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Clinical Trial Details

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Brief Title A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer
Official Title Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Hormone Receptor Positive Metastatic Breast Cancer Previously Exposed to Inhibitors of the PI3K Pathway: A Phase II Study With Pharmacodynamics Markers
Principal Investigator Nanda, Rita
Brief Summary Approximately 70 patients with HR+ advanced breast cancer will be enrolled. All patients will receive either fulvestrant (500 mg IM every 2 weeks x 3 then every four weeks) or tamoxifen (20 mg PO 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 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.
Gender Both
Ages 18 Years
Enrollment 70
Accepts Healthy Volunteers No
Lead Sponsor University of California, San FranciscoOther
Collaborator
Study Design Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 2
Study Type Interventional
Contact Name Hope Rugo, M.D.
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Metastatic Breast Cancer
Detail for Health Professional (on clinicaltrials.gov)
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