A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer
Status:
Completed
Trial end date:
2021-01-31
Target enrollment:
Participant gender:
Summary
Approximately 70 patients with hormone receptor positive (HR+) advanced breast cancer will be
enrolled. All patients will receive either fulvestrant (500 mg intramuscular (IM) every 2
weeks x 3 then every four weeks) or tamoxifen (20 mg orally daily by physician choice).
Pre-menopausal women must be in chemical menopause.
Arm 1 will receive palbociclib 100 mg qd, days 1-21 every 28 days. Arm 2 will receive
palbociclib 125 mg qd, days 1-21 every 28 days. Restaging will be performed every 8 weeks.
Therapy will be continued until progressive disease (PD) or unacceptable toxicity.
Patients will be randomly allocated in a 1:1 ratio to take either 100 mg or 125 mg of
palbociclib. Randomized treatment assignments will be made by permuted blocks, generated by
our collaborating statistician at Dana-Farber Cancer Institute.