NCT01124695

Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer

A Phase II Prospective Trial Correlating Progression Free Survival With CYP2D6 Activity in Patients With Metastatic Breast Cancer Treated With Single Agent Tamoxifen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight cancer by blocking the use of estrogen by tumor cells. PURPOSE: This phase II trial is studying how well tamoxifen citrate works in patients with metastatic or recurrent breast cancer.

Detailed description

OBJECTIVES: Primary * To correlate CYP2D6 (Cytochrome P450 2D6) score (0 vs 1-2) and progression-free survival (PFS) Secondary * To correlate CYP2D6 score (0 vs 1 vs 2) and PFS * To correlate CYP2D6 score (0 vs 1-2) and the proportion of these patients who are progression-free at 6 months. * To correlate endoxifen concentration with response * To correlate CYP2D6 with response * To correlate the presence of candidate estrogen receptor (ESR) 1 and 2 variant alleles, UDP-glucuronosyltransferases (UGT) 7, sulfotransferases (SULT) 1A1, other candidate genes and biomarkers to PFS and other tamoxifen related outcomes OUTLINE: This is a multicenter study. Patients receive oral tamoxifen citrate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Blood, plasma, and tissue samples are collected periodically for laboratory studies. After completion of study therapy, patients are followed up every 3-6 months for 5 years.

Conditions

• Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	tamoxifen	PO

Timeline

• Start date: 2011-01-07
• Primary completion: 2020-11-30
• Completion: 2022-12-01
• First posted: 2010-05-17
• Last updated: 2023-06-29
• Results posted: 2023-03-14

Locations

294 sites across 3 countries: United States, Canada, Peru

Regulatory

• FDA-regulated drug study