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| ID | Type | Description | Link |
|---|---|---|---|
| NJ 2107 | |||
| Pro0220070274 | Other Identifier | CINJ | |
| P30CA072720 | U.S. NIH Grant/Contract | View source | |
| NCI-2012-00524 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| Rutgers Cancer Institute of New Jersey | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxil, Carboplatin and Bevacizumab | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxil | Drug | Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle. |
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| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Toppmeyer, MD | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper Hospital/University Medical Center | Camden | New Jersey | 08103 | United States | ||
| Cancer Institute of New Jersey at Hamilton |
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| Label | URL |
|---|---|
| ICH GCP Clinical Trials Registry | View source |
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We are reporting results on 31 eligible patients.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Protocol #1 | Oct 17, 2013 | Aug 19, 2022 |
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| Carboplatin | Drug | Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle. |
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| Bevacizumab | Drug | Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle. |
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| 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. | one year |
| Median Overall Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative | median overall survival | 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-month survival rate | six months |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative Metastatic Breast Cancer | Posted | Number | participants | Two Years |
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| 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 | Posted | Count of Participants | Participants | up to two years |
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| ||||||||||||||||||||||||||||
| 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. | Posted | Number | 95% Confidence Interval | participants | one year |
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| Secondary | Median Overall Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative | median overall survival | Posted | Median | 95% Confidence Interval | months | From date of randomization up to two years |
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| Secondary | Six-month Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative | Six-month survival rate | Posted | Number | 95% Confidence Interval | Percentage participants | six months |
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Adverse events were collected over 913 days per patient.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 28 | 31 | 0 | 31 | 0 | 31 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah L Toppmeyer, M.D. | Rutgers Cancer Institute of New Jersey | 732-235-6789 | toppmede@cinj.rutgers.edu |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol #2 | Oct 17, 2013 | Aug 19, 2022 | Prot_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Protocol #4SAP | Oct 17, 2013 | Aug 19, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 7, 2011 | Nov 4, 2022 | ICF_003.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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