Clinical trial NCT02513394: PALbociclib CoLlaborative Adjuvant Study
Official title: PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: HR+/HER2- breast cancer
Palbociclib
Lead sponsor: Alliance Foundation Trials, LLC.
Sponsor class: OTHER
Collaborators: name: Austrian Breast & Colorectal Cancer Study Group
name: NSABP Foundation Inc
name: PrECOG, LLC.
name: Breast International Group
name: Pfizer
First posted: 2015-07-31
Enrollment: 5796
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 is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC).

The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent prior to study specific procedures.
* Age ≥18 years (or per national guidelines).
* Pre- and postmenopausal women or men with Stage II (Stage IIA limited to max. 1000 patients) or Stage III early invasive breast cancer
* Patients with multicentric and/or multifocal and/or bilateral early invasive breast cancer are eligible if all histopathologically examined tumors meet pathologic criteria for ER+ and/or PR+ and HER2-.
* Patients must have histologically confirmed ER+ and/or PR+, HER2-, early invasive breast cancer.
* Patients must have undergone adequate (definitive) breast surgery for the current malignancy.

FFPE tumor tissue block must be confirmed to be received at the central sample repository prior to randomization.

* ECOG performance status 0-1.
* Patients must be able and willing to swallow and retain oral medication.
* Serum or urine pregnancy test must be negative in premenopausal women within 14 days of randomization, or in women with amenorrhea of less than 12 months at time of randomization.
* Patients who received neo/adjuvant therapy must be after last dose of chemotherapy and/or biologic therapy and must have sufficient resolution of side effects.
* Patients who received breast/axilla/post-mastectomy chest wall radiotherapy must be after last dose of radiotherapy and must have sufficient resolution of side effects.
* Patients must have sufficient resolution of any surgical side effects (no active wound healing complications).

-Patients must either be initiating or have already started adjuvant hormonal treatment. -

* Patients who already received neo/adjuvant endocrine therapy are eligible as long as they are enrolled within 12 months of initial histological diagnosis and after completing no more than 6 months of adjuvant endocrine therapy.
* Absolute neutrophil count ≥ 1,500/µL
* Platelets ≥ 100,000/ mm3
* Hemoglobin ≥ 10g/dL
* Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome.
* Aspartate amino transferase (AST or SGOT) and alanine amino transferase (ALT or SGPT) ≤ 1.5 × institutional ULN.
* Serum creatinine below the upper limit of the institutional normal range (ULN) or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.

Exclusion Criteria:

* Concurrent therapy with other Investigational Products.
* Prior therapy with any CDK inhibitor.
* Patients with Stage I or IV breast cancer are not eligible.
* History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib.
* Patients receiving any medications or substances that are potent inhibitors or inducers of
* CYP3A isoenzymes within 7 days of randomization.
* Uncontrolled intercurrent illness that would limit compliance with study requirements.
* Pregnant women, or women of childbearing potential without a negative pregnancy test within 14 days prior to randomization.
* Patients with a history of any malignancy are ineligible
* Patients who previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy.
* Patients on antiretroviral therapy.
* Patients with clinically significant history of any chronic liver disease.
* Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen therapy is allowable).

Primary outcomes:
measure: Invasive Disease Free Survival (iDFS)
timeFrame: 4 years
Secondary outcomes:
measure: Invasive Disease Free Survival (iDFS) Excluding Second Primary Invasive Cancers of Non-breast Origin.
timeFrame: 4 years
measure: Distant Recurrence-free Survival (DRFS)
timeFrame: 4 years
measure: Overall Survival (OS)
timeFrame: 4 years
measure: Locoregional Recurrences-free Survival (LRRFS)
timeFrame: 4 years
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Mitchell Cancer Institute
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center PC - Providence
state: Alabama
city: Anchorage
country: United States
facility: Katmai Oncology Group
state: Alaska
city: Anchorage
country: United States
facility: Providence Alaska Cancer Center
state: Alaska
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Anaheim
country: United States
facility: Kaiser Permanente Anaheim Medical Center
state: California
city: Baldwin Park
country: United States
facility: Kaiser Permanente Baldwin Park Medical Center
state: California
city: Bellflower
country: United States
facility: Kaiser Permanente Bellflower Medical Center
state: California
city: Fontana
country: United States
facility: Kaiser Permanente Fontana Medical Center
state: California
city: Greenbrae
country: United States
facility: Marin Cancer Care
state: California
city: Greenbrae
country: United States
facility: Marin Cancer Center
state: California
city: Harbor City
country: United States
facility: Kaiser Permanente Harbor City Medical Center
state: California
city: Irvine
country: United States
facility: Kaiser Permanente Irvine Medical Center
state: California
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center - Todd Cancer Institute
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Sunset Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland Medical Center
state: California
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation Health Care
state: California
city: Panorama City
country: United States
facility: Kaiser Permanente Panorama City Medical Center
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Riverside Medical Center
state: California
city: Roseville
country: United States
facility: Kaiser Permanente Roseville Medical Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento Medical Center
state: California
city: San Diego
country: United States
facility: University of California
state: California
city: San Diego
country: United States
facility: Kaiser Permanente San Diego Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Comprehensive Cancer Center
state: California
city: San Jose
country: United States
facility: Kaiser Permanente San Jose Medical Center
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente San Leandro Medical Center
state: California
city: San Marcos
country: United States
facility: Kaiser Permanente San Marcos Medical Center
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara Medical Center
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente South San Francisco Medical Center
state: California
city: Stanford
country: United States
facility: Stanford Women's Cancer Center
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Vallejo Medical Center
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Walnut Creek Medical Center
state: California
city: West Los Angeles
country: United States
facility: Kaiser Permanente Cadillac Medical Center
state: California
city: Woodland Hills
country: United States
facility: Kaiser Permanente Woodland Hills Medical Center
state: California
city: Denver
country: United States
facility: Western States Cancer Research NCORP
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Britain
country: United States
facility: Memorial Sloan Cancer Center - Hartford Healthcare Center Institute at HOCC
state: Connecticut
city: Newark
country: United States
facility: Christiana Health System - Christiana Hospital
state: Delaware
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine Sylvester Cancer Center
state: Florida
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Orlando
country: United States
facility: Orlando Health Cancer Institute
state: Florida
city: Albany
country: United States
facility: Phoebe Putney Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Cancer Center LAPS
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialist of Central Illinois
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System - Evanston Hospital
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology Hematology Associates Limited
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare-Peoria
state: Illinois
city: Rockford
country: United States
facility: OSF Saint Anthony Medical Center
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc.
state: Illinois
city: Skokie
country: United States
facility: NorthShore Hematology Oncology-Libertyville
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University - Melvin and Bren Simon Cancer Center LAPS
state: Indiana
city: Muncie
country: United States
facility: IU Health Ball Memorial Hospital
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic PC-William R Bliss Cancer Center
state: Iowa
city: Ames
country: United States
facility: McFarland Clinic, P.C.
state: Iowa
city: Cedar Rapids
country: United States
facility: Physicians' Clinic of Iowa PC
state: Iowa
city: Des Moines
country: United States
facility: Iowa Oncology Research Assoc
state: Iowa
city: Des Moines
country: United States
facility: Medical Oncology and Hematology Associates - Des Moines
state: Iowa
city: Waterloo
country: United States
facility: Covenant Medical Center
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky-Markey Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute - Brownsboro
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Bangor
country: United States
facility: Eastern Maine Medical Center d/b/a Northern Light Cancer Institute
state: Maine
city: Scarborough
country: United States
facility: New England Cancer Specialists - Scarborough
state: Maine
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: MedStar Good Samaritan Hospital
state: Maryland
city: Baltimore
country: United States
facility: MedStar Franklin Square Medical Center Winberg Cancer Institute
state: Maryland
city: Baltimore
country: United States
facility: Medstar Union Memorial Hospital
state: Maryland
city: Baltimore
country: United States
facility: JHU Sidney Kimmel Comprehensive Cancer Center LAPS
state: Maryland
city: Baltimore
country: United States
facility: Frederick Regional Health System James M Stockman Cancer Institute
state: Maryland
city: Bethesda
country: United States
facility: Maryland Oncology Hematology PA
state: Maryland
city: Salisbury
country: United States
facility: Tidal Health Peninsula Regional
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Lowell
country: United States
facility: Lowell General Hospital
state: Massachusetts
city: Plymouth
country: United States
facility: Beth Israel Deaconess Hospital - Plymouth Jordan Club Cancer Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer Research Consortium of West Michigan NCORP
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Butterworth Research Pharmacy
state: Michigan
city: Livonia
country: United States
facility: Trinity Health Michigan
state: Michigan
city: Duluth
country: United States
facility: Essentia Health NCORP
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic-Rochester
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Cloud
country: United States
facility: Coborn Cancer Center at Saint Cloud Hospital
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro Minnesota Community Oncology Research Consortium
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro Minnesota Oncology Research Consortium
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Rolla
country: United States
facility: Phelps Country Regional Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital Saint Louis
state: Missouri
city: Springfield
country: United States
facility: Cancer Research for the Ozarks NCORP
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Hematology and Oncology
state: Nebraska
city: Lincoln
country: United States
facility: Southeast Nebraska Cancer Center
state: Nebraska
city: Omaha
country: United States
facility: Cancer Alliance of Nebraska
state: Nebraska
city: Omaha
country: United States
facility: Missouri Valley Cancer Consortium
state: Nebraska
city: Concord
country: United States
facility: New Hampshire Oncology-Hematology PA, Concord
state: New Hampshire
city: Hooksett
country: United States
facility: New Hampshire Oncology-Hematology PA
state: New Hampshire
city: Hooksett
country: United States
facility: Solinsky Center for Cancer Care
state: New Hampshire
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center - Nashua
state: New Hampshire
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Center Institute of New Jersey
state: New Jersey
city: Somerville
country: United States
facility: Robert Wood Johnson University Hospital Somerset
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center - Einstein Campus
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Cooperstown
country: United States
facility: Mary Imogene Bassett Hospital
state: New York
city: East Syracuse
country: United States
facility: Hematology Oncology Associates of Central New York - East Syracuse
state: New York
city: Jamaica
country: United States
facility: Queens Hospital Center
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health NCORP
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center - New York
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center - LAPS
state: New York
city: Oneonta
country: United States
facility: Oneonta FoxCare Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center/Levine Cancer Institute
state: North Carolina
city: Charlotte
country: United States
facility: The Charlotte-Mecklenburg Hospital Authority
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Cone Health Cancer Center
state: North Carolina
city: Kinston
country: United States
facility: Kinston Medical Specialists, PA
state: North Carolina
city: Pinehurst
country: United States
facility: First Health of the Carolinas - Moore Regional Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Cancer Center/Fairview Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Mayfield Heights
country: United States
facility: Cleveland Clinic Cancer Center/Hillcrest Hospital
state: Ohio
city: Lawton
country: United States
facility: Cancer Centers of Southwest Oklahoma Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Dunmore
country: United States
facility: Hematology & Oncology Associates of Northeastern PA
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania/Abramson Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC MaGee Women's Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute- Hillman Cancer Center
state: Pennsylvania
city: Wyomissing
country: United States
facility: Reading Hospital/McGlinn Cancer Institute
state: Pennsylvania
city: York
country: United States
facility: WellSpan Health York Cancer Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Columbia
country: United States
facility: Lexington Medical Center/Lexington Oncology Associates
state: South Carolina
city: Aberdeen
country: United States
facility: Avera Cancer Institute-Aberdeen
state: South Dakota
city: Rapid City
country: United States
facility: Monument Health Rapid City Hospital
state: South Dakota
city: Rapid City
country: United States
facility: Rapid City Regional Hospital/Regional Cancer Care Institute
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt University/Ingram Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Nashville General Hospital at Meharry
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Laredo
country: United States
facility: Doctors Hospital of Laredo
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute - University of Utah
state: Utah
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Richmond
country: United States
facility: VCU Massey Cancer Center
state: Virginia
city: Charleston
country: United States
facility: CAMC Cancer Center
state: West Virginia
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
city: Green Bay
country: United States
facility: HSHS Saint Vincent Hospital
state: Wisconsin
city: La Crosse
country: United States
facility: Gunderson Lutheran Medical Center
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Wheaton Franciscan Healthcare - St. Joseph
state: Wisconsin
city: Milwaukee
country: United States
facility: Columbia St. Mary's Water Tower Medical Commons
state: Wisconsin
city: Racine
country: United States
facility: Wheaton Franciscan Healthcare-All Saints
state: Wisconsin
city: Waukesha
country: United States
facility: Orchard Healthcare Research Inc.
state: Wisconsin
city: Waukesha
country: United States
facility: UW Cancer Center at ProHealth Care
state: Wisconsin
city: Wauwatosa
country: United States
facility: Wheaton Franciscan Healthcare - Wauwatosa
state: Wisconsin
city: Bowral
country: Australia
facility: Southern Highlands Cancer Centre
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Coffs Harbour Health Campus - MNCCI
state: New South Wales
city: Gateshead
country: Australia
facility: The Breast & Endocrine Centre
state: New South Wales
city: Gosford
country: Australia
facility: Gosford Hospital
state: New South Wales
city: Macquarie Park
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Orange
country: Australia
facility: Orange Health Service
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Drive
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Epping
country: Australia
facility: The Northern Hospital
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Health - Frankston Hospital
state: Victoria
city: Geelong
country: Australia
facility: University Hospital, Geelong
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: Peninsula Health - Frankston Hospital
state: Victoria
city: St. Albans
country: Australia
facility: Western Health, Sunshine Hospital
state: Victoria
city: Warrnambool
country: Australia
facility: South West Healthcare, Warrnambool
state: Victoria
city: Bunbury
country: Australia
facility: St John of God Bunbury Hospital
state: Western Australia
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: Breast Cancer Research Centre - WA
state: Western Australia
city: Feldkirch
country: Austria
facility: LKH Feldkirch, Department of Internal Medicine
city: Graz
country: Austria
facility: LKH Univ Klinikum Graz, Dept of Internal Med. and Oncology
city: Graz
country: Austria
facility: Medical University of Graz, Gyn. Dept.
city: Innsbruck
country: Austria
facility: University Hospital Innsbruck, Department of Obstetrics and Gynaecology
city: Kufstein
country: Austria
facility: BKH Kufstein, Innere Medizin
city: Leoben
country: Austria
facility: LKH Hochsteiermark Leoben
city: Linz
country: Austria
facility: Hospital of the Sisters of Charity Linz, Surg. Dept., Breast Health Center
city: Linz
country: Austria
facility: Kepler Universitätsklinikum Med. Campus III
city: Mistelbach
country: Austria
facility: Weinviertelklinikum Mistelbach, Department of Surgery
city: Ried
country: Austria
facility: BHS Ried, Abt. f. Gynäkologie
city: Salzburg
country: Austria
facility: LKH Salzburg, Univ. Klinik f. Innere Med. III
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten, Innere Medizin
city: St. Veit an der Glan
country: Austria
facility: Breast Centre Dr. Wette Viktor
city: Steyr
country: Austria
facility: Phyrn-Eisenwurzen Klinikum Steyr
city: Vienna
country: Austria
facility: Medical University of Vienna Department of Obstetrics and Gynaecology
city: Vienna
country: Austria
facility: Medical University Vienna - Coop Group Surgery/Oncology
city: Vienna
country: Austria
facility: Hospital Hietzing, Gynecology
city: Vienna
country: Austria
facility: St. Josef Krankenhaus, Department of Internal I
city: Vienna
country: Austria
facility: Klinik Ottakring
city: Voecklabruck
country: Austria
facility: Salzkammergut-Klinikum Vöcklabruck
city: Weiz
country: Austria
facility: Brustordination Dr. Thiel
city: Wels
country: Austria
facility: Klinikum Wels - Grieskirchen GmbH, Department of Internal Medicine IV
city: Wolfsberg
country: Austria
facility: LKH Wolfsberg, Department of Surgery
city: Wr. Neustadt
country: Austria
facility: Landesklinikum Wr. Neustadt, Department of Surgery
city: Aalst
country: Belgium
facility: OLV ziekenhuis Aalst/Radiotherapy-Oncology
city: Brussels
country: Belgium
facility: CHU Saint Pierre/Medical Oncology
city: Brussels
country: Belgium
facility: Institut Jules Bordet/Medical Oncology Department
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc, Oncologisch centrum
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi - Oncologie-hématologie
city: Edegem
country: Belgium
facility: University Hospital Antwerp (UZA)
city: Leuven
country: Belgium
facility: UZ Leuven/ Gynaecologie-Oncologie
city: Liège
country: Belgium
facility: CHC - Saint-Joseph/Oncology-Hematology
city: Liège
country: Belgium
facility: CHU Sart Tilman Liège (Medical Oncology)
city: Namur
country: Belgium
facility: Clinique et Maternite Sainte-Elisabeth - Oncology Department
city: Verviers
country: Belgium
facility: CHR - Centre Hospitalier Peltzer La Tourelle/ Oncology Department
city: Wilrijk
country: Belgium
facility: GZA Ziekenhuizen (Campus Sint-Augustinus) / Oncologische Centrum
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre - Dept. of Oncology
state: Alberta
city: Abbotsford
country: Canada
facility: BC Cancer Agency- Abbotsford Centre
state: British Columbia
city: Kelowna
country: Canada
facility: BC Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer Agency - Vancouver Cancer Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba - St. Boniface Hospital
state: Manitoba
city: Moncton
country: Canada
facility: The Vitalite Health Network - Dr. Leon Richard
state: New Brunswick
city: Saint John
country: Canada
facility: Horizon Health Network - Saint John Regional Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital, Cancer Centre of Southeastern Ontario/Oncology
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Regional Cancer Center
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Health System
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook
state: Ontario
city: Toronto
country: Canada
facility: University Health Network Princess Margaret Cancer Centre
state: Ontario
city: Montréal
country: Canada
facility: The Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: CHUM Hôtel Dieu
state: Quebec
city: Québec
country: Canada
facility: CHU de Québec - Hôpital du St Sacrement
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Center, University of Saskatchewan
state: Saskatchewan
city: Aachen
country: Germany
facility: University Hospital Aachen
city: Berlin
country: Germany
facility: Praxisklinik Krebsheilkunde für Frauen
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch
city: Berlin
country: Germany
facility: Studienzentrum City
city: Bottrop
country: Germany
facility: Marienhospital Bottrop, Klinik für Gynäkologie und Geburtshilfe
city: Braunschweig
country: Germany
facility: Studien GbR Braunschweig, Lorenz&HeckerWesche
city: Ebersberg
country: Germany
facility: Praxis und Tagesklinik für gynäkologische Onkologie,
city: Eggenfelden
country: Germany
facility: MVZ Eggenfelden
city: Erlangen
country: Germany
facility: Frauenklinik/University Hospital Erlangen
city: Frankfurt
country: Germany
facility: Centrum für Hämatologie und Onkologie Bethanien
city: Frankfurt
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Frankfurt
country: Germany
facility: Klinikum Frankfurt Höchst
city: Fürth
country: Germany
facility: Onkol. GP Dres. med. Wilke/Wagner/Petzoldt
city: Halle (Saale)
country: Germany
facility: Universitätsfrauenklinik Halle (Saale)
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf, Department of Gynecology
city: Hamburg
country: Germany
facility: Albertinen Krankenhaus
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe
city: Kassel
country: Germany
facility: Elisabeth Krankenhaus Kassel Brustzentrum
city: Leipzig
country: Germany
facility: St. Elisabeth Krankenhaus Leipzig
city: Limburg
country: Germany
facility: St. Vincenz KH Limburg Frauenklinik
city: Lübeck
country: Germany
facility: UKSH Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: München
country: Germany
facility: Praxis Gynäkologie Arabella
city: Oldenburg
country: Germany
facility: University Clinic Oldenburg
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH
city: Rottweil
country: Germany
facility: HELIOS Klinik Rottweil - Gynäkologie
city: Wiesbaden
country: Germany
facility: St. Josefs-Hospital
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet - "B" Belgyógyászati Onkológiai és Klinikai Farmakológiai Osztály
city: Budapest
country: Hungary
facility: Uzsoki Utcai Kórház - Onkoradiológia, Sugárterápia, Fővárosi Onkoradiológiai Központ
city: Debrecen
country: Hungary
facility: University of Debrecen Medical Center, Clinic of Oncology
city: Győr
country: Hungary
facility: Petz Aladár Megyei Oktatókórház - Onkoradiológiai Osztály
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Általános Orvostudományi Kar Szent-Györgyi Albert Klinikai Központ, Onkoterápiás Klinika
city: Cork
country: Ireland
facility: Bon Secours Hospital, Cork
city: Cork
country: Ireland
facility: Cork University Hospital, Oncology Clinical Trials Unit
city: Dublin
country: Ireland
facility: Beaumont Hospital - Cancer Clinical Trials Unit
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin
country: Ireland
facility: St James's Hospital, Cancer Clinical Trials Office, Old Admin Building,
city: Dublin
country: Ireland
facility: St Vincent Hospital - Medical Oncology Research Department
city: Limerick
country: Ireland
facility: University Hospital Limerick, Midwestern Cancer Centre
city: Sligo
country: Ireland
facility: Sligo University Hospital
city: Waterford
country: Ireland
facility: University Hospital Waterford, Cancer Research Department
city: Petah Tikva
country: Israel
facility: Rabin Medical Center (RMC)
state: Central
city: Ramat Gan
country: Israel
facility: Sheba Medical Center Tel Hashomer
state: Tel Aviv
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara
city: Florence
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi/Florence University/Radiation Oncology Unit
city: Genoa
country: Italy
facility: Department of Internal Medicine (DIMI) - IRCCS San Martino University Hospital
city: Grosseto
country: Italy
facility: P.O. Misericordia AUSL Toscana Sud Est
city: Legnago
country: Italy
facility: Ospedale "Mater Salutis" di Legnago, Dept. of Medical Oncology
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) IRCCS
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Monza
country: Italy
facility: Policlinico di Monza - Istituto di Oncologia del Policlinico di Monza
city: Parma
country: Italy
facility: Medical Oncology Unit; University Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)
city: Prato
country: Italy
facility: Nuovo Ospedale di Prato (NOP) - Azienda USL4 Prato
city: Treviglio
country: Italy
facility: ASST Bergamo Ovest
city: Turin
country: Italy
facility: S. Anna Hospital (Ospedale Sant'Anna)- Turin
city: Nagoya
country: Japan
facility: Nagoya City University Hospital/Dept. of Breast & Endocrine Surgery
state: Aichi
city: Sapporo
country: Japan
facility: Department of Breast Surgery National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Kyoto
country: Japan
facility: Kyoto University Hospital/Breast Surgery
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Hematology-Medical Oncology
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Medical Doctor at Department of Medical Oncology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Centre, Breast Cancer Center, Department of Medicine, Division of Hematology/Oncology
city: Monterrey
country: Mexico
facility: Centro Médico Zambrano Hellion
state: Nuevo León
city: Toluca de Lerdo
country: Mexico
facility: Centro Oncológico Estatal ISSEMYM
state: Toluca
city: Mexico City
country: Mexico
facility: National Cancer Institute Mexico, Breast Cancer Department
city: Den Haag
country: Netherlands
facility: Hagaziekenhuis
city: Eindhoven
country: Netherlands
facility: Máxima Medisch Centrum
city: Geleen
country: Netherlands
facility: Zuyderland Ziekenhuis, Oncology
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
city: Zaandam
country: Netherlands
facility: Zaans Medical Center
city: Zwolle
country: Netherlands
facility: Isala, Dept of Medical Oncology
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne (UCK), Klinika Onkologii I Radioterapii
city: Opole
country: Poland
facility: Opolskie Centrum Onkologii, Oddzial Onkologii Klinicznej
city: Warsaw
country: Poland
facility: Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
city: Łódź
country: Poland
facility: Instytut MSF Spółka z ograniczoną odpowiedzialnością
city: Lisboa
country: Portugal
facility: Instituto Português de Oncologia (IPO) de Lisboa Francisco Gentil
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Lisboa
country: Portugal
facility: CUF Descobertas Hospital, Hemato-Oncologia
city: Lisbon
country: Portugal
facility: Centro Clinico Champalimaud
city: Porto
country: Portugal
facility: Instituto Português de Oncologia (IPO) Francisco Gentil do Porto
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC)
city: A Coruña
country: Spain
facility: Centro Oncologico de Galicia
city: Alicante
country: Spain
facility: Hospital General Universitario Alicante
city: Badalona
country: Spain
facility: ICO Badalona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Quirón Dexeus
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Barcelona
country: Spain
facility: Hospital General de Granollers
city: Barcelona
country: Spain
facility: Instituto Catalán de Oncología (ICO) de L'Hospitalet de Llobregat
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Castellón De La Plana
country: Spain
facility: Consorcio Hospitalario Provincial de Castellon
city: Cáceres
country: Spain
facility: San Pedro de Alcántara
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Girona
country: Spain
facility: ICO/ H. Josep Trueta
city: León
country: Spain
facility: Complejo asistencial universitario de Leon
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital La Paz, Servicio de Oncologia Médica
city: Madrid
country: Spain
facility: CIOCC - Centro Integral Oncológico Clara Campal / Hospital HM Universitario Sanchinarro
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro Majadahonda, Oncologia Médica
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Alcorcón
city: Murcia
country: Spain
facility: Hospital General Universitario José Mª Morales Meseguer
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Clínico Universitario Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Palma
country: Spain
facility: Hospitali Universitari son Espases
city: Palma
country: Spain
facility: Hospital Son Llatzer
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
city: Sant Joan Despì
country: Spain
facility: Hospital de Sant Juan Despi Moisés Broggi
city: Santiago
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Unversitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Quirón Sagrado Corazón
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hosital Arnau de Vilanova Valencia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Gävle
country: Sweden
facility: Gävle Hospital, Dept. of Oncology
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital, Dept. Oncology
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset, Bröstcentrum A2:00
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset Uppsala (University Hospital), Onkologkliniken
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro (University Hospital) Örebro, Onkologkliniken
city: Baden
country: Switzerland
facility: Kantonspital Baden
state: Aargau
city: Thun
country: Switzerland
facility: Spital STS AG, Onkologiezentrum Thun-Berner Oberland
state: Bern
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève
state: Geneva
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
state: Graubünden
city: Bellinzona
country: Switzerland
facility: IOSI-Breast Cancer Unit-Ospedale San Giovanni-Bellinzona
state: Tessin
city: Locarno
country: Switzerland
facility: Fondazione Oncologia Lago Maggiore, Locarno
state: Tessin
city: Basel
country: Switzerland
facility: Dep. Oncology, University Hospital
city: Fribourg
country: Switzerland
facility: HFR Fribourg, Oncology Department
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital, Dept. of Medical Oncology
city: Luzern
country: Switzerland
facility: Onkologisches Forschungszentrum Klinik St. Anna, Hirslanden
city: St.Gallen
country: Switzerland
facility: Kantonsspital St.Gallen, Onkologie/Hämatologie
city: Zurich
country: Switzerland
facility: Brust-Zentrum Zürich
city: Zurich
country: Switzerland
facility: Universitätsspital Zürich, Klinik für Onkologie
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital/General Surgery
state: Changhua County
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital, Division of Hemato-Oncology, Dept. Internal Medicine
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital/Department of Surgery
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital/General Surgery
city: Birmingham
country: United Kingdom
facility: City Hospital Birmingham
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: Chelsea
country: United Kingdom
facility: Royal Marsden Hospital Chelsea
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Marsden Sutton
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital, Kent Oncology Centre
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Northern Centre for Cancer Care
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS TRUST UK
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital, Sheffield Teaching Hospitals
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust, Oncology Trials, Sunrise Centre
Study officials:
affiliation: Alliance Foundation Trials, LLC.
name: Evanthia Galanis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Erica Mayer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Angela DeMichele, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ABCSG, Medical University Vienna
name: Michael Gnant, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mayer EL, Fesl C, Hlauschek D, Garcia-Estevez L, Burstein HJ, Zdenkowski N, Wette V, Miller KD, Balic M, Mayer IA, Cameron D, Winer EP, Ponce Lorenzo JJ, Lake D, Pristauz-Telsnigg G, Haddad TC, Shepherd L, Iwata H, Goetz M, Cardoso F, Traina TA, Sabanathan D, Breitenstein U, Ackerl K, Metzger Filho O, Zehetner K, Solomon K, El-Abed S, Theall KP, Lu DR, Dueck A, Gnant M, DeMichele A. Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03). J Clin Oncol. 2022 Feb 10;40(5):449-458. doi: 10.1200/JCO.21.01918. Epub 2022 Jan 7.
citation: Gnant M, Dueck AC, Frantal S, Martin M, Burstein HJ, Greil R, Fox P, Wolff AC, Chan A, Winer EP, Pfeiler G, Miller KD, Colleoni M, Suga JM, Rubovsky G, Bliss JM, Mayer IA, Singer CF, Nowecki Z, Hahn O, Thomson J, Wolmark N, Amillano K, Rugo HS, Steger GG, Hernando Fernandez de Aranguiz B, Haddad TC, Perello A, Bellet M, Fohler H, Metzger Filho O, Jallitsch-Halper A, Solomon K, Schurmans C, Theall KP, Lu DR, Tenner K, Fesl C, DeMichele A, Mayer EL; PALLAS groups and investigators. Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03). J Clin Oncol. 2022 Jan 20;40(3):282-293. doi: 10.1200/JCO.21.02554. Epub 2021 Dec 7.
citation: Mayer EL, Dueck AC, Martin M, Rubovszky G, Burstein HJ, Bellet-Ezquerra M, Miller KD, Zdenkowski N, Winer EP, Pfeiler G, Goetz M, Ruiz-Borrego M, Anderson D, Nowecki Z, Loibl S, Moulder S, Ring A, Fitzal F, Traina T, Chan A, Rugo HS, Lemieux J, Henao F, Lyss A, Antolin Novoa S, Wolff AC, Vetter M, Egle D, Morris PG, Mamounas EP, Gil-Gil MJ, Prat A, Fohler H, Metzger Filho O, Schwarz M, DuFrane C, Fumagalli D, Theall KP, Lu DR, Bartlett CH, Koehler M, Fesl C, DeMichele A, Gnant M. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2021 Feb;22(2):212-222. doi: 10.1016/S1470-2045(20)30642-2. Epub 2021 Jan 15.
citation: Dieras V, Rugo HS, Schnell P, Gelmon K, Cristofanilli M, Loi S, Colleoni M, Lu DR, Mori A, Gauthier E, Huang Bartlett C, Slamon DJ, Turner NC, Finn RS. Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer. J Natl Cancer Inst. 2019 Apr 1;111(4):419-430. doi: 10.1093/jnci/djy109.