Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer

Rutgers The State University of New Jersey

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Doxil; Drug: Carboplatin; Drug: Bevacizumab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00608972

NCI-2012-00524 (Other Identifier)

NJ 2107

P30CA072720 (U.S. NIH Grant/Contract)

040702

Pro0220070274 (Other Identifier)

Details and patient eligibility

About

The purpose of this research study is to look at the effectiveness of a combination of doxil, carboplatin and bevacizumab on metastatic breast cancer. The type of breast cancer being studied is negative for a protein called HER2/neu and for estrogen receptors (ER) and progesterone receptors (PR). HER2/neu, ER and PR are part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types.This study is being conducted for the following research purposes:· To find out what effects, if any, the study drug has on metastatic breast cancer. For instance, will the study drug cause the tumor(s) to shrink or stop growing?· To test the safety of the study drugs and to see what affects it has. For instance, are there any side effects? If so, what kind of side effects does the study drug cause? How severe are the side effects, and how often do they occur?· To see if the study drugs have any effect on keeping the disease from getting worse.

Enrollment: 31 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women with previously untreated metastatic breast cancer, ER/PR/HER2/neu negative.
2. Age >= 18
3. ECOG performance status <= 2
4. Normal organ and marrow function
5. Normal cardiac function as evidenced by LVEF within institutional normal limits

Exclusion criteria

1. History of hypersensitivity reactions to doxil or bevacizumab
2. Myocardial infarct or unstable angina within 6 months before enrollment
3. Prior anthracycline dose exceeding 360 mg/m2 for doxorubicin (including DOXIL) or 720 mg/m2 for epirubicin.
4. Proteinuria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Doxil, Carboplatin and Bevacizumab

Experimental group

Treatment:

Drug: Bevacizumab

Drug: Doxil

Drug: Carboplatin