A Phase II Trial of Neoadjuvant Bevacizumab, Docetaxel and Carboplatin for Triple Negative Breast Cancer (Neat Trial)
18 Years
N/A
Female
Breast Cancer
Trial Information
A Phase II Trial of Neoadjuvant Bevacizumab, Docetaxel and Carboplatin for Triple Negative Breast Cancer (Neat Trial)
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.
Inclusion Criteria
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)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
pathologic complete response (pCR)after completion of 6th cycle neoadjuvant treatment
Outcome Description:
Primary end point in our study is pCR after 6 cycle of neoadjuvant treatment followed by surgery
Outcome Time Frame:
After completion of 6 cycle of neoadjuvant chemotherapy followed by surgery
Safety Issue:
No
Principal Investigator
Joo Hyuk Sohn, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Severance Hospital
Authority:
Korea: Food and Drug Administration
Study ID:
CDR0000685975
NCT ID:
NCT01208480
Start Date:
September 2010
Completion Date:
February 2012
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- triple-negative breast cancer
- Breast Neoplasms
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