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A Phase II Trial of Neoadjuvant Bevacizumab, Docetaxel and Carboplatin for Triple Negative Breast Cancer (Neat Trial)

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Phase II Trial of Neoadjuvant Bevacizumab, Docetaxel and Carboplatin for Triple Negative Breast Cancer (Neat Trial)


- To determine the rate of pathological complete response in women with operable
triple-negative breast cancer treated with neoadjuvant bevacizumab, docetaxel, and

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.

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pathologic complete response (pCR)after completion of 6th cycle neoadjuvant treatment

Outcome Description:

Primary end point in our study is pCR after 6 cycle of neoadjuvant treatment followed by surgery

Outcome Time Frame:

After completion of 6 cycle of neoadjuvant chemotherapy followed by surgery

Safety Issue:


Principal Investigator

Joo Hyuk Sohn, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Severance Hospital


Korea: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

February 2012

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • triple-negative breast cancer
  • Breast Neoplasms