A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer

Phase 2 Completed 225 enrolled Hoffmann-La Roche

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or metastatic breast cancer.

Timeline

Start: 2002-02
Primary completion: 2006-03
Completion: 2008-01

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Herceptin + Taxotere + Xeloda vs Herceptin + Taxotere; p = 0.717; Difference in Response Rates 2.2 (95% CI -10.17 to 14.56); Chi-squared NCT02748213 ↗

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
Subject	Capecitabine	Small molecule	950 mg/m2	Oral
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	100 mg/m2	Intravenous
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous