NCT02513394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
5,796

participants targeted

Target at P75+ for phase_3 breast-cancer

Timeline
31mo left

Started Aug 2015

Longer than P75 for phase_3 breast-cancer

Geographic Reach
20 countries

416 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Aug 2015Dec 2028

First Submitted

Initial submission to the registry

July 29, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 13, 2022

Completed
6.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Expected
Last Updated

February 10, 2026

Status Verified

January 1, 2025

Enrollment Period

5.3 years

First QC Date

July 29, 2015

Results QC Date

February 1, 2022

Last Update Submit

January 22, 2026

Conditions

Keywords

HR+/HER2- breast cancerPalbociclib

Outcome Measures

Primary Outcomes (1)

  • Invasive Disease Free Survival (iDFS)

    Invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, second primary invasive cancer of non-breast origin or death from any cause. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported.

    4 years

Secondary Outcomes (4)

  • Invasive Disease Free Survival (iDFS) Excluding Second Primary Invasive Cancers of Non-breast Origin.

    4 years

  • Distant Recurrence-free Survival (DRFS)

    4 years

  • Overall Survival (OS)

    4 years

  • Locoregional Recurrences-free Survival (LRRFS)

    4 years

Study Arms (2)

Arm A

EXPERIMENTAL

Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.

Drug: PalbociclibDrug: Standard Adjuvant Endocrine Therapy

Arm B

OTHER

Standard adjuvant endocrine therapy for a duration of at least 5 years.

Drug: Standard Adjuvant Endocrine Therapy

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +6 more criteria

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (437)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

Location

Southern Cancer Center PC - Providence

Mobile, Alabama, 36608, United States

Location

Katmai Oncology Group

Anchorage, Alaska, 99508, United States

Location

Providence Alaska Cancer Center

Anchorage, Alaska, 99508, United States

Location

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Location

Kaiser Permanente Anaheim Medical Center

Anaheim, California, 92806, United States

Location

Kaiser Permanente Baldwin Park Medical Center

Baldwin Park, California, 91706, United States

Location

Kaiser Permanente Bellflower Medical Center

Bellflower, California, 90706, United States

Location

Kaiser Permanente Fontana Medical Center

Fontana, California, 92335, United States

Location

Marin Cancer Care

Greenbrae, California, 94904, United States

Location

Marin Cancer Center

Greenbrae, California, 94904, United States

Location

Kaiser Permanente Harbor City Medical Center

Harbor City, California, 90710, United States

Location

Kaiser Permanente Irvine Medical Center

Irvine, California, 92618, United States

Location

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

Long Beach Memorial Medical Center - Todd Cancer Institute

Long Beach, California, 90806, United States

Location

Kaiser Permanente Sunset Medical Center

Los Angeles, California, 90027, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Kaiser Permanente Oakland Medical Center

Oakland, California, 94611, United States

Location

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301, United States

Location

Kaiser Permanente Panorama City Medical Center

Panorama City, California, 91402, United States

Location

Kaiser Permanente Riverside Medical Center

Riverside, California, 92505, United States

Location

Kaiser Permanente Roseville Medical Center

Roseville, California, 95661, United States

Location

Kaiser Permanente Sacramento Medical Center

Sacramento, California, 95825, United States

Location

University of California

San Diego, California, 92093, United States

Location

Kaiser Permanente San Diego Medical Center

San Diego, California, 92120, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Kaiser Permanente San Francisco Medical Center

San Francisco, California, 94115, United States

Location

UCSF Helen Diller Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Kaiser Permanente San Jose Medical Center

San Jose, California, 95119, United States

Location

Kaiser Permanente San Leandro Medical Center

San Leandro, California, 94577, United States

Location

Kaiser Permanente San Marcos Medical Center

San Marcos, California, 92078, United States

Location

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California, 95051, United States

Location

Kaiser Permanente South San Francisco Medical Center

South San Francisco, California, 94080, United States

Location

Stanford Women's Cancer Center

Stanford, California, 94305, United States

Location

Kaiser Permanente Vallejo Medical Center

Vallejo, California, 94589, United States

Location

Kaiser Permanente Walnut Creek Medical Center

Walnut Creek, California, 94596, United States

Location

Kaiser Permanente Cadillac Medical Center

West Los Angeles, California, 90034, United States

Location

Kaiser Permanente Woodland Hills Medical Center

Woodland Hills, California, 91367, United States

Location

Western States Cancer Research NCORP

Denver, Colorado, 80222, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Memorial Sloan Cancer Center - Hartford Healthcare Center Institute at HOCC

New Britain, Connecticut, 06053, United States

Location

Christiana Health System - Christiana Hospital

Newark, Delaware, 19718, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

University of Miami Miller School of Medicine Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Advent Health Orlando

Orlando, Florida, 32804, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

Phoebe Putney Memorial Hospital

Albany, Georgia, 31701, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 317404, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Center LAPS

Chicago, Illinois, 60637, United States

Location

Cancer Care Specialist of Central Illinois

Decatur, Illinois, 62526, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

NorthShore University Health System - Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Joliet Oncology Hematology Associates Limited

Joliet, Illinois, 60435, United States

Location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

OSF Saint Anthony Medical Center

Rockford, Illinois, 61108, United States

Location

Orchard Healthcare Research Inc.

Skokie, Illinois, 60017, United States

Location

NorthShore Hematology Oncology-Libertyville

Skokie, Illinois, 60077, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Indiana University - Melvin and Bren Simon Cancer Center LAPS

Indianapolis, Indiana, 46202, United States

Location

IU Health Ball Memorial Hospital

Muncie, Indiana, 47303, United States

Location

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, 50010, United States

Location

McFarland Clinic, P.C.

Ames, Iowa, 50010, United States

Location

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, 52403, United States

Location

Iowa Oncology Research Assoc

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates - Des Moines

Des Moines, Iowa, 50309, United States

Location

Covenant Medical Center

Waterloo, Iowa, 50702, United States

Location

University of Kentucky-Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Norton Cancer Institute - Brownsboro

Louisville, Kentucky, 20202, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Eastern Maine Medical Center d/b/a Northern Light Cancer Institute

Bangor, Maine, 04401, United States

Location

New England Cancer Specialists - Scarborough

Scarborough, Maine, 04074, United States

Location

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

MedStar Good Samaritan Hospital

Baltimore, Maryland, 21218, United States

Location

MedStar Franklin Square Medical Center Winberg Cancer Institute

Baltimore, Maryland, 21237, United States

Location

Medstar Union Memorial Hospital

Baltimore, Maryland, 21237, United States

Location

JHU Sidney Kimmel Comprehensive Cancer Center LAPS

Baltimore, Maryland, 21287, United States

Location

Frederick Regional Health System James M Stockman Cancer Institute

Baltimore, Maryland, 21701, United States

Location

Maryland Oncology Hematology PA

Bethesda, Maryland, 20817, United States

Location

Tidal Health Peninsula Regional

Salisbury, Maryland, 21801, United States

Location

Holy Cross Hospital

Silver Spring, Maryland, 20910, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01852, United States

Location

Beth Israel Deaconess Hospital - Plymouth Jordan Club Cancer Center

Plymouth, Massachusetts, 02360, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Cancer Research Consortium of West Michigan NCORP

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health Butterworth Research Pharmacy

Grand Rapids, Michigan, 49503, United States

Location

Trinity Health Michigan

Livonia, Michigan, 48152, United States

Location

Essentia Health NCORP

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic-Rochester

Rochester, Minnesota, 55902, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, 55416, United States

Location

Metro Minnesota Oncology Research Consortium

Saint Louis Park, Minnesota, 55416, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Phelps Country Regional Medical Center

Rolla, Missouri, 65401, United States

Location

Cancer Research for the Ozarks NCORP

Springfield, Missouri, 65807, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Nebraska Hematology and Oncology

Lincoln, Nebraska, 68506, United States

Location

Southeast Nebraska Cancer Center

Lincoln, Nebraska, 68510, United States

Location

Cancer Alliance of Nebraska

Omaha, Nebraska, 68106, United States

Location

Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

New Hampshire Oncology-Hematology PA, Concord

Concord, New Hampshire, 03301, United States

Location

New Hampshire Oncology-Hematology PA

Hooksett, New Hampshire, 03106, United States

Location

Solinsky Center for Cancer Care

Hooksett, New Hampshire, 03106, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Norris Cotton Cancer Center - Nashua

Lebanon, New Hampshire, 03766, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Rutgers Cancer Center Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, 08876, United States

Location

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Mary Imogene Bassett Hospital

Cooperstown, New York, 11326, United States

Location

Hematology Oncology Associates of Central New York - East Syracuse

East Syracuse, New York, 13057, United States

Location

Queens Hospital Center

Jamaica, New York, 11432, United States

Location

Northwell Health NCORP

New Hyde Park, New York, 11042, United States

Location

Beth Israel Medical Center - New York

New York, New York, 10011, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

Memorial Sloan Kettering Cancer Center - LAPS

New York, New York, 10065, United States

Location

Oneonta FoxCare Center

Oneonta, New York, 13820, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center - Einstein Campus

The Bronx, New York, 10461, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

The Charlotte-Mecklenburg Hospital Authority

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cone Health Cancer Center

Greensboro, North Carolina, 27403, United States

Location

Kinston Medical Specialists, PA

Kinston, North Carolina, 28504, United States

Location

First Health of the Carolinas - Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Cleveland Clinic Cancer Center/Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, 73505, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Hematology & Oncology Associates of Northeastern PA

Dunmore, Pennsylvania, 18512, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC MaGee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh Cancer Institute- Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Reading Hospital/McGlinn Cancer Institute

Wyomissing, Pennsylvania, 19610, United States

Location

WellSpan Health York Cancer Center

York, Pennsylvania, 17403, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Lexington Medical Center/Lexington Oncology Associates

Columbia, South Carolina, 29169, United States

Location

Avera Cancer Institute-Aberdeen

Aberdeen, South Dakota, 57401, United States

Location

Monument Health Rapid City Hospital

Rapid City, South Dakota, 57701, United States

Location

Rapid City Regional Hospital/Regional Cancer Care Institute

Rapid City, South Dakota, 57701, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37204, United States

Location

Nashville General Hospital at Meharry

Nashville, Tennessee, 37208, United States

Location

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Doctors Hospital of Laredo

Laredo, Texas, 78045, United States

Location

Huntsman Cancer Institute - University of Utah

Salt Lake City, Utah, 84112, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

VCU Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

CAMC Cancer Center

Charleston, West Virginia, 25304, United States

Location

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54913, United States

Location

HSHS Saint Vincent Hospital

Green Bay, Wisconsin, 54301, United States

Location

Gunderson Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Wheaton Franciscan Healthcare - St. Joseph

Milwaukee, Wisconsin, 53210, United States

Location

Columbia St. Mary's Water Tower Medical Commons

Milwaukee, Wisconsin, 53711, United States

Location

Wheaton Franciscan Healthcare-All Saints

Racine, Wisconsin, 53405, United States

Location

Orchard Healthcare Research Inc.

Waukesha, Wisconsin, 53188, United States

Location

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States

Location

Wheaton Franciscan Healthcare - Wauwatosa

Wauwatosa, Wisconsin, 53226, United States

Location

Southern Highlands Cancer Centre

Bowral, New South Wales, 2576, Australia

Location

Coffs Harbour Health Campus - MNCCI

Coffs Harbour, New South Wales, 2450, Australia

Location

The Breast & Endocrine Centre

Gateshead, New South Wales, 2290, Australia

Location

Gosford Hospital

Gosford, New South Wales, 2500, Australia

Location

Macquarie University Hospital

Macquarie Park, New South Wales, 2109, Australia

Location

Orange Health Service

Orange, New South Wales, 2800, Australia

Location

Wollongong Hospital

Wollongong, New South Wales, 2500, Australia

Location

Royal Brisbane & Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Flinders Drive

Bedford Park, South Australia, 5042, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

The Northern Hospital

Epping, Victoria, 3076, Australia

Location

St Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

Peninsula Health - Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

University Hospital, Geelong

Geelong, Victoria, 3220, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Peninsula Health - Frankston Hospital

Melbourne, Victoria, Australia

Location

Western Health, Sunshine Hospital

St Albans, Victoria, 3021, Australia

Location

South West Healthcare, Warrnambool

Warrnambool, Victoria, 3280, Australia

Location

St John of God Bunbury Hospital

Bunbury, Western Australia, 6231, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Location

Breast Cancer Research Centre - WA

Nedlands, Western Australia, 6009, Australia

Location

LKH Feldkirch, Department of Internal Medicine

Feldkirch, 6807, Austria

Location

LKH Univ Klinikum Graz, Dept of Internal Med. and Oncology

Graz, 8036, Austria

Location

Medical University of Graz, Gyn. Dept.

Graz, 8036, Austria

Location

University Hospital Innsbruck, Department of Obstetrics and Gynaecology

Innsbruck, 6020, Austria

Location

BKH Kufstein, Innere Medizin

Kufstein, 6330, Austria

Location

LKH Hochsteiermark Leoben

Leoben, 8700, Austria

Location

Hospital of the Sisters of Charity Linz, Surg. Dept., Breast Health Center

Linz, 4010, Austria

Location

Kepler Universitätsklinikum Med. Campus III

Linz, 4020, Austria

Location

Weinviertelklinikum Mistelbach, Department of Surgery

Mistelbach, 2130, Austria

Location

BHS Ried, Abt. f. Gynäkologie

Ried, 4910, Austria

Location

LKH Salzburg, Univ. Klinik f. Innere Med. III

Salzburg, 5020, Austria

Location

Universitätsklinikum St. Pölten, Innere Medizin

Sankt Pölten, 3100, Austria

Location

Breast Centre Dr. Wette Viktor

Sankt Veit an der Glan, 9300, Austria

Location

Phyrn-Eisenwurzen Klinikum Steyr

Steyr, 4400, Austria

Location

Medical University of Vienna Department of Obstetrics and Gynaecology

Vienna, 1090, Austria

Location

Medical University Vienna - Coop Group Surgery/Oncology

Vienna, 1090, Austria

Location

Hospital Hietzing, Gynecology

Vienna, 1130, Austria

Location

St. Josef Krankenhaus, Department of Internal I

Vienna, 1130, Austria

Location

Klinik Ottakring

Vienna, 1160, Austria

Location

Salzkammergut-Klinikum Vöcklabruck

Vöcklabruck, 4840, Austria

Location

Brustordination Dr. Thiel

Weiz, 8160, Austria

Location

Klinikum Wels - Grieskirchen GmbH, Department of Internal Medicine IV

Wels, 4600, Austria

Location

Landesklinikum Wr. Neustadt, Department of Surgery

Wiener Neustadt, 2700, Austria

Location

LKH Wolfsberg, Department of Surgery

Wolfsberg, 9400, Austria

Location

OLV ziekenhuis Aalst/Radiotherapy-Oncology

Aalst, 9300, Belgium

Location

CHU Saint Pierre/Medical Oncology

Brussels, 1000, Belgium

Location

Institut Jules Bordet/Medical Oncology Department

Brussels, 1000, Belgium

Location

Cliniques Universitaires Saint-Luc, Oncologisch centrum

Brussels, 1200, Belgium

Location

Grand Hopital de Charleroi - Oncologie-hématologie

Charleroi, 6000, Belgium

Location

University Hospital Antwerp (UZA)

Edegem, 2650, Belgium

Location

UZ Leuven/ Gynaecologie-Oncologie

Leuven, 3000, Belgium

Location

CHC - Saint-Joseph/Oncology-Hematology

Liège, 4000, Belgium

Location

CHU Sart Tilman Liège (Medical Oncology)

Liège, 4000, Belgium

Location

Clinique et Maternite Sainte-Elisabeth - Oncology Department

Namur, 5000, Belgium

Location

CHR - Centre Hospitalier Peltzer La Tourelle/ Oncology Department

Verviers, 4800, Belgium

Location

GZA Ziekenhuizen (Campus Sint-Augustinus) / Oncologische Centrum

Wilrijk, 2610, Belgium

Location

Tom Baker Cancer Centre - Dept. of Oncology

Calgary, Alberta, T2N4N2, Canada

Location

BC Cancer Agency- Abbotsford Centre

Abbotsford British Columbia, British Columbia, V2S0C2, Canada

Location

BC Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior

Kelowna, British Columbia, V1Y5L3, Canada

Location

BC Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z4E6, Canada

Location

CancerCare Manitoba - St. Boniface Hospital

Winnipeg, Manitoba, R2H2A6, Canada

Location

The Vitalite Health Network - Dr. Leon Richard

Moncton, New Brunswick, E1C8X3, Canada

Location

Horizon Health Network - Saint John Regional Hospital

Saint John, New Brunswick, E2L4L4, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H2Y9, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V5C2, Canada

Location

Kingston General Hospital, Cancer Centre of Southeastern Ontario/Oncology

Kingston, Ontario, K7L5P9, Canada

Location

Grand River Regional Cancer Center

Kitchener, Ontario, N2G1G3, Canada

Location

Niagara Health System

St. Catharines, Ontario, L2S0A9, Canada

Location

Sunnybrook

Toronto, Ontario, M4N3M, Canada

Location

University Health Network Princess Margaret Cancer Centre

Toronto, Ontario, M5G1X5, Canada

Location

The Jewish General Hospital

Montreal, Quebec, H2L4M1, Canada

Location

CHUM Hôtel Dieu

Montreal, Quebec, H2W1T8, Canada

Location

CHU de Québec - Hôpital du St Sacrement

Québec, Quebec, G1S4L8, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T7TI, Canada

Location

Saskatoon Cancer Center, University of Saskatchewan

Saskatoon, Saskatchewan, S7N4H4, Canada

Location

University Hospital Aachen

Aachen, 52074, Germany

Location

Praxisklinik Krebsheilkunde für Frauen

Berlin, 10367, Germany

Location

Helios Klinikum Berlin-Buch

Berlin, 13125, Germany

Location

Studienzentrum City

Berlin, 14169, Germany

Location

Marienhospital Bottrop, Klinik für Gynäkologie und Geburtshilfe

Bottrop, 46236, Germany

Location

Studien GbR Braunschweig, Lorenz&HeckerWesche

Braunschweig, 38100, Germany

Location

Praxis und Tagesklinik für gynäkologische Onkologie,

Ebersberg, 85560, Germany

Location

MVZ Eggenfelden

Eggenfelden, 84307, Germany

Location

Frauenklinik/University Hospital Erlangen

Erlangen, 91054, Germany

Location

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt, 60389, Germany

Location

Agaplesion Markus Krankenhaus

Frankfurt, 60431, Germany

Location

Klinikum Frankfurt Höchst

Frankfurt, 65929, Germany

Location

Onkol. GP Dres. med. Wilke/Wagner/Petzoldt

Fürth, 90766, Germany

Location

Universitätsfrauenklinik Halle (Saale)

Halle, '06120, Germany

Location

University Medical Center Hamburg-Eppendorf, Department of Gynecology

Hamburg, 20246, Germany

Location

Albertinen Krankenhaus

Hamburg, 22457, Germany

Location

Städtisches Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

Elisabeth Krankenhaus Kassel Brustzentrum

Kassel, 34125, Germany

Location

St. Elisabeth Krankenhaus Leipzig

Leipzig, 04277, Germany

Location

St. Vincenz KH Limburg Frauenklinik

Limburg, 65549, Germany

Location

UKSH Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe

Lübeck, 23538, Germany

Location

Universitätsmedizin Mainz

Mainz, 55131, Germany

Location

Praxis Gynäkologie Arabella

München, 81925, Germany

Location

University Clinic Oldenburg

Oldenburg, 26133, Germany

Location

Oncologianova GmbH

Recklinghausen, 45657, Germany

Location

HELIOS Klinik Rottweil - Gynäkologie

Rottweil, 78628, Germany

Location

St. Josefs-Hospital

Wiesbaden, 65189, Germany

Location

Országos Onkológiai Intézet - "B" Belgyógyászati Onkológiai és Klinikai Farmakológiai Osztály

Budapest, 1122, Hungary

Location

Uzsoki Utcai Kórház - Onkoradiológia, Sugárterápia, Fővárosi Onkoradiológiai Központ

Budapest, 1145, Hungary

Location

University of Debrecen Medical Center, Clinic of Oncology

Debrecen, 4032, Hungary

Location

Petz Aladár Megyei Oktatókórház - Onkoradiológiai Osztály

Győr, 9023, Hungary

Location

Szegedi Tudomanyegyetem Általános Orvostudományi Kar Szent-Györgyi Albert Klinikai Központ, Onkoterápiás Klinika

Szeged, 6720, Hungary

Location

Bon Secours Hospital, Cork

Cork, Ireland

Location

Cork University Hospital, Oncology Clinical Trials Unit

Cork, Ireland

Location

Beaumont Hospital - Cancer Clinical Trials Unit

Dublin, Ireland

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

St James's Hospital, Cancer Clinical Trials Office, Old Admin Building,

Dublin, Ireland

Location

St Vincent Hospital - Medical Oncology Research Department

Dublin, Ireland

Location

University Hospital Limerick, Midwestern Cancer Centre

Limerick, Ireland

Location

Sligo University Hospital

Sligo, Ireland

Location

University Hospital Waterford, Cancer Research Department

Waterford, Ireland

Location

Rabin Medical Center (RMC)

Petah Tikva, Central District, 49100, Israel

Location

Sheba Medical Center Tel Hashomer

Ramat Gan, Tel Aviv, 52621, Israel

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, 44124, Italy

Location

Azienda Ospedaliero-Universitaria Careggi/Florence University/Radiation Oncology Unit

Florence, 50134, Italy

Location

Department of Internal Medicine (DIMI) - IRCCS San Martino University Hospital

Genoa, 16132, Italy

Location

P.O. Misericordia AUSL Toscana Sud Est

Grosseto, 58100, Italy

Location

Ospedale "Mater Salutis" di Legnago, Dept. of Medical Oncology

Legnago, 37045, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) IRCCS

Meldola, 47014, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Policlinico di Monza - Istituto di Oncologia del Policlinico di Monza

Monza, 20900, Italy

Location

Medical Oncology Unit; University Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)

Parma, 43100, Italy

Location

Nuovo Ospedale di Prato (NOP) - Azienda USL4 Prato

Prato, 59100, Italy

Location

ASST Bergamo Ovest

Treviglio, 24047, Italy

Location

S. Anna Hospital (Ospedale Sant'Anna)- Turin

Turin, 10126, Italy

Location

Nagoya City University Hospital/Dept. of Breast & Endocrine Surgery

Nagoya, Aichi-ken, 467-8601, Japan

Location

Department of Breast Surgery National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

Location

Chiba Cancer Center

Chiba, 260-8717, Japan

Location

Kyoto University Hospital/Breast Surgery

Kyoto, 606-8507, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, 540-0006, Japan

Location

Osaka International Cancer Institute

Osaka, 541-8567, Japan

Location

Centro Médico Zambrano Hellion

Monterrey, Nuevo León, 66278, Mexico

Location

Centro Oncológico Estatal ISSEMYM

Toluca, Toluca, 50180, Mexico

Location

National Cancer Institute Mexico, Breast Cancer Department

Mexico City, 14080, Mexico

Location

Máxima Medisch Centrum

Eindhoven, 5631 BM, Netherlands

Location

Zuyderland Ziekenhuis, Oncology

Geleen, 6162 BG, Netherlands

Location

St Antonius Hospital

Nieuwegein, 3435 CM, Netherlands

Location

Hagaziekenhuis

The Hague, 2545 AA, Netherlands

Location

Zaans Medical Center

Zaandam, 1502 DV, Netherlands

Location

Isala, Dept of Medical Oncology

Zwolle, 8025 AB, Netherlands

Location

Uniwersyteckie Centrum Kliniczne (UCK), Klinika Onkologii I Radioterapii

Gdansk, 80-952, Poland

Location

Instytut MSF Spółka z ograniczoną odpowiedzialnością

Lodz, Poland

Location

Opolskie Centrum Onkologii, Oddzial Onkologii Klinicznej

Opole, 45-001, Poland

Location

Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie

Warsaw, 02-781, Poland

Location

Instituto Português de Oncologia (IPO) de Lisboa Francisco Gentil

Lisbon, 1099-023, Portugal

Location

Centro Clinico Champalimaud

Lisbon, 1400-038, Portugal

Location

Hospital da Luz

Lisbon, 1500-650, Portugal

Location

CUF Descobertas Hospital, Hemato-Oncologia

Lisbon, 1998-018, Portugal

Location

Instituto Português de Oncologia (IPO) Francisco Gentil do Porto

Porto, 4200, Portugal

Location

Seoul National University Hospital, Hematology-Medical Oncology

Seoul, 03080, South Korea

Location

Severance Hospital Medical Doctor at Department of Medical Oncology

Seoul, 03722, South Korea

Location

Samsung Medical Centre, Breast Cancer Center, Department of Medicine, Division of Hematology/Oncology

Seoul, 06351, South Korea

Location

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, 15006, Spain

Location

Centro Oncologico de Galicia

A Coruña, 15009, Spain

Location

Hospital General Universitario Alicante

Alicante, 03010, Spain

Location

ICO Badalona

Badalona, 08916, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Quirón Dexeus

Barcelona, 08028, Spain

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Hospital General de Granollers

Barcelona, 08402, Spain

Location

Instituto Catalán de Oncología (ICO) de L'Hospitalet de Llobregat

Barcelona, 08908, Spain

Location

Hospital Vall d´Hebron

Barcelona, 8035, Spain

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Consorcio Hospitalario Provincial de Castellon

Castellon, 12002, Spain

Location

San Pedro de Alcántara

Cáceres, 10003, Spain

Location

Hospital Reina Sofía

Córdoba, 14004, Spain

Location

Hospital General Universitario de Elche

Elche, 03203, Spain

Location

ICO/ H. Josep Trueta

Girona, 17007, Spain

Location

Complejo asistencial universitario de Leon

León, 24001, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

MD Anderson Cancer Center

Madrid, 28033, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital La Paz, Servicio de Oncologia Médica

Madrid, 28046, Spain

Location

CIOCC - Centro Integral Oncológico Clara Campal / Hospital HM Universitario Sanchinarro

Madrid, 28050, Spain

Location

Hospital Puerta de Hierro Majadahonda, Oncologia Médica

Madrid, 28222, Spain

Location

Hospital Universitario Fundacion Alcorcón

Madrid, 28922, Spain

Location

Hospital Clínico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital General Universitario José Mª Morales Meseguer

Murcia, 30008, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospitali Universitari son Espases

Palma, 07120, Spain

Location

Hospital Son Llatzer

Palma, 07198, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitari Sant Joan de Reus

Reus, 43204, Spain

Location

Hospital Universitario Donostia

San Sebastián, 20014, Spain

Location

Hospital de Sant Juan Despi Moisés Broggi

Sant Joan Despì, 08970, Spain

Location

Hospital Clinico Universitario de Santiago

Santiago, 15706, Spain

Location

Hospital Unversitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Quirón Sagrado Corazón

Seville, 41013, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, 08227, Spain

Location

Hospital Virgen de la Salud

Toledo, 45004, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hosital Arnau de Vilanova Valencia

Valencia, 46015, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Gävle Hospital, Dept. of Oncology

Gävle, 801 87, Sweden

Location

Sahlgrenska University Hospital, Dept. Oncology

Gothenburg, 413 45, Sweden

Location

Universitetssjukhuset Örebro (University Hospital) Örebro, Onkologkliniken

Örebro, 701 85, Sweden

Location

Karolinska Universitetssjukhuset, Bröstcentrum A2:00

Stockholm, 171 76, Sweden

Location

Akademiska Sjukhuset Uppsala (University Hospital), Onkologkliniken

Uppsala, 751 85, Sweden

Location

Kantonspital Baden

Baden, Canton of Aargau, 5404, Switzerland

Location

Spital STS AG, Onkologiezentrum Thun-Berner Oberland

Thun, Canton of Bern, 3600, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, 1211, Switzerland

Location

IOSI-Breast Cancer Unit-Ospedale San Giovanni-Bellinzona

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Fondazione Oncologia Lago Maggiore, Locarno

Locarno, Canton Ticino, 6600, Switzerland

Location

Kantonsspital Graubünden

Chur, Kanton Graubünden, 7000, Switzerland

Location

Dep. Oncology, University Hospital

Basel, 4031, Switzerland

Location

HFR Fribourg, Oncology Department

Fribourg, 1708, Switzerland

Location

Luzerner Kantonsspital, Dept. of Medical Oncology

Lucerne, 6000, Switzerland

Location

Onkologisches Forschungszentrum Klinik St. Anna, Hirslanden

Lucerne, 6006, Switzerland

Location

Kantonsspital St.Gallen, Onkologie/Hämatologie

Sankt Gallen, 9007, Switzerland

Location

Brust-Zentrum Zürich

Zurich, 8008, Switzerland

Location

Universitätsspital Zürich, Klinik für Onkologie

Zurich, 8091, Switzerland

Location

Changhua Christian Hospital/General Surgery

Changhua, Changhua County, 500, Taiwan

Location

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

National Cheng Kung University Hospital, Division of Hemato-Oncology, Dept. Internal Medicine

Tainan, 704, Taiwan

Location

National Taiwan University Hospital/Department of Surgery

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital/General Surgery

Taipei, 112, Taiwan

Location

City Hospital Birmingham

Birmingham, B18 7QH, United Kingdom

Location

University Hospitals Bristol NHS Foundation Trust

Bristol, BS2 8ED, United Kingdom

Location

Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

Location

Royal Marsden Hospital Chelsea

Chelsea, SW3 6JJ, United Kingdom

Location

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

University Hospitals of Leicester

Leicester, LE1 5WW, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

The Royal Marsden Sutton

London, SW3 6JJ, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF UK, United Kingdom

Location

Maidstone Hospital, Kent Oncology Centre

Maidstone, ME16 9QQ, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Northern Centre for Cancer Care

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Nottingham University Hospitals NHS TRUST UK

Nottingham, NG5 1PB, United Kingdom

Location

Weston Park Hospital, Sheffield Teaching Hospitals

Sheffield, S10 2SJ, United Kingdom

Location

Royal Cornwall Hospitals NHS Trust, Oncology Trials, Sunrise Centre

Truro, TR1 3LQ, United Kingdom

Location

Related Publications (7)

  • Shinn E, Zahrieh D, DeMichele A, Zdenkowski N, Lemieux J, Mao J, Bjelic-Radisic V, Naughton MJ, Pfeiler G, Gelmon K, Balko JM, Egle D, Zoppoli G, Traina T, Jimenez MM, Novoa SA, Haddad T, Chan A, Ring A, Wolff A, Symmans WF, Ponce Lorenzo J, Sabanathan D, Burstein HJ, Nowecki ZI, Pristauz-Telsnigg G, Brufsky A, Bellet-Ezquerra M, Foukakis T, Novik Y, Rubovszky G, Singer CF, Muehlbacher K, Filho OM, Goulioti T, Law E, Partridge AH, Carey LA, Zoroufy A, Hlauschek D, Fesl C, Mayer EL, Gnant M. Impact of adding palbociclib on treatment adherence to ongoing adjuvant endocrine treatment in the global randomized PALLAS randomized trial in patients with early breast cancer. Breast Cancer Res Treat. 2025 Jun;211(2):385-397. doi: 10.1007/s10549-025-07653-2. Epub 2025 Mar 27.

  • DeMichele A, Dueck AC, Hlauschek D, Martin M, Burstein H, Pfeiler G, Zdenkowski N, Wolff A, Bellet-Ezquerra M, Winer E, Balic M, Miller K, Colleoni M, Lake D, Rubovsky G, Cameron D, Balko J, Singer CF, Nowecki Z, Iwata H, Wolmark N, Parraga KA, Rugo H, Steger GG, Traina T, Werutsky G, Czajkowska D, Metzger O, El-Abed S, Theall KP, Lu RD, O'Brien P, Fesl C, Mayer E, Gnant M. Outcomes in stage IIA versus stage IIB/III in the PALLAS trial [ABCSG-42/AFT-05/PrE0109/BIG-14-13]). Breast Cancer Res. 2025 Jan 23;27(1):12. doi: 10.1186/s13058-024-01941-3.

  • Pfeiler G, Hlauschek D, Mayer EL, Deutschmann C, Kacerovsky-Strobl S, Martin M, Meisel JL, Zdenkowski N, Loibl S, Balic M, Park H, Prat A, Isaacs C, Bajetta E, Balko JM, Bellet-Ezquerra M, Bliss J, Burstein H, Cardoso F, Fohler H, Foukakis T, Gelmon KA, Goetz M, Haddad TC, Iwata H, Jassem J, Lee SC, Linderholm B, Los M, Mamounas EP, Miller KD, Morris PG, Munzone E, Gal-Yam EN, Ring A, Shepherd L, Singer C, Thomssen C, Tseng LM, Valagussa P, Winer EP, Wolff AC, Zoppoli G, Machacek-Link J, Schurmans C, Huang X, Gauthier E, Fesl C, Dueck AC, DeMichele A, Gnant M; PALLAS Groups and Investigators. Impact of BMI in Patients With Early Hormone Receptor-Positive Breast Cancer Receiving Endocrine Therapy With or Without Palbociclib in the PALLAS Trial. J Clin Oncol. 2023 Nov 20;41(33):5118-5130. doi: 10.1200/JCO.23.00126. Epub 2023 Aug 9.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Erica L. Mayer, MD, MPH
Organization
Dana-Farber Cancer Institute

Study Officials

  • Evanthia Galanis, MD

    Alliance Foundation Trials, LLC.

    PRINCIPAL INVESTIGATOR
  • Erica Mayer, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR
  • Angela DeMichele, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
  • Michael Gnant, MD

    ABCSG, Medical University Vienna

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2015

First Posted

July 31, 2015

Study Start

August 1, 2015

Primary Completion

November 1, 2020

Study Completion (Estimated)

December 1, 2028

Last Updated

February 10, 2026

Results First Posted

April 13, 2022

Record last verified: 2025-01

Locations