Preoperative Cisplatin and Bevacizumab in ER-, PR-, HER2 Negative Breast Cancer
|ClinicalTrials.gov Identifier: NCT00580333|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2007
Results First Posted : March 31, 2017
Last Update Posted : August 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: cisplatin Drug: bevacizumab Drug: doxorubicin Drug: cyclophosphamide Drug: paclitaxel||Phase 2|
- 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, Electrocardiogram (EKG) and an Magnetic Resonance Imaging (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, multiple gated acquisition scan (MUGA) or Echocardiogram Scans, and a hearing test.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Preoperative Cisplatin and Bevacizumab in Estrogen Receptor (ER) Negative, Progesterone (PR) Negative, Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||June 2020|
Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)
Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles
Other Name: platinolDrug: 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
Other Name: AvastinDrug: doxorubicin
Postoperative: Given intravenously for four 2-week cycles
Other Name: adriamycinDrug: cyclophosphamide
Postoperative: Given intravenously for four two-week cycles
Other Name: cytoxanDrug: 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)
Other Name: taxol
- 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. [ Time Frame: 2 years ]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.
- Clinical Overall and Complete Response Rates After Preoperative Therapy With Cisplatin and Bevacizumab [ Time Frame: 2 years ]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.
- Toxicity of Administering Bevacizumab in Combination With Standard Adjuvant Chemotherapy. [ Time Frame: 2 years ]Number of patients who were unable to receive all cycles of chemotherapy on time for toxicity reasons.
- Patients With Miller-Payne (MP) Score 3, 4, or 5 Response [ Time Frame: 2 years ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580333
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Paula D. Ryan, MD||Texas Oncology-The Woodlands|