Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Nonmetastatic Breast Cancer

Sponsor
Cambridge University Hospitals NHS Foundation Trust
Study ID
NCT01093235
Phase
PHASE3
Status
Unknown

Conditions

  • Breast Cancer
  • Cardiac Toxicity
  • Perioperative/Postoperative Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
  • cyclophosphamide — DRUG
  • docetaxel — DRUG
  • epirubicin hydrochloride — DRUG
  • fluorouracil — DRUG
  • assessment of therapy complications — PROCEDURE
  • neoadjuvant therapy — PROCEDURE
  • quality-of-life assessment — PROCEDURE
  • therapeutic conventional surgery — PROCEDURE

Study Details

RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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. It is not yet known whether giving combination chemotherapy together with or without bevacizumab is more effective in treating patients with nonmetastatic breast cancer. PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy works compared with giving combination chemotherapy together with bevacizumab in treating patients with nonmetastatic breast cancer.

Key Dates

First listed
Mar 25, 2010
Start date
Apr 30, 2009
Status verified
Mar 2010
Primary completion
Apr 30, 2012

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

Primary Outcome Measure

Complete pathological response rates (tumor and lymph nodes)

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