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Protocol No. UW15128

Principal Investigator ORegan, Ruth

Phase III

Age Group Adult

Scope National

Sponsor Type Industry

Title PALLAS: 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)

Objective The purpose of this study is to compare any good and bad effects of using two years of Palbociclib in combination with standard anti-hormone therapy to using standard anti-hormone therapy alone and to evaluate the likelihood that invasive breast cancer returns.

Treatment Palbociclib is a drug that may stop cancer cells from growing. Palbociclib blocks activity of two closely related enzymes (proteins that help chemical reactions occur in the body), called Cyclin D Kinases 4 and 6 (CDK 4/6). These proteins are part of a pathway, or a sequence of steps, which is known to regulate cell growth. Laboratory testing has suggested Palbociclib may stop the growth of HR+ breast cancer.

Description This study group has two study groups known as Arms. A computer will assign you to one of the two groups in the study. You and the study doctor will know what drugs you have been assigned. If you are in Arm A, you will take your anti-hormone therapy, as ordered by your study doctor, for at least 5 years. You will also take Palbociclib (by mouth) every day for 21 days, with 7 days off, for each 28 day cycle. You will take Palbociclib for 2 years. If you are on Arm B, you will take your anti-hormone therapy, as ordered by your study doctor, for at least 5 years.

Key Eligibility
  • Premenopausal and postmenopausal women or men with Stage II (Stage IIA limited to a maximum of 1000 patients) or Stage III early invasive breast cancer
  • If neoadjuvant systemic therapy was received (either chemotherapy or endocrine therapy), either initial clinical stage (determined by physical and/or radiologic examination) or post-operative pathologic stage can be used for eligibility purposes, with the higher stage determining eligibility
  • Patients with multicentric and/or multifocal and/or bilateral early invasive breast cancer whose histopathologically examined tumors all meet pathologic criteria for ER+ and/or PR+ and HER2-
  • Patients must have histologically confirmed hormone receptor positive (ER+ and/or PR+), HER2-, early invasive breast cancer
  • Patients must have undergone breast surgery for the current malignancy
  • Patients may or may not have received neo/adjuvant therapy, but must be after last dose of chemotherapy and/or biologic therapy and must have sufficient resolution of side effects per physician assessment at the time of randomization
  • Patients may or may not have received breast/axilla/ post-mastectomy chest wall radiotherapy, but must be after last dose of radiotherapy and must have sufficient resolution of side effects per physician assessment at the time of randomization
  • Patients must have sufficient resolution of any surgical side effects from the last surgery per physician assessment, with no active wound healing complications at the time of randomization
  • Patients must either be initiating or have already started adjuvant hormonal treatment. Patients may already have initiated endocrine therapy at the time of randomization, but randomization must take place within 12 months of date of histological diagnosis and within 6 months of initiating standard adjuvant endocrine therapy
  • Patients may be receiving either tamoxifen or aromatase inhibitor (AI: letrozole, anastrozole, or exemestane). For premenopausal patients and men, concurrent LHRH agonist use is allowable and may also be ongoing at the time of randomization
  • Patients with prior therapy with any CDK inhibitor are ineligible
  • Patients with Stage I or IV breast cancer are not eligible
  • Pregnant women, or women of childbearing potential without a negative pregnancy test (serum or urine) within 7 days prior to randomization are excluded
  • Breastfeeding must be discontinued prior to study entry
  • Patients are not eligible if they have previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy
  • Patients on combination antiretroviral therapy, i.e. those who are HIV-positive,are ineligible
  • Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis, etc. are ineligible
  • Patients receiving concurrent exogenous hormone therapy (hormone replacement therapy, oral or any other hormonal contraceptives such as hormonal contraceptive coil, etc.) are not eligible

Applicable Disease Sites Breast

Therapies Involved Hormone Therapy; Other

Drugs Involved PD-0332991 (palbociclib); anastrozole; arimidex (anastrozole); aromasin (exemestane); exemestane; femara (letrozole); letrozole; nolvadex (tamoxifen); palbociclib; tamoxifen

Status Open

Participating Institutions Columbia St. Marys Hospital Milwaukee, Inc; St. Marys Hospital Ozaukee, Inc; UW Hospital and Clinics; UWCCC 1 South Park