TC Avastin. ICORG 08-10, V6

Status Completed

Clinical Trial 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 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.

Clinical Trial Description

OBJECTIVES:

Primary

- Assess the feasibility of the combination of adjuvant bevacizumab, docetaxel, and cyclophosphamide in patients with early-stage HER2-negative high-risk breast cancer.

- Determine the safety of this regimen with regards to cardiac toxicity, hypertension, and bleeding complications in these patients.

Secondary

- Evaluate the efficacy of this regimen by measuring Topo II overexpression in these patients.

OUTLINE: This is a multicenter study.

Patients will receive 4 cycles of Docetaxel 75mg/m2 + 4 cycles of Cyclophosphamide 600mg/m2 (each cycle lasts 21 days) (+/- 3 days if a due date could not be met because of public holidays, etc) and concomitant Avastin (Bevacizumab) 15mg/kg q 3weeks for treatment duration of one year.

Bevacizumab at a dose of 15mg/kg will be administered as an intravenous infusion every 3 weeks for a treatment period of one year, regardless of missed doses.

Patients will be followed up through 5 years (i.e. from the time of registration through to end of Year 5/ 1 year treatment and 4 years follow up). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00911716
Study type	Interventional
Source	Cancer Trials Ireland
Contact
Status	Completed
Phase	N/A
Start date	October 2008
Completion date	September 2015

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.