To Compare Treatment With Doxorubicin or Capecitabine for Metastatic Breast Cancer in Women 60 Years and Older

NCT00082095 ↗

Phase 3 Terminated 62 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to compare treatment with either pegylated liposomal doxorubicin or capecitabine as first line chemotherapy for metastatic breast cancer in women 60 years and older.

Timeline

Start: 2004-04
Primary completion: 2005-12
Completion: 2005-12

Outcome

Outcome not reported

Stopped (Enrollment): “The study was terminated due to poor recruitment (after enrolling 62 of planned 300 patients in 20 months”

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

Evaluation	Drug	Modality	Dose	Route
Comparator	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	Pegylated liposomal doxorubicin	Unknown	40 mg/m2	Intravenous