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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/13/2019
Start Date:August 2015
End Date:September 2025

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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.


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).
We found this trial at
162
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6780 Mayfield Rd
Mayfield Heights, Ohio 44124
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185 Cambridge Street
Boston, Massachusetts 02114
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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330 Brookline Ave
Boston, Massachusetts 02215
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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666 Elm Street
Buffalo, New York 14263
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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Aberdeen, South Dakota 57401
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Albuquerque, New Mexico 87131
(505) 277-0111
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Ames, Iowa 50010
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Anchorage, Alaska 99508
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3200 Providence Drive
Anchorage, Alaska 99508
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2006 Hogback Road
Ann Arbor, Michigan 48106
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Annapolis, Maryland 21401
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Appleton, Wisconsin 54915
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Baltimore, Maryland 21237
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
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Baltimore, Maryland 21218
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Baltimore, Maryland 21287
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489 State St
Bangor, Maine 04401
(207) 973-7000
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6420 Rockledge Drive
Bethesda, Maryland 20817
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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Bowral, New South Wales 2576
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3415 MacCorkle Avenue Southeast
Charleston, West Virginia 25304
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Charlotte, North Carolina 28203
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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1801 West Taylor, Suite 1E
Chicago, Illinois 60612
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Clearwater, Florida 33756
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18200 Lorain Avenue
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Columbia, South Carolina 29169
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Concord, New Hampshire 03301
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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350 Engle St
Englewood, New Jersey 07631
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8505 Arlington Boulevard
Fairfax, Virginia 22031
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
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835 S Van Buren St
Green Bay, Wisconsin 54301
(920) 433-0111
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Greenbrae, California 94904
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501 N. Elam Avenue
Greensboro, North Carolina 27403
336-832-1100
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Hackensack, New Jersey 07601
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
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Hooksett, New Hampshire 03106
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
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6550 Fannin St
Houston, Texas 77030
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Jacksonville, Florida 32216
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Jamaica, New York 11432
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Kansas City, Missouri 64111
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1900 South Avenue
La Crosse, Wisconsin 54601
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La Jolla, California 92093
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555 N Duke St
Lancaster, Pennsylvania 17602
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Laredo, Texas 78041
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Lebanon, New Hampshire 03756
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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Livonia, Michigan 48152
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Louisville, Kentucky 40207
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295 Varnum Ave
Lowell, Massachusetts 01854
(978) 937-6000
Lowell General Hospital Welcome to Lowell General Hospital! Our goal is to provide you with...
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Madison, Wisconsin 53792
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1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
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Miami Beach, Florida 33140
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Milwaukee, Wisconsin 53211
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Milwaukee, Wisconsin 53210
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Mobile, Alabama 36608
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1660 Springhill Avenue
Mobile, Alabama 36604
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Muncie, Indiana 47303
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Nashville, Tennessee 37208
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183 North Mountain Road
New Britain, Connecticut 06053
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New Hyde Park, New York 11042
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New Orleans, Louisiana 70121
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550 1st Ave
New York, New York 10016
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1275 York Ave
New York, New York 10021
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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