Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

Weekly Application of Trastuzumab and Paclitaxel in the Treatment of HER2-overexpressing Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423695
• Other study ID #: WISP_RO78
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2011
• Last updated: August 25, 2011
• Start date: February 2001
• Est. completion date: December 2009

Study information

• Verified date: August 2011
• Source: WiSP Wissenschaftlicher Service Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• paclitaxel plus trastuzumab
Weekly paclitaxel (90 mg/m² iv, 12 courses) plus weekly trastuzumab (4mg/kg body weight iv as loading dose, 2 mg/kg iv from week 2 onwards; continued until disease progression)

Locations

Country	Name	City	State
Germany	Dr. Matthias John	Glauchau	Sachsen

Sponsors (3)

Lead Sponsor	Collaborator
WiSP Wissenschaftlicher Service Pharma GmbH	Bristol-Myers Squibb, Roche Pharma AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		Patient follow-up on average for 15 months and up to a maximum of 51 months	No