Metastatic Breast Cancer
Conditions
Keywords
negative for a protein called HER2/neu, negative for estrogen receptors (ER) and progesterone receptors (PR)., breast cancer
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.
Interventions
DRUGDoxil
Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
DRUGCarboplatin
Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
DRUGBevacizumab
Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
Sponsors
Rutgers Cancer Institute of New Jersey
National Cancer Institute (NCI)
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative Metastatic Breast Cancer | Two Years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Six-month Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative | six months | Six-month survival rate |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited through the Rutgers Cancer Institute of New Jersey Oncology Group. They study was open to accrual on 05/16/2008 and closed to accrual on 12/31/2012.
Pre-assignment details
We are reporting results on 31 eligible patients.
Participants by arm
| Arm | Count |
|---|---|
| Doxil, Carboplatin and Bevacizumab 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. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Doxil, Carboplatin and Bevacizumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 28 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxil, Carboplatin and Bevacizumab | Progression Free Survival (PFS) After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative Metastatic Breast Cancer | 6 participants |
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
Time frame: up to two years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Doxil, Carboplatin and Bevacizumab | Clinical Benefit Rate (CBR=CR+PR+SD) | 13 Participants |
Secondary
Median Overall Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative
median overall survival
Time frame: From date of randomization up to two years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Doxil, Carboplatin and Bevacizumab | Median Overall Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative | 11 months |
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.
Time frame: one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxil, Carboplatin and Bevacizumab | One-year Progression-free Survival | 31 participants |
Secondary
Six-month Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative
Six-month survival rate
Time frame: six months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxil, Carboplatin and Bevacizumab | Six-month Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative | 41.9 Percentage participants |