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Protocol No. UW16050

Principal Investigator Wisinski, Kari

Phase II

Age Group Adult

Scope National

Sponsor Type Industry; Institutional

Title A Single Arm Phase II Study of Palbociclib in Combination with Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer

Objective This study is being done to find out if adding palbociclib to tamoxifen does a better job of killing cancer. This study is being done to find out if adding palbociclib is better, the same, or worse than tamoxifen or palbociclib alone.

Treatment Tamoxifen is an active endocrine therapy for women with hormone receptor positive breast cancers. Even if the cancer first responds to tamoxifen, it can develop resistance to tamoxifen and stop working. Palbociclib is an enzyme inhibitor that interrupts the growth of cancer cells and prevents resistance to endocrine therapy. Palbociclib showed increased benefit when combined with Letrozole (an aromatase inhibitor) in postmenopausal women. Palbociclib and tamoxifen have separately been approved for use in advanced breast cancer by the FDA in the United States. However, palbociclib in combination with tamoxifen is investigational. "Investigational" means that the FDA has not approved this combination of drugs for your type of cancer.

Description Palbociclib is taken by mouth in a 4-week cycle. For the first 3 weeks, you'll take one palbociclib each day with food. For the last 7 days you will "rest" and will not take any palbociclib. At the end of 4 weeks, the cycle will start over again. Tamoxifen is taken by mouth every day without a break. Even though you'll stop taking palbociclib for the last 7 days of each cycle, tamoxifen should be taken every day throughout the study.

Key Eligibility
  • Men and women with locoregional recurrent or metastatic disease, as determined by biopsy of the metastatic lesion, not amenable to curative therapy
  • Histologically and/or cytologically confirmed diagnosis of ER positive and/or PR positive (ER >1%, PR >1%), HER2 negative metastatic breast cancer
  • Metastatic disease evaluable on imaging studies
  • No prior systemic anti-cancer therapy for advanced HR+ disease. Subjects receiving adjuvant treatment with aromatase inhibitors at time of recurrence are allowed to participate
  • Women of childbearing potential must not be pregnant or breast-feeding
  • Patients who have had prior treatment with any CDK 4/6 inhibitor are not eligible
  • Patients with confirmed diagnosis of HER2 positive disease are not eligible
  • Subjects with known brain metastasis will only be eligible after their tumors have been treated with definitive resection and /or radiotherapy and they are neurologically stable for at least 1 month off steroids
  • Subjects with advanced, symptomatic, visceral spread that have life expectancy less than 4 months are not eligible
  • Patients with prior history of blood clots, pulmonary embolism or deep vein thrombosis are not eligible
  • Patients with a known history of human immunodeficiency virus, active Hepatitis B or Hepatitis C are not eligible

Applicable Disease Sites Breast

Therapies Involved Hormone Therapy; Other

Drugs Involved PD-0332991 (palbociclib); nolvadex (tamoxifen); palbociclib; tamoxifen

Status Open

Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park