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 |
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.
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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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1211 Medical Center Dr
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Nashville, Tennessee 37232
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Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Emory University Hospital As the largest health care system in Georgia and the only health...
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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401 North Broadway
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Baltimore, Maryland 21287
410-955-5000
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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1801 West Taylor, Suite 1E
Chicago, Illinois 60612
Chicago, Illinois 60612
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University of Illinois Cancer Center The University of Illinois Cancer Center is dedicated to reducing...
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18200 Lorain Avenue
Cleveland, Ohio 44111
Cleveland, Ohio 44111
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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8505 Arlington Boulevard
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Fairfax, Virginia 22031
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
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Cone Health Cancer Center Located adjacent to Wesley Long Hospital, our Cone Health Cancer Center...
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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lowell General Hospital Welcome to Lowell General Hospital! Our goal is to provide you with...
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1475 NW 12th Ave
Miami, Florida 33136
Miami, Florida 33136
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University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
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1660 Springhill Avenue
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University of South Alabama Mitchell Cancer Institute USA Mitchell Cancer Institute (MCI) is located in...
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183 North Mountain Road
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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