Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. The present trial examines the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.

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

Details

• Lead Sponsor: WiSP Wissenschaftlicher Service Pharma GmbH
• Collaborators: Bristol-Myers Squibb; Roche Pharma AG
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Trastuzumab

Criteria

Inclusion Criteria:

• histologically confirmed metastatic breast cancer overexpressing HER2

• pretreatment with anthracycline in either the adjuvant or palliative setting.

• HER2 positivity was defined as 2+ or 3+ overexpression using the DAKO HercepTest, confirmed by fluorescence in-situ hybridization (FISH) if 2+.

• informed consent

Exclusion Criteria:

• more than 1 chemotherapy for advanced disease

• taxane or trastuzumab pretreatment

• brain metastases

• Eastern Cooperative Oncology Group (ECOG) performance status >1

• pregnancy or lactation, childbearing potential without reliable contraception

• clinically significant cardiac disease,

• neutrophils <1500/µl, platelets <75,000/µl

• total bilirubin and creatinine >1.5 × the upper limit of normal