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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608972
• Other study ID #: 040702
• Secondary ID: NJ 2107Pro022007
• Status: Completed
• Phase: Phase 2
• Start date: May 16, 2008
• Est. completion date: September 25, 2015

Study information

• Verified date: February 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 25, 2015
• Est. primary completion date: July 12, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Doxil
Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
• Carboplatin
Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
• Bevacizumab
Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.

Locations

Country	Name	City	State
United States	Cooper Hospital/University Medical Center	Camden	New Jersey
United States	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey
United States	Morristown Medical Center	Morristown	New Jersey
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	Overlook Medical Center	Summit	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative Metastatic Breast Cancer		Two Years
Secondary	Clinical Benefit Rate (CBR=CR+PR+SD)	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR	up to two years
Secondary	One-year Progression-free Survival	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	one year
Secondary	Median Overall Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative	median overall survival	From date of randomization up to two years
Secondary	Six-month Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative	Six-month survival rate	six months

External Links

•   Abstract P3-10-09: A Phase II trial of doxil, carboplatin and bevacizumab in metastatic triple negative breast cancer and molecular correlates of response
•   ICH GCP Clinical Trials Registry