Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer

August 25, 2011 updated by: WiSP Wissenschaftlicher Service Pharma GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen
      • Glauchau, Sachsen, Germany, D-08371
        • Dr. Matthias John

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: paclitaxel/trastuzumab
Single experimental arm in a phase II trial
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: Patient follow-up on average for 15 months and up to a maximum of 51 months
Patient follow-up on average for 15 months and up to a maximum of 51 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WiSP Wissenschaftlicher Service Pharma GmbH

Collaborators

Bristol-Myers Squibb
Roche Pharma AG

Investigators

  • Principal Investigator: Matthias John, MD, Oncology Practice, Glauchau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

August 25, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (Estimate)

August 26, 2011

Study Record Updates

Last Update Posted (Estimate)

August 26, 2011

Last Update Submitted That Met QC Criteria

August 25, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WISP_RO78

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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