Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | May 2008 |
End Date: | September 2015 |
A Phase II Trial of Doxil, Carboplatin and Bevacizumab in Triple Negative Previously Untreated Metastatic Breast Cancer
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.
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.
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
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Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
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