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

This study has been completed.
Information provided by (Responsible Party):
Joohyuk Sohn, Severance Hospital Identifier:
First received: September 23, 2010
Last updated: April 9, 2012
Last verified: April 2012

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: 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)

Resource links provided by NLM:

Further study details as provided by Severance Hospital:

Primary Outcome Measures:
  • pathologic complete response (pCR)after completion of 6th cycle neoadjuvant treatment [ Time Frame: After completion of 6 cycle of neoadjuvant chemotherapy followed by surgery ]
    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)
Intervention Details:
    Drug: Avastin, docetaxel, carboplatin
    Avastin, docetaxel, carboplatin
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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+)


  • 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


  • 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)
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Please refer to this study by its identifier: NCT01208480

Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Severance Hospital
Principal Investigator: Joo Hyuk Sohn, MD, PhD Severance Hospital
  More Information

Responsible Party: Joohyuk Sohn, Professor, Severance Hospital Identifier: NCT01208480     History of Changes
Other Study ID Numbers: CDR0000685975
Study First Received: September 23, 2010
Last Updated: April 9, 2012

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
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors processed this record on April 25, 2017