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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01208480
Recruitment Status : Completed
First Posted : September 24, 2010
Last Update Posted : April 10, 2012
Information provided by (Responsible Party):
Joohyuk Sohn, Severance Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Avastin, docetaxel, carboplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Neoadjuvant Bevacizumab, Docetaxel and Carboplatin for Triple Negative Breast Cancer (Neat Trial)
Study Start Date : September 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • Drug: Avastin, docetaxel, carboplatin
    Avastin, docetaxel, carboplatin

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01208480

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

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Responsible Party: Joohyuk Sohn, Professor, Severance Hospital Identifier: NCT01208480     History of Changes
Other Study ID Numbers: CDR0000685975
First Posted: September 24, 2010    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012
Keywords provided by Joohyuk Sohn, 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:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action