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| ID | Type | Description | Link |
|---|---|---|---|
| AVF36335 | Other Identifier | Genentech |
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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
| Brigham and Women's Hospital | OTHER |
| Genentech, Inc. |
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The purpose of this study is to find out what effect taking cisplatin in combination with bevacizumab before surgery and then standard chemotherapy plus bevacizumab after surgery will have on participants with Estrogen Receptor (ER) negative, Progesterone Receptor (PR) negative and Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer. Cisplatin is used to destroy cancer cells in many types of cancers, and has shown to be effective and have manageable side effects. Bevacizumab is an antibody, which is a protein that attacks a foreign substance in the body. Bevacizumab slows or stops cell growth in cancerous tumors by decreasing the blood supply to the tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cisplatin/Avastin | Experimental | Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer. | The goal of this measure was to determine the pathologic complete response rate (Miller-Payne (MP) score 5) after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Overall and Complete Response Rates After Preoperative Therapy With Cisplatin and Bevacizumab | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula D. Ryan, MD | Texas Oncology-The Woodlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Beth Israel Deaconess Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cisplatin/Avastin | cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel doxorubicin: Postoperative: Given intravenously for four 2-week cycles cyclophosphamide: Postoperative: Given intravenously for four two-week cycles paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
stage 2 or 3 triple negative breast cancer
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| ID | Title | Description |
|---|---|---|
| BG000 | Cisplatin/Avastin | Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional) cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles bevacizumab: Preoperatively: Given IV on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel doxorubicin: Postoperative: Given intravenously for four 2-week cycles cyclophosphamide: Postoperative: Given intravenously for four two-week cycles paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer. | The goal of this measure was to determine the pathologic complete response rate (Miller-Payne (MP) score 5) after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
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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 | Cisplatin/Avastin | Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional) cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel doxorubicin: Postoperative: Given intravenously for four 2-week cycles cyclophosphamide: Postoperative: Given intravenously for four two-week cycles paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Isakoff | Massachusetts General Hospital | 617 726 6500 | sisakoff@partners.org |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000068258 | Bevacizumab |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| INDUSTRY |
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| bevacizumab | Drug | Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel |
|
|
| doxorubicin | Drug | Postoperative: Given intravenously for four 2-week cycles |
|
|
| cyclophosphamide | Drug | Postoperative: Given intravenously for four two-week cycles |
|
|
| paclitaxel | Drug | Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks) |
|
|
| 2 years |
| Toxicity of Administering Bevacizumab in Combination With Standard Adjuvant Chemotherapy. | Number of patients who were unable to receive all cycles of chemotherapy on time for toxicity reasons. | 2 years |
| Patients With Miller-Payne (MP) Score 3, 4, or 5 Response | To describe a panel of molecular assays for an association with clinical response and, if feasible, with pathologic complete response (pCR) in ER-, PR-, HER2-negative subjects treated with cisplatin and bevacizumab in the preoperative setting. A Miller-Payne (MP) score of 3 indicates a decrease in the size of the cancer by 30% to 90%. A MP score of 4 indicates marked decrease in the size of the cancer by greater than 90%. A MP score of 5 indicates there is no residual cancer remaining (the same as a pathologic complete response). | 2 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Clinical Overall and Complete Response Rates After Preoperative Therapy With Cisplatin and Bevacizumab | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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 | 2 years |
|
|
|
| Secondary | Toxicity of Administering Bevacizumab in Combination With Standard Adjuvant Chemotherapy. | Number of patients who were unable to receive all cycles of chemotherapy on time for toxicity reasons. | analyzed the 43 patients who completed 4 cycles of neoadjuvant therapy and started post-operative treatment | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Patients With Miller-Payne (MP) Score 3, 4, or 5 Response | To describe a panel of molecular assays for an association with clinical response and, if feasible, with pathologic complete response (pCR) in ER-, PR-, HER2-negative subjects treated with cisplatin and bevacizumab in the preoperative setting. A Miller-Payne (MP) score of 3 indicates a decrease in the size of the cancer by 30% to 90%. A MP score of 4 indicates marked decrease in the size of the cancer by greater than 90%. A MP score of 5 indicates there is no residual cancer remaining (the same as a pathologic complete response). | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
|
|
| 0 |
| 51 |
| 51 |
| 51 |
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| 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 |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |