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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joohyuk Sohn, Severance Hospital
ClinicalTrials.gov Identifier:
NCT01208480
First received: September 23, 2010
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208480

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

Additional Information:
No publications provided

Responsible Party: Joohyuk Sohn, Professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT01208480     History of Changes
Other Study ID Numbers: CDR0000685975, KCSG-0905
Study First Received: September 23, 2010
Last Updated: April 9, 2012
Health Authority: Korea: Food and Drug Administration

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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Bevacizumab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014