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Pilot Study of Docetaxel & Bevacizumab +/- Trastuzumab in First-Line Treatment of Patients With Metastatic Breast Cancer

NCT00364611 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2012-08-23

Study results available
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Summary

Pilot, phase II, parallel-group, open-label, noncomparative, prospective, multicenter study designed to evaluate the progression-free survival of docetaxel and bevacizumab ± trastuzumab for the first-line treatment of participants with metastatic breast cancer. Participants were stratified according to human epidermal growth factor receptor-2 (HER2) status at the time of enrollment. HER2 negative participants were assigned to receive docetaxel and bevacizumab (DB). HER2 positive participants were assigned to receive docetaxel, bevacizumab, and trastuzumab (DBT).

All participants (except one) were off study treatment on 30 June 2011. All efficacy analysis and safety analysis was performed using the cut-off date of June 2011. One participant continued treatment till 11 March 2012. For this participant, adverse events were collected upto 19 April 2012 and included in the safety analysis.

Conditions

Interventions

DRUG

Bevacizumab

Bevacizumab (Avastin) 15 mg/kg will be administered prior to chemotherapy on * On Day 1 of the 1st cycle over 120 minutes * On Day 1 of the 2nd cycle over 90 minutes, if no reaction on the first dose * On Day 1 of 3rd cycle over 60 minutes, if no reaction on previous doses * On Day 1 of subsequent cycles over 30 minutes, if no reaction on previous doses

DRUG

Docetaxel

Docetaxel 75 mg/m\^2 IV infused over 60 minutes after completion of Bevacizumab infusion q3w

DRUG

Trastuzumab

* A loading dose of 8 mg/kg Trastuzumab (Herceptin) IV will be infused over 90 minutes on Day 2 of Cycle 1. * For all subsequent cycles 6 mg/kg trastuzumab will be administered on Day 1 one hour following completion of docetaxel infusion

Sponsors & Collaborators

Principal Investigators

  • Barry Childs, MD · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2011-06-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00364611 on ClinicalTrials.gov