Bevacizumab, Docetaxel, and Carboplatin in Treating Women With Stage II or Stage III Breast Cancer
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Purpose
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel and carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and carboplatin works in treating women with operable Stage II or stage III breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Avastin, docetaxel, carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Neoadjuvant Bevacizumab, Docetaxel and Carboplatin for Triple Negative Breast Cancer (Neat Trial) |
- pathologic complete response (pCR)after completion of 6th cycle neoadjuvant treatment [ Time Frame: After completion of 6 cycle of neoadjuvant chemotherapy followed by surgery ] [ Designated as safety issue: No ]Primary end point in our study is pCR after 6 cycle of neoadjuvant treatment followed by surgery
| Enrollment: | 45 |
| Study Start Date: | September 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
-
Drug: Avastin, docetaxel, carboplatin
OBJECTIVES:
- To determine the rate of pathological complete response in women with operable triple-negative breast cancer treated with neoadjuvant bevacizumab, docetaxel, and carboplatin.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV, docetaxel IV, and carboplatin IV on day 1. Treatment repeat every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. Patients receive docetaxel IV and carboplatin IV only during course 6. Patients undergo surgery between weeks 19-21 as planned.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
- Stage II or III disease
- No evidence of metastasis (M0)
- No inflammatory breast cancer (T4d)
- Must have a primary tumor
- Operable disease
Triple-negative disease, meeting the following criteria:
- Estrogen receptor-, progesterone receptor-, and HER2-negative by immunohistochemistry (IHC) 0 or 1+ OR fluorescence in situ hybridization negative (in case IHC is 2+)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Pre- or post-menopausal
- Not pregnant
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥10 g/dL
- Serum creatinine ≤ 1.5 mg/dL
- Total bilirubin ≤ 1.5 mg/dL
- AST/ALT ≤ 2 times normal
- Alkaline phosphatase ≤ 2 times normal
- Normal or nonspecific EKG
- LVEF ≥ 50% by MUGA or echocardiogram
- Normal mental function to understand and sign the written informed consent
- No history of uncompensated congestive heart failure
- No history of cancer except for carcinoma in situ of the uterine cervix or nonmelanoma skin cancer
- No history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- No uncontrolled hypertension (systolic BP > 150 mm Hg and/or diastolic BP > 100 mm Hg)
No history or evidence of clinically significant cardiovascular disease, including any of the following:
- Cerebrovascular accident (CVA) or stroke within the past 6 months
- Myocardial infarction (MI) within the past 6 months
- Unstable angina
- NYHA class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- No serious nonhealing wound, peptic ulcer, or bone fracture
- No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No known hypersensitivity to any of the study drugs
PRIOR CONCURRENT THERAPY:
- No prior hormone therapy, chemotherapy, or radiotherapy for breast cancer
- No prior breast surgery other than biopsy to confirm diagnosis
- No concurrent chronic daily corticosteroids (more than 10 mg/day methylprednisolone equivalent)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Joohyuk Sohn, Professor, Severance Hospital |
| ClinicalTrials.gov Identifier: | NCT01208480 History of Changes |
| Other Study ID Numbers: | CDR0000685975, KCSG-0905 |
| Study First Received: | September 23, 2010 |
| Last Updated: | April 9, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Severance Hospital:
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer triple-negative breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Docetaxel Bevacizumab Carboplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013