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

NCT01208480 | Completed Phase 2

• 2 other identifiers: CDR0000685975KCSG-0905
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; triple-negative breast cancer

Outcome Measures

Primary Outcomes (1)

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

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

  After completion of 6 cycle of neoadjuvant chemotherapy followed by surgery

Interventions

Avastin, docetaxel, carboplatin DRUG

Avastin, docetaxel, carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Severance Hospital: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Bevacizumab; Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Joo Hyuk Sohn, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 24, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 10, 2012

Record last verified: 2012-04

Locations

KR (1)