Clinical trial NCT05169567: Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
Official title: postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Neoplasm
Neoplasm Metastasis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-12-27
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer
* Have radiologic evidence of disease progression or recurrence either

  * On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or
  * On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer
* Must be deemed appropriate for treatment with ET
* If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
* Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable disease)
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
* Have adequate renal, hematologic, and hepatic organ function
* Must be able to swallow capsules/tablets

Exclusion Criteria:

* Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
* Have symptomatic or untreated central nervous system metastasis
* Have received any systemic therapy between disease recurrence/progression and study screening
* Have received more than 1 line of therapy for advanced or metastatic disease.
* Have received prior chemotherapy for metastatic breast cancer (MBC)
* Have received prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders \[SERDs\] and non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or protein kinase B (AKT)-inhibitor

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Randomization to the date of first documented progression of disease or death from any cause (Up to 21 Months)
Secondary outcomes:
measure: Progression Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
timeFrame: Randomization to the date of first documented progression of disease or death from any cause (Up to 22 Months)
measure: Objective Response Rate (ORR): Percentage of Participants Who Achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
timeFrame: Randomization until measured progressive disease (Up to 22 Months)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Fullerton
country: United States
facility: Providence Medical Foundation
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: Los Angeles
country: United States
facility: TRIO-US (Translational Research in Oncology-US)
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology/Oncology - Parkside
state: California
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
city: Torrance
country: United States
facility: Torrance Memorial Physician Network / Cancer Care
state: California
city: Whittier
country: United States
facility: PIH Health Hematology Medical Oncology
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center - Hale Parkway
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI
state: Florida
city: Hollywood
country: United States
facility: Millennium Oncology Research Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinics, Sylvester Cancer Center
state: Florida
city: Pensacola
country: United States
facility: Woodlands Medical Specialists, PA
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists EAST/Sarah Cannon Research Institute/SCRI
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Macon
country: United States
facility: Central Georgia Cancer Care
state: Georgia
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Baton Rouge
country: United States
facility: Hematology Oncology Clinic- Baton Rouge/Sarah Cannon Research Institute/SCRI
state: Louisiana
city: Lake Charles
country: United States
facility: Clinical Trials of SWLA
state: Louisiana
city: Lewiston
country: United States
facility: Central Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Mfsmc-Hjwci
state: Maryland
city: Clinton
country: United States
facility: Maryland Oncology Hematology, P.A. - Clinton
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Danvers
country: United States
facility: MGH Northshore Cancer Center
state: Massachusetts
city: Fairhaven
country: United States
facility: Southcoast Centers for Cancer Care
state: Massachusetts
city: Foxboro
country: United States
facility: Dana-Farber Cancer Institute - Foxborough
state: Massachusetts
city: Methuen
country: United States
facility: Dana Farber Cancer Center Merrimack Valley
state: Massachusetts
city: Milford
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Newton
country: United States
facility: Mass General Cancer Center
state: Massachusetts
city: South Weymouth
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Worcester
country: United States
facility: Reliant Medical Group
state: Massachusetts
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Londonderry
country: United States
facility: Dana Farber Cancer Center Londonderry
state: New Hampshire
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center
state: New Mexico
city: Providence
country: United States
facility: Lifespan Cancer Institute
state: Rhode Island
city: Chattanooga
country: United States
facility: Tennessee Oncology-Chattanooga /Sarah Cannon Research Institute/SCRI
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute/SCRI
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology-Nashville/Sarah Cannon Research Institute/SCRI
state: Tennessee
city: Bedford
country: United States
facility: Texas Oncology - Bedford
state: Texas
city: Denton
country: United States
facility: Texas Oncology - Denton
state: Texas
city: El Paso
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: McKinney
country: United States
facility: Texas Oncology - McKinney
state: Texas
city: McKinney
country: United States
facility: Woodlands Medical Specialists, PA
state: Texas
city: Mesquite
country: United States
facility: Woodlands Medical Specialists, PA
state: Texas
city: Plano
country: United States
facility: Texas Oncology - Plano East
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano West
state: Texas
city: San Antonio
country: United States
facility: Mays Cancer Center
state: Texas
city: The Woodlands
country: United States
facility: US Oncology
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler Cancer Center
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Saint George
country: United States
facility: Intermountain Healthcare - St. George
state: Utah
city: Burlington
country: United States
facility: The University of Vermont Medical Center Inc.
state: Vermont
city: Winchester
country: United States
facility: Shenandoah Oncology, P.C.
state: Virginia
city: Buenos Aires
country: Argentina
facility: Fundación Respirar
state: Buenos Air
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Air
city: Caba
country: Argentina
facility: Fundación Cenit Para La Investigación En Neurociencias
state: Ciudad Autónoma De Buenos Aires
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto
state: Córdoba
city: San Miguel de Tucumán
country: Argentina
facility: Centro Medico San Roque
state: Tucumán
city: San Juan
country: Argentina
facility: CER San Juan
city: Brasschaat
country: Belgium
facility: Algemeen Ziekenhuis klina
state: Antwerpen
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
state: Limburg
city: Namur
country: Belgium
facility: CHU UCL Namur/Site Sainte Elisabeth
city: Pardubice
country: Czechia
facility: Multiscan
state: Pardubický Kraj
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Copenhagen
country: Denmark
facility: Herlev and Gentofte Hospital
state: Hovedstaden
city: Herning
country: Denmark
facility: Regionshospitalet Gødstrup
state: Midtjylland
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
state: Aquitaine
city: Brest
country: France
facility: CHRU de Brest
state: Finistère
city: Nantes
country: France
facility: Hôpital privé du Confluent SAS
state: Loire-Atlantique
city: La Roche-sur-Yon
country: France
facility: CHD Vendee
state: Vendée
city: Patras
country: Greece
facility: University Hospital of Patras
state: Achaḯa
city: Athens
country: Greece
facility: Alexandra Hospital
state: Attikí
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Irakleío
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz
state: Bács-Kiskun
city: Gyor
country: Hungary
facility: Petz Aladar Egyetemi Oktato Korhaz
state: Győr-Moson-Sopron
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
state: HaDarom
city: Kfar Saba
country: Israel
facility: Meir Medical Center
state: HaMerkaz
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
state: Tell Abīb
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
state: Yerushalayim
city: Misterbianco
country: Italy
facility: Humanitas Istituto Clinico Catanese
state: Catania
city: Meldola
country: Italy
facility: IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
state: Emilia-Romagna
city: Udine
country: Italy
facility: P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
state: Friuli-Venezia Giulia
city: Bari
country: Italy
facility: Instituto Tumori Giovanni Paolo II
city: Grosseto
country: Italy
facility: Ospedale Misericordia di Grosseto
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Viterbo
country: Italy
facility: ASL Viterbo Ospedale Belcolle
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyǒnggi-do
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
state: Taegu-Kwangyǒkshi
city: Mexicali
country: Mexico
facility: Centro de Investigacion en Artritis y Osteoporosis SC
state: Baja California
city: Tijuana
country: Mexico
facility: COI Tijuana - Centro Oncológico Internacional
state: Baja California
city: Guadalajara
country: Mexico
facility: Centro Oncológico Internacional (COI)
state: Jalisco
city: Monterrey
country: Mexico
facility: Centro Regiomontano de Investigación
state: Nuevo León
city: San Luis Potosi
country: Mexico
facility: Oncologico Potosino, S.C.
state: San Luis Potosí
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia - Oddzial Onkologii
state: Mazowieckie
city: Opole
country: Poland
facility: Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
state: Opolskie
city: A Coruña
country: Spain
facility: CHUAC-Hospital Teresa Herrera
state: A Coruña [La Coruña]
city: Palma
country: Spain
facility: Hospital Universitari Son Espases
state: Balears [Baleares]
city: Barcelona
country: Spain
facility: Parc de Salut Mar - Hospital del Mar
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalunya [Cataluña]
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia, Región De
city: Malaga
country: Spain
facility: H.R.U Málaga - Hospital Materno-infantil
state: Málaga
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
state: Tarragona [Tarragona]
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
state: Valenciana, Comunitat
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
state: Stockholms
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
state: Örebro Län [se-18]
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center
state: Tainan
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi General Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
city: Karsiyaka
country: Turkey
facility: Izmir Medical Park Hospital
state: İzmir
city: Meram
country: Turkey
facility: Necmettin Erbakan Meram Medical Fac.
state: Konya
city: Adana
country: Turkey
facility: Adana City Hospital
city: Ankara
country: Turkey
facility: Ankara Gülhane Eitim ve Aratrma Hastanesi
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Diyarbakir
country: Turkey
facility: Dicle Üniversitesi
city: Edirne
country: Turkey
facility: Trakya University
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
city: Malatya
country: Turkey
facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: