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Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer

NCT01423695 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2011-08-26

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • WiSP Wissenschaftlicher Service Pharma GmbH

    lead OTHER

Principal Investigators

  • Matthias John, MD · Oncology Practice, Glauchau

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01423695 on ClinicalTrials.gov