A Phase 2 interventional study of carboplatin and bevacizumab in Metastatic Breast Cancer, sponsored by University of Chicago. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-15.
Sponsored by University of Chicago · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the progression free survival (PFS) of metastatic ER, PR and HER2/neu negative breast cancers to the combination of carboplatin and bevacizumab (Avastin®) therapy.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 11 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Chicago is the lead sponsor of 924 studies on the registry; 186 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 71 (70%) have results posted.
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Exclusion Criteria:
Drug: carboplatin · Drug: bevacizumab
AUC 6 in 250mL saline IV over 30 minutes
15mg/kg in 100mL saline IV over 60 - 90 minutes
Also known as: Avastin
Progression Free Survival
Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Up to 5 years
Response Rate
Response is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]: Complete Response (CR), Disappearance of all target lesions or disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.
Time frame: Up to 5 years
Duration of Response
Time frame: Up to 5 years
Correlation of Response to BRCA1 Methylation Status
The methylation status of the tumor is defined using Methylation Specific polymerase chain reaction and/or pyrosequencing.
Time frame: Up to 5 years
| Milestone | Carboplatin + Avastin |
|---|---|
| Started | 11 |
| Completed | 0 |
| Not completed | 11 |
| Withdrew: Death | 6 |
| Withdrew: The study was terminated | 5 |
Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
No measurements were reported for this outcome.
Response is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]: Complete Response (CR), Disappearance of all target lesions or disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
The methylation status of the tumor is defined using Methylation Specific polymerase chain reaction and/or pyrosequencing.
No measurements were reported for this outcome.
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Carboplatin + Avastin | — | 1/11 (9.1%) | 9/11 (81.8%) |
| Event | Carboplatin + Avastin |
|---|---|
| nauseaGeneral disorders | 1/11 |
| VomitingGastrointestinal disorders | 1/11 |
| painGeneral disorders | 1/11 |
| severe weaknessNervous system disorders | 1/11 |
| Event | Carboplatin + Avastin |
|---|---|
| PlateletsInvestigations | 6/11 |
| FatigueGeneral disorders | 5/11 |
| nauseaGastrointestinal disorders | 4/11 |
| Alanine aminotransferase increasedInvestigations | 3/11 |
| Aspartate aminotransferase increasedInvestigations | 3/11 |
| LeukocytesInvestigations | 3/11 |
| NeutrophilsInvestigations | 3/11 |
| Hemorrhage nasalRespiratory, thoracic and mediastinal disorders | 3/11 |
| HypertensionVascular disorders | 3/11 |
| VomitingGastrointestinal disorders | 2/11 |
| Age, Continuous(years) | Carboplatin + Avastin |
|---|---|
| Mean | 47.7 ± 12 |
| Sex: Female, Male(Participants) | Carboplatin + Avastin |
|---|---|
| Female | 11 |
| Male | 0 |
This study is terminated, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Carboplatin · Bevacizumab