Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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paclitaxel/trastuzumab

Single experimental arm in a phase II trial

Group Type EXPERIMENTAL

paclitaxel plus trastuzumab

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No