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

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Doxil; Drug: Carboplatin; Drug: Bevacizumab

• Registration Number: NCT00608972
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-02-05
• Study First Posted: 2008-02-06
• Study Start: 2008-05-16
• Primary Completion: 2015-07-12
• Study Completion: 2015-09-25
• Results First Submitted: 2017-03-16
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Results First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Doxil, Carboplatin and Bevacizumab	Carboplatin	-
Doxil, Carboplatin and Bevacizumab	Doxil	-
Doxil, Carboplatin and Bevacizumab	Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative Metastatic Breast Cancer	Two Years

Secondary Outcome Measures

Name	Time	Method
One-year Progression-free Survival	one year	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.
Median Overall Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative	From date of randomization up to two years	median overall survival
Clinical Benefit Rate (CBR=CR+PR+SD)	up to two years	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
Six-month Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative	six months	Six-month survival rate

Trial Locations

Locations (7)

Saint Peter's University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

Jersey Shore University Medical Center; 🇺🇸 Neptune, New Jersey, United States

Cooper Hospital/University Medical Center; 🇺🇸 Camden, New Jersey, United States

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

Morristown Medical Center; 🇺🇸 Morristown, New Jersey, United States

Cancer Institute of New Jersey at Hamilton; 🇺🇸 Hamilton, New Jersey, United States

Overlook Medical Center; 🇺🇸 Summit, New Jersey, United States