TC Avastin. ICORG 08-10, V6

Sponsor
Cancer Trials Ireland
Study ID
NCT00911716
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — BIOLOGICAL
  • cyclophosphamide — DRUG
  • docetaxel — DRUG
  • adjuvant therapy — PROCEDURE

Study Details

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 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) together with bevacizumab may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects of giving bevacizumab together with docetaxel and cyclophosphamide and to see how well it works in treating patients with early-stage high-risk breast cancer. This is a single arm, non randomised pilot study investigating the safety of the combination of Docetaxel + Cyclophosphamide+ Bevacizumab in the adjuvant treatment of patients with early stage, HER 2 negative, high risk breast cancer.

Key Dates

First listed
Jun 2, 2009
Start date
Oct 31, 2008
Status verified
Oct 2015
Primary completion
Jul 31, 2010
Completion
Sep 30, 2015

Study Design

Enrollment
106 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: cyclophosphamide, Docetaxel, bevacizumab

Primary Outcome Measure

Percentage of patients experiencing heart failure [ Time Frame: 5 years ]

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