Preoperative Cisplatin and Bevacizumab in ER-, PR-, Her-2 Negative Breast Cancer
Overview[ - collapse ][ - ]
| Purpose | 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 ER negative, PR negative and HER-2 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. |
|---|---|
| Condition | Breast Cancer |
| Intervention | Drug: cisplatin Drug: bevacizumab Drug: doxorubicin Drug: cyclophosphamide Drug: paclitaxel |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Responsible Party | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier | NCT00580333 |
| First Received | December 20, 2007 |
| Last Updated | April 29, 2013 |
| Last verified | April 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 20, 2007 |
|---|---|
| Last Updated Date | April 29, 2013 |
| Start Date | September 2007 |
| Estimated Primary Completion Date | December 2013 |
| Current Primary Outcome Measures | To determine the pathologic complete response rate after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer. [Time Frame: 2 years] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Preoperative Cisplatin and Bevacizumab in ER-, PR-, Her-2 Negative Breast Cancer |
|---|---|
| Official Title | A Phase II Trial of Preoperative Cisplatin and Bevacizumab in ER-, PR-, Her-2 Negative Breast Cancer |
| Brief Summary | 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 ER negative, PR negative and HER-2 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. |
| Detailed Description | - To prepare for surgery, a small "clip" will be placed into the tumor area so that the surgeon can locate the site of the tumor at the time of surgery. This is a standard procedure for breast cancer. - The study drugs will be given in four 3-week cycles (about 3 months). Participants will come into the clinic each day they receive study treatment intravenously. Cisplatin will be given on day one of the treatment cycle (once every 3 weeks) for four cycles. Bevacizumab will be given on day one of the treatment cycle for three cycles. - On day one of each 3-week cycle a physical exam, routine blood tests and urine test will be performed. 7-8 days after chemotherapy, blood tests and a hearing test will be performed. A preoperative study visit will take place 7-10 days before surgery and a physical exam, routine blood tests, EKG and an MRI of the breast will be performed. - Surgery to remove the tumor will occur at least three weeks after the last dose of cisplatin and is considered standard of care. - Postoperative chemotherapy will begin at least three weeks after surgery. Everyone on the research study will receive four 2-week cycles of doxorubicin and cyclophosphamide plus bevacizumab. After the 8 weeks, the doctor will decide which of the following two treatment regimens the participant will receive: Bevacizumab for four 2-week cycles (once every two weeks) or; Paclitaxel plus bevacizumab for four 2-week cycles (once every two weeks). - At the end of the postoperative chemotherapy, the participant will return to the clinic for a medical history, physical exam, vital signs, performance status, routine blood tests, MUGA or Echo Scans, and a hearing test. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Breast Cancer |
| Intervention | Drug: cisplatin Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles Drug: 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 Drug: doxorubicin Postoperative: Given intravenously for four 2-week cycles Drug: cyclophosphamide Postoperative: Given intravenously for four two-week cycles Drug: 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) |
| Study Arm (s) | Experimental: Cisplatin/Avastin |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 40 |
| Estimated Completion Date | December 2013 |
| Estimated Primary Completion Date | December 2010 |
| Eligibility Criteria | Inclusion Criteria: - All tumors must be ER-, PR- and HER2-negative - Clinical stage T2 or T3, NO-3, MO. Subjects with inflammatory breast cancer are not eligible - For subjects with clinically negative axilla, a sentinel lymph node biopsy will be performed either up front or after preoperative therapy at the discretion of the subject's physicians; for subjects with a clinically positive axilla, a needle aspiration or core biopsy will be performed to confirm the presence of metastatic disease in the lymph nodes. - 18 years of age or older - Performance status of 0 or 1 - Use of an effective means of contraception in subjects of child-bearing potential - Normal organ function as described in the protocol Exclusion Criteria: - Any prior cytotoxic chemotherapy or radiation for the current breast cancer - HER2-negative ipsilateral breast recurrence, unless prior treatment consisted of excision alone for DCIS or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer - Life expectancy of less than 12 weeks - Current, recent, or planned participation in an experimental durg study other than a Genentech-sponsored bevacizumab cancer study - Renal dysfunction for which exposure to cisplatin would require dose modifications - Steroid dependent asthma - Peripheral neuropathy of any etiology that exceeds grade 1 - Uncontrolled diabetes - History of malignancy treated without curative intent - Any other pre-existing medical condition that would represent toxicity in excess of grade 1 - Inadequately controlled hypertension - Any prior history of hypertensive crisis or hypertensive encephalopathy - NYHA Grade II or greater congestive hear failure - History of myocardial infarction or unstable angina within 12 months prior to study enrollment - Any history of stroke or transient ischemic attack at any time - Known CNS disease - Significant vascular disease - Symptomatic peripheral vascular disease - Evidence of bleeding diathesis or coagulopathy - Major surgical procedure, open biopsy, or significant traumatic injury within 21 days prior to study enrollment - History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to study enrollment - Serious, non-healing wound, ulcer or bone fracture - Proteinuria at screening - Known hypersensitivity to any component of bevacizumab - Pregnant or lactating |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00580333 |
|---|---|
| Other Study ID Numbers | 06-202 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Massachusetts General Hospital |
| Study Sponsor | Massachusetts General Hospital |
| Collaborators | Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Brigham and Women's Hospital Genentech |
| Investigators | Principal Investigator: Paula D. Ryan, MD Fox Chase Cancer Center |
| Verification Date | April 2013 |
Locations[ + expand ][ + ]
| Massachusetts General Hospital | Boston, Massachusetts, United States, 02114 |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts, United States, 02115 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts, United States, 02115 |