NCT02668666

Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Oana Danciu, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OUTLINE: This is a multi-center trial. INVESTIGATIONAL TREATMENT: * Palbociclib 125 mg will be administered orally once daily on days 1-21 (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). Palbociclib should be taken with food in combination with tamoxifen. Subjects should take their dose at approximately the same time each day. It is encouraged, but not mandatory, that premenopausal subjects will also receive treatment with goserelin or equivalent (e.g., Lupron) given as an injectable subcutaneous implant on D1 of every 28 days cycle or every 3 months. Disease assessments will be performed at the completion of every 2 cycles. Treatment will continue until disease progression, unacceptable toxicity, subject refusal, or subject death either from progression of disease, the therapy itself, or from other causes. Subjects who voluntarily stop the study, have progressive disease, or unacceptable toxicities will be followed for a total of 24 months after discontinuation of study drug. To demonstrate adequate organ function, all screening labs should be performed within 14 days prior to registration for protocol therapy: Hematological (must meet ALL of the following criteria): * Absolute neutrophil count (ANC) ≥ 1.5 × 10 9/L * Hemoglobin ≥ 9 g/dL * Platelet count ≥ 100 × 10 9/L Renal (must meet ONE of the following criteria): * Serum creatinine ≤ 1.5 × ULN * Serum creatinine \> 1.5 × ULN, estimated glomerular filtration rate (eGFR) ≥ 40 mL/min Hepatic (must meet ALL of the following criteria): * Aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases * Alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases * Total serum bilirubin ≤ 1.5 × ULN

Conditions

• Hormone Receptor Positive Malignant Neoplasm of Breast
• Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
• Estrogen Receptor Positive Breast Cancer
• Progesterone Receptor Positive Tumor
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Palbociclib	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.
DRUG	Tamoxifen	Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).

Timeline

• Start date: 2017-02-01
• Primary completion: 2023-07-03
• Completion: 2023-10-24
• First posted: 2016-01-29
• Last updated: 2026-01-20
• Results posted: 2024-07-29

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study