A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without a taxane for the first line treatment of metastatic breast cancer in women who have relapsed at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with Herceptin for HER2-positive early breast cancer.Patients will receive either Herceptin monotherapy (loading dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by 3-weekly doses of 6mg/kg)or Herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Albumin-Bound Paclitaxel; Docetaxel; Paclitaxel; Taxane; Trastuzumab

Criteria

Inclusion Criteria:

• at least 10 months of Herceptin treatment for HER2-positive early breast cancer;

• metastatic breast cancer >=12 months after discontinuation of Herceptin;

• measurable disease.

Exclusion Criteria:

• previous chemotherapy for metastatic breast cancer;

• brain metastases;

• invasive malignancy other than metastatic breast cancer.