Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat 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

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-08-31

Brief Summary

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This is a phase II, multicenter, single-arm, open-label safety and efficacy study of bavituximab in combination with carboplatin plus paclitaxel in patients with locally advanced or metastatic breast cancer.

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Detailed Description

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Conditions

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Carcinoma Breast Stage IV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bavituximab

Receive weekly bavituximab at a dose of 3 mg/kg until disease progression, and carboplatin at a dose of AUC = 2 and paclitaxel 100 mg/m2 on days 1, 8, and 15 of a 28-day cycle for up to 6 cycles.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Living in India for the duration of the study
* Adult females over age 18 years of age with a life expectancy of at least 3 months
* Confirmed breast cancer with evidence of locally advanced or metastatic disease
* Disease that is measurable by radiology imaging
* Ambulatory and capable of all selfcare but unable to carry out any work activities.
* Adequate laboratory results (hematologic, renal, hepatic)
* Negative pregnancy test

Exclusion Criteria

* History of or susceptibility to bleeding or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
* Any history of thromboembolic events (clots within blood vessels)
* Ongoing treatment with high doses of anticoagulants
* Use of hormone therapy
* Advanced peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities)
* Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
* Radiotherapy within 2 weeks entering the study
* Chemotherapy, immunotherapy or radiotherapy within 4 weeks of starting the study
* Allergies to Polysorbate 80 or drugs containing polyoxyethylated castor oil (e.g. cyclosporine)
* Diagnosed and active CNS disease or metastatic lesions
* Major surgery within 4 weeks of starting the study
* Pregnant or nursing
* Uncontrolled disease (e.g., diabetes, hypertension, thyroid disease)
* History of heart disease
* History of any condition requiring treatment with anti-inflammatory, anti-platelet drugs or steroids
* Diagnosed with HIV or hepatitis

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No