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

February 3, 2023 updated by: Deborah Toppmeyer, MD, Rutgers, The State University of New Jersey

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital/University Medical Center
      • Hamilton, New Jersey, United States, 08690
        • Cancer Institute of New Jersey at Hamilton
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Saint Peter's University Hospital
      • Summit, New Jersey, United States, 07901
        • Overlook Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Doxil, Carboplatin and Bevacizumab
Drug: Doxil
Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
Drug: Carboplatin
Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
Drug: Bevacizumab
Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 16, 2008

Primary Completion (ACTUAL)

July 12, 2015

Study Completion (ACTUAL)

September 25, 2015

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

February 5, 2008

First Posted (ESTIMATE)

February 6, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 040702
  • P30CA072720 (U.S. NIH Grant/Contract)
  • NJ 2107
  • Pro0220070274 (OTHER: CINJ)
  • NCI-2012-00524 (OTHER: NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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