Phase 2
N=31
Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer
Metastatic Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00608972 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Progression Free Survival (PFS) After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative Metastatic Breast Cancer — 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Doxil (Drug); Carboplatin (Drug); Bevacizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative Metastatic Breast Cancer |
6 | — |
| SECONDARY Clinical Benefit Rate (CBR=CR+PR+SD) |
13 | — |
| SECONDARY One-year Progression-free Survival |
31 | — |
| SECONDARY Median Overall Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative |
11 | — |
| SECONDARY Six-month Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative |
41.9 | — |
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
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00608972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.