Gemcitabine/Vinorelbine Versus Gemcitabine/Cisplatin Versus Gemcitabine/Capecitabine in Metastatic Breast Cancer

Summary

Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings. For each randomisation arm, 47 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective. Study Design: Arm A Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks

Timeline

Start

2002-10

Primary completion

—

Completion

—

Publications

• Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

Drugs

Indications