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TBCRC035

Palbociclib in Combination with Fulvestrant or Tamoxifen as Treatment for Hormone Receptor Positive Metastatic Breast Cancer with Prior Chemotherapy for Advanced Disease: A Phase II study with Pharmacodynamics Markers (TBCRC035)

Status: Open to Accrual

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 collaborating statistician at Dana-Farber Cancer Institute.

  • Condition: Metastatic Breast Cancer, Hormone Receptor Positive
  • Intervention:
    • Drug: Palbociclib
  • Phase: Phase 2

For full description, see www.clinicaltrials.gov.

Project Manager: Donna LaPlaca Sullivan, dsullivan@hoosiercancer.org; (317) 634-5842, ext. 40.