Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer
A Phase II Trial of Doxil, Carboplatin and Bevacizumab in Triple Negative Previously Untreated Metastatic Breast Cancer
5 other identifiers
interventional
31
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2008
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2008
CompletedFirst Posted
Study publicly available on registry
February 6, 2008
CompletedStudy Start
First participant enrolled
May 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2015
CompletedResults Posted
Study results publicly available
February 8, 2023
CompletedFebruary 8, 2023
February 1, 2023
7.2 years
January 23, 2008
March 16, 2017
February 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative Metastatic Breast Cancer
Two Years
Secondary Outcomes (4)
Clinical Benefit Rate (CBR=CR+PR+SD)
up to two years
One-year Progression-free Survival
one year
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
Six-month Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative
six months
Study Arms (1)
Doxil, Carboplatin and Bevacizumab
EXPERIMENTALInterventions
Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
Eligibility Criteria
You may qualify if:
- Women with previously untreated metastatic breast cancer, ER/PR/HER2/neu negative.
- Age \>= 18
- ECOG performance status \<= 2
- Normal organ and marrow function
- Normal cardiac function as evidenced by LVEF within institutional normal limits
You may not qualify if:
- History of hypersensitivity reactions to doxil or bevacizumab
- Myocardial infarct or unstable angina within 6 months before enrollment
- Prior anthracycline dose exceeding 360 mg/m2 for doxorubicin (including DOXIL) or 720 mg/m2 for epirubicin.
- Proteinuria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rutgers, The State University of New Jerseylead
- Rutgers Cancer Institute of New Jerseycollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (7)
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103, United States
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, 08690, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Overlook Medical Center
Summit, New Jersey, 07901, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Deborah L Toppmeyer, M.D.
- Organization
- Rutgers Cancer Institute of New Jersey
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah Toppmeyer, MD
Rutgers Cancer Institute of New Jersey
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, CINJ
Study Record Dates
First Submitted
January 23, 2008
First Posted
February 6, 2008
Study Start
May 16, 2008
Primary Completion
July 12, 2015
Study Completion
September 25, 2015
Last Updated
February 8, 2023
Results First Posted
February 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share