At a glance
ClinicalIndex Comparison Record- ✓Metastatic, locoregionally recurrent, or locally advanced HR+ (ER >1% or PR >1%), HER2-negative breast cancer not amenable to curative therapy
- ✓Metastatic disease evaluable on imaging; measurable disease per RECIST 1.1, bone-only disease, or previously irradiated lesions with documented progression allowed
- ✓No prior systemic anti-cancer therapy for advanced HR+ disease; prior adjuvant aromatase inhibitors allowed with no washout required
- ✓Age ≥18 years at time of consent; both pre- and post-menopausal women eligible
- ✕Prior treatment with any CDK 4/6 inhibitor
- ✕Confirmed HER2-positive disease
- ✕Uncontrolled or symptomatic CNS metastases; treated brain metastases only eligible if neurologically stable for ≥1 month off steroids
- ✕Prior (neo)adjuvant tamoxifen within 12 months before study entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Arm Phase II Study of Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer: Big Ten Cancer Research Consortium BTCRC-BRE15-016
In Brief
A Phase 2 clinical trial evaluating Palbociclib and Tamoxifen for Hormone Receptor Positive Malignant Neoplasm of Breast and 4 related conditions. Completed, enrolled 49 participants across 7 sites.
Detailed Summary
This is a non-randomized, open-label, single-arm, multicenter, phase II study of palbociclib in combination with tamoxifen in women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anticancer therapies for their advanced/metastatic disease.
Study Details
Timeline
Interventions
Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28.
Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).