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

NCT ID: NCT01208480

Last Updated: 2012-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-02-29

Brief Summary

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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Avastin, docetaxel, carboplatin

Avastin, docetaxel, carboplatin

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joohyuk Sohn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joo Hyuk Sohn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KCSG-0905

Identifier Type: -

Identifier Source: secondary_id

CDR0000685975

Identifier Type: -

Identifier Source: org_study_id