Clinical trial NCT00608972: Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer
Official title: A Phase II Trial of Doxil, Carboplatin and Bevacizumab in Triple Negative Previously Untreated Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: negative for a protein called HER2/neu
negative for estrogen receptors (ER) and progesterone receptors (PR).
breast cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Rutgers Cancer Institute of New Jersey
name: National Cancer Institute (NCI)
First posted: 2008-02-06
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival (PFS) After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative Metastatic Breast Cancer
timeFrame: Two Years
Secondary outcomes:
measure: Clinical Benefit Rate (CBR=CR+PR+SD)
timeFrame: up to two years
measure: One-year Progression-free Survival
timeFrame: one year
measure: Median Overall Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative
timeFrame: From date of randomization up to two years
measure: Six-month Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative
timeFrame: six months
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper Hospital/University Medical Center
state: New Jersey
city: Hamilton
country: United States
facility: Cancer Institute of New Jersey at Hamilton
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Deborah Toppmeyer, MD
role: PRINCIPAL_INVESTIGATOR
References: