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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 (PALLAS)

This study is currently recruiting participants.
Verified September 2017 by Alliance Foundation Trials, LLC.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02513394
First Posted: July 31, 2015
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Austrian Breast & Colorectal Cancer Study Group
NSABP Foundation Inc
PrECOG, LLC.
Breast International Group
Pfizer
Information provided by (Responsible Party):
Alliance Foundation Trials, LLC.
  Purpose

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.


Condition Intervention Phase
Breast Cancer Drug: Palbociclib Drug: Standard Adjuvant Endocrine Therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alliance Foundation Trials, LLC.:

Primary Outcome Measures:
  • Invasive Disease Free Survival (iDFS) [ Time Frame: The expected study duration to primary analysis of iDFS is 4.8 years ]
    To compare 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).


Secondary Outcome Measures:
  • To compare the safety of 2 years of palbociclib with adjuvant endocrine therapy versus adjuvant endocrine therapy alone. (distant recurrence-free survival (DRFS), locoregional recurrences-free survival (LRRFS), and overall survival (OS) [ Time Frame: The expected study duration to primary analysis of iDFS is 4.8 years ]
    To compare the following endpoints: iDFS excluding second primary cancers of non-breast origin, distant recurrence-free survival (DRFS), locoregional recurrences-free survival (LRRFS), and overall survival (OS).


Estimated Enrollment: 4600
Study Start Date: August 2015
Estimated Study Completion Date: September 2025
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
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: Palbociclib Drug: Standard Adjuvant Endocrine Therapy
Arm B
Standard adjuvant endocrine therapy for a duration of at least 5 years.
Drug: Standard Adjuvant Endocrine Therapy

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 within normal institutional limits 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 (for exceptions see: Pallas -

  • Protocol, v1.0, Exclusion criteria 8).
  • Patients who previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy.
  • Patients on combination antiretroviral therapy.
  • Patients with clinically significant history of any liver disease.
  • Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen therapy is allowable).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513394


Contacts
Contact: Edward Habermehl info@alliancefoundationtrials.org

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama Mitchell Cancer Institute Recruiting
Mobile, Alabama, United States, 36604
Southern Cancer Center Recruiting
Mobile, Alabama, United States, 36608
United States, Alaska
Katmai Oncology Group Recruiting
Anchorage, Alaska, United States, 99508
Providence Alaska Cancer Center Recruiting
Anchorage, Alaska, United States, 99508
United States, Arizona
Mayo Clinic - Arizona Recruiting
Phoenix, Arizona, United States, 85054
United States, California
Marin Cancer Care Recruiting
Greenbrae, California, United States, 94904
Marin Cancer Center Recruiting
Greenbrae, California, United States, 94904
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Kaiser Permanente Oakland Medical Center Recruiting
Oakland, California, United States, 94611
Palo Alto Medical Foundation Recruiting
Palo Alto, California, United States, 94301
Kaiser Permanente Roseville Medical Center Recruiting
Roseville, California, United States, 95661
Kaiser Permanente Sacramento Medical Center Recruiting
Sacramento, California, United States, 95825
University of California Recruiting
San Diego, California, United States, 92093
Kaiser Permanente Zion Medical Center Recruiting
San Diego, California, United States, 92120
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Naval Medical Center Withdrawn
San Diego, California, United States, 92134
Kaiser Permanente San Francisco Medical Center Recruiting
San Francisco, California, United States, 94115
UCSF Mount Zion Recruiting
San Francisco, California, United States, 94115
Kaiser Permanente San Leandro Recruiting
San Leandro, California, United States, 94577
Kaiser Permanente Santa Clara Medical Center Recruiting
Santa Clara, California, United States, 95051
Kaiser Permanente South San Francisco Medical Center Recruiting
South San Francisco, California, United States, 94080
Stanford Hospital and Clinics Recruiting
Stanford, California, United States, 94305
Kaiser Permanente Vallejo Medical Center Recruiting
Vallejo, California, United States, 94589
Kaiser Permanente Walnut Creek Medical Center Recruiting
Walnut Creek, California, United States, 94596
United States, Colorado
Colorado Cancer Research Program Recruiting
Denver, Colorado, United States, 80222
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Memorial Sloan Cancer Center - Hartford Healthcare Center Institute at HOCC Recruiting
New Britain, Connecticut, United States, 06053
United States, Delaware
Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19718
United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, D.C., District of Columbia, United States, 20007
George Washington University Medical Center Recruiting
Washington, D.C., District of Columbia, United States, 20037
United States, Florida
Morton Plant Mease Recruiting
Clearwater, Florida, United States, 33756
Mayo Clinic-Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Mount Sinai Comprehensive Cancer Center Recruiting
Miami Beach, Florida, United States, 33140
University of Miami Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Cancer Institute of Florida Recruiting
Orlando, Florida, United States, 32804
United States, Georgia
Phoebe Putney Memorial Hospital Withdrawn
Albany, Georgia, United States, 31701
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 317404
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Cancer Care Specialist of Central Illinois Recruiting
Decatur, Illinois, United States, 62526
Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Joliet Oncology Hematology Associates Recruiting
Joliet, Illinois, United States, 60435
Advocate Lutheran General Hospital Recruiting
Park Ridge, Illinois, United States, 60068
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
OSF Saint Anthony Medical Center Recruiting
Rockford, Illinois, United States, 61108
Orchard Healthcare Research Inc. Recruiting
Skokie, Illinois, United States, 60017
NorthShore Hematology Oncology-Libertyville Recruiting
Skokie, Illinois, United States, 60077
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
IU Health Ball Memorial Hospital Recruiting
Muncie, Indiana, United States, 47303
United States, Iowa
McFarland Clinic PC-William R Bliss Recruiting
Ames, Iowa, United States, 50010
McFarland Clinic, P.C. Recruiting
Ames, Iowa, United States, 50010
Physicians' Clinic of Iowa PC-Hematology and Oncology Recruiting
Cedar Rapids, Iowa, United States, 52403
Iowa Oncology Research Assoc Recruiting
Des Moines, Iowa, United States, 50309
Covenant Cancer Treatment Center Recruiting
Waterloo, Iowa, United States, 50702
United States, Kentucky
University of Kentucky-Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 20202
United States, Louisiana
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
New England Cancer Specialists Recruiting
Scarborough, Maine, United States, 04074
United States, Maryland
Anne Arundel Medical Center Recruiting
Annapolis, Maryland, United States, 21401
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
MedStar Franklin Square Medical Center Recruiting
Baltimore, Maryland, United States, 21237
Medstar Union Memorial Hospital Recruiting
Baltimore, Maryland, United States, 21237
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Frederick Memorial Hospital Recruiting
Baltimore, Maryland, United States, 21701
Maryland Oncology Hematology PA Recruiting
Bethesda, Maryland, United States, 20817
Peninsula Regional Medical Center Recruiting
Salisbury, Maryland, United States, 21801
Holy Cross Hospital Recruiting
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Lowell General Hospital Recruiting
Lowell, Massachusetts, United States, 01852
Beth Israel Deaconess Medical Center PLYMOUTH Recruiting
Plymouth, Massachusetts, United States, 02360
United States, Michigan
Saint Joseph Mercy Health System Recruiting
Ann Arbor, Michigan, United States, 48106
Spectrum Health Butterworth Research Pharmacy Recruiting
Grand Rapids, Michigan, United States, 49503
Trinity Health Michigan Recruiting
Livonia, Michigan, United States, 48152
United States, Minnesota
Essentia Health Recruiting
Duluth, Minnesota, United States, 55805
Mayo Clinic-Rochester Recruiting
Rochester, Minnesota, United States, 55902
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Coborn Cancer Center Recruiting
Saint Cloud, Minnesota, United States, 56303
Metro Minnesota Oncology Research Consortium Recruiting
Saint Louis Park, Minnesota, United States, 55416
Metro MN Community Oncology Research Consortium Recruiting
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
St. Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Phelps Country Regional Medical Center Recruiting
Rolla, Missouri, United States, 65401
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Missouri Baptist Cancer Center Recruiting
Saint Louis, Missouri, United States, 63131
Mercy Hospital Recruiting
Saint Louis, Missouri, United States, 63141
Cancer Research for the Ozarks Recruiting
Springfield, Missouri, United States, 65807
United States, Nebraska
Missouri Valley Cancer Consortium Recruiting
Omaha, Nebraska, United States, 68106
United States, New Hampshire
New Hampshire Oncology-Hematology PA Recruiting
Concord, New Hampshire, United States, 03301
New Hampshire Oncology-Hematology PA Recruiting
Hooksett, New Hampshire, United States, 03106
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Norris Cotton Cancer Center Recruiting
Lebanon, New Hampshire, United States, 03766
United States, New Jersey
Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Hackensack Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
United States, New Mexico
University of New Mexico Comprehensive Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Bassett Healthcare Network Recruiting
Cooperstown, New York, United States, 11326
Hematology Oncology Associates of Central New York, PC Recruiting
East Syracuse, New York, United States, 13057
Queens Cancer Center of Queens Hospital Recruiting
Jamaica, New York, United States, 11432
Monter Cancer Center Recruiting
New Hyde Park, New York, United States, 11042
Mount Sinai Beth Israel Comprehensive Cancer Center Recruiting
New York, New York, United States, 10011
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Oneonta FoxCare Center Recruiting
Oneonta, New York, United States, 13820
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Montefiore Medical Center Recruiting
The Bronx, New York, United States, 10461
United States, North Carolina
The Charlotte-Mecklenburg Hospital Authority Recruiting
Charlotte, North Carolina, United States, 28204
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Cone Health Cancer Center Recruiting
Greensboro, North Carolina, United States, 27403
Kinston Medical Specialists Withdrawn
Kinston, North Carolina, United States, 28504
First Health of the Carolinas Recruiting
Pinehurst, North Carolina, United States, 28374
United States, North Dakota
Rapid City Regional Hospital/Regional Cancer Care Institute Recruiting
Rapid City, North Dakota, United States, 57701
United States, Ohio
Cleveland Clinic Cancer Center/Fairview Hospital Moll Pavilion Recruiting
Cleveland, Ohio, United States, 44111
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Cleveland Clinic Cancer Center/Hillcrest Hospital Recruiting
Mayfield Heights, Ohio, United States, 44124
United States, Oklahoma
Cancer Centers of Southwest Oklahoma Recruiting
Lawton, Oklahoma, United States, 73505
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
University of Oklahoma Health Sciences Center Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Providence Oncology & Hematology Care Clinic - Eastside Recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
Hematology & Oncology Associates of Northeastern PA Recruiting
Dunmore, Pennsylvania, United States, 18512
Penn State Milton S Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17604
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19106
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Cancer Institute- Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Reading Hospital Recruiting
Wyomissing, Pennsylvania, United States, 19610
WellSpan Health-York Hospital Recruiting
York, Pennsylvania, United States, 17403
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Women & Infants Hospital of Rhode Island Recruiting
Providence, Rhode Island, United States, 02905
United States, South Carolina
Lexington Medical Center Recruiting
Columbia, South Carolina, United States, 29169
United States, South Dakota
Avera Cancer Institute-Aberdeen Recruiting
Aberdeen, South Dakota, United States, 57401
Rapid City Regional Hospital Recruiting
Rapid City, South Dakota, United States, 57701
Avera Cancer Institute-Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37204
Meharry Medical College Recruiting
Nashville, Tennessee, United States, 37208
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Doctors Hospital of Laredo Not yet recruiting
Laredo, Texas, United States, 78045
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
United States, Virginia
Inova (Medical Oncology and Hematology of Northern Virginia) Recruiting
Fairfax, Virginia, United States, 22031
VCU Massey Cancer Center Dalton Oncology Clinic Recruiting
Richmond, Virginia, United States, 23298
United States, West Virginia
CAMC Cancer Center Recruiting
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Fox Valley Hematology and Oncology Recruiting
Appleton, Wisconsin, United States, 54913
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Gunderson Health System Recruiting
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital Recruiting
Madison, Wisconsin, United States, 53792
Wheaton Franciscan Healthcare - St. Joseph Recruiting
Milwaukee, Wisconsin, United States, 53210
Columbia St. Mary's Recruiting
Milwaukee, Wisconsin, United States, 53711
Wheaton Franciscan Healthcare-All Saints Recruiting
Racine, Wisconsin, United States, 53405
Orchard Healthcare Research Inc. Recruiting
Waukesha, Wisconsin, United States, 53188
ProHealth Waukesha Recruiting
Waukesha, Wisconsin, United States, 53188
Australia, New South Wales
Southern Highlands Cancer Centre Recruiting
Bowral, New South Wales, Australia
Coffs Harbour Health Campus - MNCCI Recruiting
Coffs Harbour, New South Wales, Australia
The Breast & Endocrine Centre Recruiting
Gateshead, New South Wales, Australia
CCLHD/Gosford & Wyong Hospitals Recruiting
Gosford, New South Wales, Australia
Orange Health Service Recruiting
Orange, New South Wales, Australia
Macquarie University Hospital Recruiting
Sydney, New South Wales, Australia
Wollongong Hospital Recruiting
Wollongong, New South Wales, Australia
Australia, Queensland
Cancer Care Services, Royal Brisbane and Women's Hospital Recruiting
Brisbane, Queensland, Australia
Australia, South Australia
Flinders Medical Centre Not yet recruiting
Bedford Park, South Australia, Australia
Australia, Tasmania
Royal Hobart Hospital Recruiting
Hobart, Tasmania, Australia
Australia, Victoria
The Northern Hospital Recruiting
Epping, Victoria, Australia
St Vincent's Hospital Cancer Centre Recruiting
Fitzroy, Victoria, Australia
Barwon Health Recruiting
Geelong, Victoria, Australia
Peninsula Health - Frankston Hospital Recruiting
Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia
Western Health, Sunshine Hospital Recruiting
St. Albans, Victoria, Australia
South West Oncology Recruiting
Warrnambool, Victoria, Australia
Australia, Western Australia
St John of God Bunbury Hospital Recruiting
Bunbury, Western Australia, Australia
Fiona Stanley Hospital Recruiting
Murdoch, Perth, Western Australia, Australia
Breast Cancer Research Centre Recruiting
Perth, Western Australia, Australia
Canada, Alberta
Tom Baker Cancer Centre Not yet recruiting
Calgary, Alberta, Canada, T2N4N2
Canada, British Columbia
BC Cancer Agency- Abbotsford Centre Not yet recruiting
Abbotsford, British Columbia, Canada, V2S0C2
BC Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior Not yet recruiting
Kelowna, British Columbia, Canada, V1Y5L3
Canada, Manitoba
CancerCare Manitoba - St. Boniface Hospital Not yet recruiting
Winnipeg, Manitoba, Canada, R2H2A6
Canada, New Brunswick
The Vitalite Health Network Not yet recruiting
Moncton, New Brunswick, Canada, E1C8X3
Horizon Health Network - Saint John Regional Hospital Not yet recruiting
Saint John, New Brunswick, Canada, E2L4L4
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3H2Y9
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V5C2
Cancer Centre of Southeastern Ontario Not yet recruiting
Kingston, Ontario, Canada, K7L5P9
Grand river regional cancer center, clinical trials Recruiting
Kitchener, Ontario, Canada, N2G1G3
Niagara Health System - St. Catharines Not yet recruiting
St. Catharines, Ontario, Canada, L2S0A9
Sunnybrook Hospital Not yet recruiting
Toronto, Ontario, Canada, M4N3M
Princess Margaret Hospital (PMH), University Health Network (UHN) Princess Margret Cancer Centre Not yet recruiting
Toronto, Ontario, Canada, M5G1X5
Canada, Quebec
Jewish General Hospital Not yet recruiting
Montréal, Quebec, Canada, H2L4M1
CHUM - Hôtel-Dieu de Montréal Not yet recruiting
Montréal, Quebec, Canada, H2W1T8
McGill University Health Center Not yet recruiting
Montréal, Quebec, Canada, H3A1A1
CHU de Québec - Hôpital du St Sacrement Recruiting
Québec, Quebec, Canada, G1S4L8
CHUS, Hôpital Fleurimont Not yet recruiting
Sherbrooke, Quebec, Canada, J1H5N4
Canada, Saskatchewan
Saskatoon Cancer Center, University of Saskatchewan Not yet recruiting
Saskatoon, Saskatchewan, Canada, S7N4H4
Israel
Rabin Medical Center (RMC) Recruiting
Petah Tikva, Central, Israel
Sheba Medical Center Tel Hashomer Recruiting
Ramat Gan, Tel Aviv, Israel
Sourasky Medical Center Recruiting
Tel Aviv, Israel
Korea, Republic of
Yonsei University, Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Seoul National Univ. Hospital (SNUH), Cancer Hospital Not yet recruiting
Seoul, Korea, Republic of, 110744
Samsung Medical Centre (SMC) Not yet recruiting
Seoul, Korea, Republic of, 135710
Mexico
Hospital San José Tec de Monterrey Not yet recruiting
Monterrey, Nuevo León, Mexico, 66278
Centro Oncológico Estatal ISSEMyM Not yet recruiting
Toluca de Lerdo, Toluca, Mexico, 50180
National Cancer Institute Mexico (Instituto Nacional de Cancerología) Not yet recruiting
Mexico, Mexico, 14080
Switzerland
Kantonspital Baden Not yet recruiting
Baden, Aargau, Switzerland, 5404
Spital STS AG, Onkologiezentrum Thun-Berner Oberland Recruiting
Thun, Bern, Switzerland
Hôpitaux Universitaires de Genève Recruiting
Genève, Geneva, Switzerland
Kantonsspital Graubünden Recruiting
Chur, Graubünden, Switzerland
Ospedale San Giovanni-Bellinzona, IOSI-Breast Cancer Unit Recruiting
Bellinzona, Tessin, Switzerland
Fondazione Oncologia Lago Maggiore Not yet recruiting
Locarno, Tessin, Switzerland, 6600
University Hospital Recruiting
Basel, Switzerland
HFR Fribourg Not yet recruiting
Fribourg, Switzerland, 1708
Luzerner Kantonsspital Recruiting
Luzern, Switzerland
Kantonsspital St.Gallen Recruiting
St.Gallen, Switzerland
Universitätsspital Zürich Not yet recruiting
Zurich, Switzerland, 8091
Brust-Zentrum Zürich Recruiting
Zurich, Switzerland
Taiwan
Changhua Christian Hospital Not yet recruiting
Changhua, Changhua County, Taiwan, 500
Kaohsiung Medical University Hospital Not yet recruiting
Kaohsiung, Taiwan, 807
National Cheng Kung University Hospital Not yet recruiting
Tainan, Taiwan
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 100
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Sponsors and Collaborators
Alliance Foundation Trials, LLC.
Austrian Breast & Colorectal Cancer Study Group
NSABP Foundation Inc
PrECOG, LLC.
Breast International Group
Pfizer
Investigators
Principal Investigator: Monica Bertagnolli, 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
  More Information

Responsible Party: Alliance Foundation Trials, LLC.
ClinicalTrials.gov Identifier: NCT02513394     History of Changes
Other Study ID Numbers: AFT-05
ABCSG 42 ( Other Identifier: ABCSG GmbH )
BIG 14-03 ( Other Identifier: Breast International Group )
2014-005181-30 ( EudraCT Number )
First Submitted: July 29, 2015
First Posted: July 31, 2015
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by Alliance Foundation Trials, LLC.:
HR+/HER2- breast cancer
Palbociclib

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Mitogens
Palbociclib
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors