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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective of this study is to determine the median progression free survival (PFS) and 1-year PFS after treatment with doxil, carboplatin and bevacizumab in patients with ER, PR, HER2neu negative metastatic breast cancer.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Deborah Toppmeyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMDNJ/CINJ

Authority:

United States: Institutional Review Board

Study ID:

040702

NCT ID:

NCT00608972

Start Date:

January 2008

Completion Date:

June 2014

Related Keywords:

  • Metastatic Breast Cancer
  • negative for a protein called HER2/neu
  • negative for estrogen receptors (ER) and progesterone receptors (PR).
  • breast cancer
  • Breast Neoplasms

Name

Location
Cooper Hospital/University Medical Center Camden, New Jersey  08103
Saint Peter's University Hospital New Brunswick, New Jersey  08901-1780
Cancer Institute of New Jersey (CINJ) New Brunswick, New Jersey  08901
The Cancer Institute of New Jersey at Hamilton Hamilton, New Jersey  08690