Bevacizumab, Docetaxel, and Carboplatin in Treating Women With Stage II or Stage III Breast Cancer

Yonsei University

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Avastin, docetaxel, carboplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01208480

KCSG-0905

CDR0000685975

Details and patient eligibility

About

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.

Full description

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.

Enrollment

45 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)