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| ID | Type | Description | Link |
|---|---|---|---|
| KCSG-0905 |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avastin, docetaxel, carboplatin | Drug | Avastin, docetaxel, carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| pathologic complete response (pCR)after completion of 6th cycle neoadjuvant treatment | Primary end point in our study is pCR after 6 cycle of neoadjuvant treatment followed by surgery | After completion of 6 cycle of neoadjuvant chemotherapy followed by surgery |
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DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
Must have a primary tumor
Operable disease
Triple-negative disease, meeting the following criteria:
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Joo Hyuk Sohn, MD, PhD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |