View Clinical Trial (Medical Research Study)
A Phase II Trial of Doxil, Carboplatin and Bevacizumab in Triple Negative Previously Untreated Metastatic Breast Cancer
| City: |
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Hamilton |
| State: |
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New Jersey |
| Zip Code: |
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08690 |
| Conditions: |
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Metastatic Breast Cancer |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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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| NCT ID: |
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NCT00608972 |
| Primary Contact: |
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Principal Investigator
Deborah Toppmeyer, MD
UMDNJ/CINJ
Deborah Toppmeyer, MD
Phone: 732-235-9692
Email: toppmede@umdnj.edu
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| Backup Contact: |
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Email: tanglb@umdnj.edu
Lien Huzzy, RN, BSN, OCN
Phone: 732-235-8962
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| Location Contact: |
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Hamilton, New Jersey 08690
United States
Michael Eleff, MD
Phone: 609-631-6946
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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