Neoadjuvant TAC Plus or Minus Bevacizumab(AVF3299)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Translational Oncology Research International
Study ID
NCT00203372
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab 7.5 and TAC — DRUG
    Bevacizumab given intravenously at a dose of 7.5mg/kg every 3 weeks, followed by docetaxel, doxorubicin and cyclophosphamide (TAC).
  • Placebo 7.5 and Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) — DRUG
    placebo 7.5 will be adminitered intravenously every 3 weeks followed by TAC
  • Bevacizumab 15 and TAC — DRUG
    one dose of Bevacizumab (15 mg/kg) will be administered intravenously every 3 weeks followed by TAC.
  • Placebo 15 and TAC — DRUG
    one dose of placebo 15 will be administered intravenously every 3 weeks followed by TAC.

Study Details

The purpose of this study is to evaluate the safety of the TAC-bevacizumab combination and investigate whether changes in gene expression, or the expression of specific biomarkers, are either predictive of response to bevacizumab or indicative of response.

Key Dates

First listed
Sep 20, 2005
Start date
May 31, 2005
Status verified
Feb 2011
Primary completion
Jun 30, 2012

Study Design

Enrollment
6 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab 7.5 and TAC
    one dose of Bevacizumab (7.5mg/kg) will be administered intravenously every 3 weeks followed by TAC.
  • Placebo Comparator: Placebo 7.5 and TAC
    Placebo7.5 will be administered intravenously every 3 weeks followed by TAC.
  • Experimental: Bevacizumab 15 and TAC
    one dose of Bevacizumab (15mg/kg) will be administered intravenously every 3 weeks followed by TAC.
  • Placebo Comparator: Placebo 15 and TAC
    Placebo 15mg/kg will be administered intravenously every 3 weeks followed by TAC.

Primary Outcome Measure

•To evaluate the safety and toxicity of the TAC regimen with the addition of bevacizumab given as preoperative therapy to patients with Stage II or Stage III breast cancer [ Time Frame: 4 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
UCLA Medical CenterLos AngelesCalifornia90095-
Wilshire Oncology Medical Group, Inc.PomonaCalifornia91767-
Cancer Institute of Florida, P.A.OrlandoFlorida32804-
Northwest Georgia Oncology Centers, P.C.MariettaGeorgia30060-
South Texas Oncology and Hematology, P.A.San AntonioTexas78207-

Find similar trials in Los Angeles, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UCLA Medical Center· Los Angeles, CAWilshire Oncology Medical Group, Inc.· Pomona, CACancer Institute of Florida, P.A.· Orlando, FLNorthwest Georgia Oncology Centers, P.C.· Marietta, GASouth Texas Oncology and Hematology, P.A.· San Antonio, TX

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