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A Study of Bevacizumab in Combination With Gemcitabine and Carboplatin in Participants With Triple Negative Metastatic Breast Cancer

NCT01201265 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-05-27

Study results available
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Summary

This multicenter study will assess the efficacy and safety of bevacizumab in combination with gemcitabine and cisplatin as first line treatment in participants with triple negative metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an area under curve \[AUC\]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study treatment is until disease progression.

Conditions

Interventions

DRUG

Bevacizumab

15 mg/kg iv every 3 weeks

DRUG

Carboplatin

to an AUC = 2, on days 1 and 8 of each 3-week cycle

DRUG

Gemcitabine

1000 mg/m2 iv on days 1 and 8 of each 3-week cycle

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • India

Study Locations

More Related Trials

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 NCT01201265 on ClinicalTrials.gov