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

September 23, 2010
April 9, 2012
September 2010
February 2012   (final data collection date for primary outcome measure)
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
Pathologic complete response rate [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01208480 on ClinicalTrials.gov Archive Site
Not Provided
  • Overall clinical response rate as assessed by RECIST criteria using MRI, mammography, and sonography [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Bevacizumab, Docetaxel, and Carboplatin in Treating Women With Stage II or Stage III Breast Cancer
A Phase II Trial of Neoadjuvant Bevacizumab, Docetaxel and Carboplatin for Triple Negative Breast Cancer (Neat Trial)

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:

  • 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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: Avastin, docetaxel, carboplatin
Avastin, docetaxel, carboplatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
February 2012
February 2012   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01208480
CDR0000685975, KCSG-0905
No
Joohyuk Sohn, Severance Hospital
Severance Hospital
Not Provided
Principal Investigator: Joo Hyuk Sohn, MD, PhD Severance Hospital
Severance Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP