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
-
-
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
|
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.
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.