country: Italy
facility: Novartis Investigative Site
state: AV
city: Bari
country: Italy
facility: Novartis Investigative Site
state: BA
city: Bergamo
country: Italy
facility: Novartis Investigative Site
state: BG
city: Treviglio
country: Italy
facility: Novartis Investigative Site
state: BG
city: Benevento
country: Italy
facility: Novartis Investigative Site
state: BN
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: BO
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: BO
city: Brindisi
country: Italy
facility: Novartis Investigative Site
state: BR
city: Brescia
country: Italy
facility: Novartis Investigative Site
state: BS
city: Brescia
country: Italy
facility: Novartis Investigative Site
state: BS
city: Monserrato
country: Italy
facility: Novartis Investigative Site
state: CA
city: Cuneo
country: Italy
facility: Novartis Investigative Site
state: CN
city: Cremona
country: Italy
facility: Novartis Investigative Site
state: CR
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Cona
country: Italy
facility: Novartis Investigative Site
state: FE
city: San Giovanni Rotondo
country: Italy
facility: Novartis Investigative Site
state: FG
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Grosseto
country: Italy
facility: Novartis Investigative Site
state: GR
city: Lecco
country: Italy
facility: Novartis Investigative Site
state: LC
city: Livorno
country: Italy
facility: Novartis Investigative Site
state: LI
city: Lucca
country: Italy
facility: Novartis Investigative Site
state: LU
city: Monza
country: Italy
facility: Novartis Investigative Site
state: MB
city: Macerata
country: Italy
facility: Novartis Investigative Site
state: MC
city: Messina
country: Italy
facility: Novartis Investigative Site
state: ME
city: Taormina
country: Italy
facility: Novartis Investigative Site
state: ME
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Rozzano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Modena
country: Italy
facility: Novartis Investigative Site
state: MO
city: Nuoro
country: Italy
facility: Novartis Investigative Site
state: NU
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Aviano
country: Italy
facility: Novartis Investigative Site
state: PN
city: Prato
country: Italy
facility: Novartis Investigative Site
state: PO
city: Parma
country: Italy
facility: Novartis Investigative Site
state: PR
city: Fano
country: Italy
facility: Novartis Investigative Site
state: PU
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Reggio Calabria
country: Italy
facility: Novartis Investigative Site
state: RC
city: Reggio Emilia
country: Italy
facility: Novartis Investigative Site
state: RE
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Salerno
country: Italy
facility: Novartis Investigative Site
state: SA
city: Siena
country: Italy
facility: Novartis Investigative Site
state: SI
city: Sassari
country: Italy
facility: Novartis Investigative Site
state: SS
city: Savona
country: Italy
facility: Novartis Investigative Site
state: SV
city: Trento
country: Italy
facility: Novartis Investigative Site
state: TN
city: Candiolo
country: Italy
facility: Novartis Investigative Site
state: TO
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Terni
country: Italy
facility: Novartis Investigative Site
state: TR
city: Udine
country: Italy
facility: Novartis Investigative Site
state: UD
city: Saronno
country: Italy
facility: Novartis Investigative Site
state: VA
city: Mirano
country: Italy
facility: Novartis Investigative Site
state: VE
city: Negrar
country: Italy
facility: Novartis Investigative Site
state: VR
city: Verona
country: Italy
facility: Novartis Investigative Site
state: VR
city: Viterbo
country: Italy
facility: Novartis Investigative Site
state: VT
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Novara
country: Italy
facility: Novartis Investigative Site
city: Amman
country: Jordan
facility: Novartis Investigative Site
city: Ashrafieh
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Saida
country: Lebanon
facility: Novartis Investigative Site
city: Tanjong Bungah
country: Malaysia
facility: Novartis Investigative Site
state: Penang
city: Petaling Jaya
country: Malaysia
facility: Novartis Investigative Site
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
state: Wilayah Persekutuan
city: Putrajaya
country: Malaysia
facility: Novartis Investigative Site
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Monterrey
country: Mexico
facility: Novartis Investigative Site
state: Nuevo Leon
city: Ciudad de Mexico
country: Mexico
facility: Novartis Investigative Site
city: Mexico City
country: Mexico
facility: Novartis Investigative Site
city: Maastricht
country: Netherlands
facility: Novartis Investigative Site
state: AZ
city: Venray
country: Netherlands
facility: Novartis Investigative Site
state: CE
city: Apeldoorn
country: Netherlands
facility: Novartis Investigative Site
state: DZ
city: Arnhem
country: Netherlands
facility: Novartis Investigative Site
state: Gelderland
city: Beverwijk
country: Netherlands
facility: Novartis Investigative Site
city: Breda
country: Netherlands
facility: Novartis Investigative Site
city: Delft
country: Netherlands
facility: Novartis Investigative Site
city: Den Bosch
country: Netherlands
facility: Novartis Investigative Site
city: Den Haag
country: Netherlands
facility: Novartis Investigative Site
city: Dordrecht
country: Netherlands
facility: Novartis Investigative Site
city: Ede
country: Netherlands
facility: Novartis Investigative Site
city: Eindhoven
country: Netherlands
facility: Novartis Investigative Site
city: Enschede
country: Netherlands
facility: Novartis Investigative Site
city: Goes
country: Netherlands
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Hilversum
country: Netherlands
facility: Novartis Investigative Site
city: Hoofddorp
country: Netherlands
facility: Novartis Investigative Site
city: Leeuwarden
country: Netherlands
facility: Novartis Investigative Site
city: Roermond
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Sittard-Geleen
country: Netherlands
facility: Novartis Investigative Site
city: Utrecht
country: Netherlands
facility: Novartis Investigative Site
city: Zutphen
country: Netherlands
facility: Novartis Investigative Site
city: Zwolle
country: Netherlands
facility: Novartis Investigative Site
city: Gralum
country: Norway
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Stavanger
country: Norway
facility: Novartis Investigative Site
city: Muscat
country: Oman
facility: Novartis Investigative Site
city: Panama City
country: Panama
facility: Novartis Investigative Site
city: Taguig City
country: Philippines
facility: Novartis Investigative Site
state: Metro Manila
city: Las Pinas
country: Philippines
facility: Novartis Investigative Site
city: San Juan City
country: Philippines
facility: Novartis Investigative Site
city: Zory
country: Poland
facility: Novartis Investigative Site
state: Slaskie
city: Bydgoszcz
country: Poland
facility: Novartis Investigative Site
city: Bytom
country: Poland
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Lublin
country: Poland
facility: Novartis Investigative Site
city: Opole
country: Poland
facility: Novartis Investigative Site
city: Rzeszow
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Braga
country: Portugal
facility: Novartis Investigative Site
city: Guimaraes
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Leningrad Region
country: Russian Federation
facility: Novartis Investigative Site
state: Russia
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
state: Tatarstan Republic
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Irkutsk
country: Russian Federation
facility: Novartis Investigative Site
city: Kaluga
country: Russian Federation
facility: Novartis Investigative Site
city: Krasnoyarsk
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow Region Istra Village
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow Rerion Balashiha
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov-na-Donu
country: Russian Federation
facility: Novartis Investigative Site
city: Samara
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Ufa
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Dammam
country: Saudi Arabia
facility: Novartis Investigative Site
city: Makkah
country: Saudi Arabia
facility: Novartis Investigative Site
city: Riyadh
country: Saudi Arabia
facility: Novartis Investigative Site
city: Riyadh
country: Saudi Arabia
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Poprad
country: Slovakia
facility: Novartis Investigative Site
city: Ljubljana
country: Slovenia
facility: Novartis Investigative Site
city: Maribor
country: Slovenia
facility: Novartis Investigative Site
city: Elche
country: Spain
facility: Novartis Investigative Site
state: Alicante
city: Almeria
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Granada
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Huelva
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Jaen
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sabadell
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Jerez
country: Spain
facility: Novartis Investigative Site
state: Cadiz
city: Toledo
country: Spain
facility: Novartis Investigative Site
state: Castilla La Mancha
city: Salamanca
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Lerida
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Badalona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Girona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Hospitalet de LLobregat
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Castellon
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Badajoz
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: Caceres
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Palma De Mallorca
country: Spain
facility: Novartis Investigative Site
state: Islas Baleares
city: Las Palmas De Gran Canarias
country: Spain
facility: Novartis Investigative Site
state: Las Palmas De Gran Canaria
city: El Palmar
country: Spain
facility: Novartis Investigative Site
state: Murcia
city: Pamplona
country: Spain
facility: Novartis Investigative Site
state: Navarra
city: Bilbao
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: San Sebastian
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Vigo
country: Spain
facility: Novartis Investigative Site
state: Pontevedra
city: La Laguna
country: Spain
facility: Novartis Investigative Site
state: Santa Cruz De Tenerife
city: Reus
country: Spain
facility: Novartis Investigative Site
state: Tarragona
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Burgos
country: Spain
facility: Novartis Investigative Site
city: Granollers
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Murcia
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Gothenburg
country: Sweden
facility: Novartis Investigative Site
city: Orebro
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
city: Vaxjo
country: Sweden
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Songkhla
country: Thailand
facility: Novartis Investigative Site
state: Hat Yai
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
state: THA
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Peterborough
country: United Kingdom
facility: Novartis Investigative Site
state: Cambridgeshire
city: Truro
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: Portsmouth
country: United Kingdom
facility: Novartis Investigative Site
state: Hants
city: Maidstone
country: United Kingdom
facility: Novartis Investigative Site
state: Kent
city: York
country: United Kingdom
facility: Novartis Investigative Site
state: North Yorkshire
city: Aberdeen
country: United Kingdom
facility: Novartis Investigative Site
state: Scotland
city: Ipswich
country: United Kingdom
facility: Novartis Investigative Site
state: Suffolk
city: Guildford
country: United Kingdom
facility: Novartis Investigative Site
state: Surrey
city: Sutton
country: United Kingdom
facility: Novartis Investigative Site
state: Surrey
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: Cardiff
country: United Kingdom
facility: Novartis Investigative Site
city: East Sussex
country: United Kingdom
facility: Novartis Investigative Site
city: Edinburgh
country: United Kingdom
facility: Novartis Investigative Site
city: Exeter
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
city: Oxford
country: United Kingdom
facility: Novartis Investigative Site
city: Plymouth
country: United Kingdom
facility: Novartis Investigative Site
city: Preston
country: United Kingdom
facility: Novartis Investigative Site
city: Sheffield
country: United Kingdom
facility: Novartis Investigative Site
city: Stoke-on-Trent
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Caputo R, Fabi A, Romagnoli E, Baldini E, Grasso D, Fenderico N, Michelotti A. Ribociclib Plus Letrozole in Italian Male Patients with Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Case Studies of Phase 3b CompLEEment-1 Trial. Breast Cancer (Dove Med Press). 2022 Oct 18;14:351-362. doi: 10.2147/BCTT.S376902. eCollection 2022.
citation: Salvador Bofill J, Moreno Anton F, Rodriguez Sanchez CA, Galve Calvo E, Hernando Melia C, Ciruelos Gil EM, Vidal M, Jimenez-Rodriguez B, De la Cruz Merino L, Martinez Janez N, Villanueva Vazquez R, de Toro Salas R, Anton Torres A, Alvarez Lopez IM, Gavila Gregori J, Quiroga Garcia V, Vicente Rubio E, De la Haba-Rodriguez J, Gonzalez-Santiago S, Diaz Fernandez N, Barnadas Molins A, Cantos Sanchez de Ibarguen B, Delgado Mingorance JI, Bellet Ezquerra M, de Casa S, Gimeno A, Martin M. Safety and efficacy of ribociclib plus letrozole in patients with HR+, HER2- advanced breast cancer: Results from the Spanish sub-population of the phase 3b CompLEEment-1 trial. Breast. 2022 Dec;66:77-84. doi: 10.1016/j.breast.2022.09.006. Epub 2022 Sep 28.
citation: De Laurentiis M, Caputo R, Mazza M, Mansutti M, Masetti R, Ballatore Z, Torrisi R, Michelotti A, Zambelli A, Ferro A, Generali D, Vici P, Coltelli L, Fabi A, Marchetti P, Ballestrero A, Spazzapan S, Frassoldati A, Sarobba MG, Grasso D, Zamagni C. Safety and Efficacy of Ribociclib in Combination with Letrozole in Patients with HR+, HER2- Advanced Breast Cancer: Results from the Italian Subpopulation of Phase 3b CompLEEment-1 Study. Target Oncol. 2022 Nov;17(6):615-625. doi: 10.1007/s11523-022-00913-x. Epub 2022 Sep 24.
citation: Campone M, De Laurentiis M, Zamagni C, Kudryavcev I, Agterof M, Brown-Glaberman U, Palacova M, Chatterjee S, Menon-Singh L, Wu J, Martin M. Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. Breast Cancer Res Treat. 2022 May;193(1):95-103. doi: 10.1007/s10549-022-06543-1. Epub 2022 Feb 25.
citation: De Laurentiis M, Borstnar S, Campone M, Warner E, Bofill JS, Jacot W, Dent S, Martin M, Ring A, Cottu P, Lu J, Ciruelos E, Azim HA, Chatterjee S, Zhou K, Wu J, Menon-Singh L, Zamagni C. Full population results from the core phase of CompLEEment-1, a phase 3b study of ribociclib plus letrozole as first-line therapy for advanced breast cancer in an expanded population. Breast Cancer Res Treat. 2021 Oct;189(3):689-699. doi: 10.1007/s10549-021-06334-0. Epub 2021 Aug 19.