Breast Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

31

Study ID:

NCT00608972

Recruitment Status:

Completed

Sponsor:

Rutgers, The State University of New Jersey

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There are 7 Locations for this study

See Locations Near You

Cooper Hospital/University Medical Center
Camden New Jersey, 08103, United States
Cancer Institute of New Jersey at Hamilton
Hamilton New Jersey, 08690, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
Jersey Shore University Medical Center
Neptune New Jersey, 07753, United States
Saint Peter's University Hospital
New Brunswick New Jersey, 08901, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
Overlook Medical Center
Summit New Jersey, 07901, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

31

Study ID:

NCT00608972

Recruitment Status:

Completed

Sponsor:


Rutgers, The State University of New Jersey

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