Preoperative Chemotherapy in Triple Negative Invasive Breast Cancer That Can be Removed by Surgery.

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
University of Tennessee Cancer Institute
Study ID
NCT00777673
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab, nab-paclitaxel, carboplatin, doxorubicin hydrochloride, cyclophosphamide, PEG-Filgrastim — DRUG
    Eligible patients will receive: * nab-paclitaxel IV on days 1, 8, and 15. Treatment will be repeated every 28 days 28 days for 4 courses. * Carboplatin IV on day 1. Treatment will be repeated every 28 days for 4 courses. * Bevacizumab IV on days 1 and 15. Treatment will be repeated every 28 days for 4 courses. After completion of the above regimen, patients will receive: * Doxorubicin IV on day 1. Treatment will be repeated every 14 days for 4 courses. * Cyclophosphamide IV on day 1. Treatment will be repeated every 14 days for 4 courses. * Bevacizumab IV on day 1. Treatment will be repeated every 14 days for 2 courses. Patients will then proceed with: \- Surgery including axillary staging A minimum of 4 weeks post operatively, patient will receive: \- Bevacizumab IV on days 1 and 15. Treatment will be repeated every 28 days for 8 courses.

Study Details

The purpose of this study is to determine how well this combination of chemotherapy drugs works with bevacizumab in eliminating primary tumor in the breast prior to surgery(pathological complete response or pCR in the breast). Bevacizumab is a drug that works by blocking new blood vessel formation by the tumor cells. Giving chemotherapy and bevacizumab before surgery may allow for lesser amount of breast tissue to be removed. To be able to predict in the future which patients are more likely to get pCR to this drug combination, specialized tests on tumor tissue will be performed.

Key Dates

First listed
Oct 22, 2008
Start date
Oct 31, 2008
Status verified
Jan 2013
Primary completion
Jan 31, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Pathological complete response (pCR) in the breast [ Time Frame: No interim efficacy analysis is planned. It is anticipated that the definitive analysis would be performed approximately 3 years after initiation of accrual (2 years to accrue 60 patients plus one additional year of follow up) ]

Locations (3)

FacilityCityStateZIPSite coordinators
The West ClinicMemphisTennessee38120-
University of Tennessee Cancer InstituteMemphisTennessee38104-
The Center for Cancer and Blood DisordersFort WorthTexas76104-

Find similar trials in Memphis, TN

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
The West Clinic· Memphis, TNUniversity of Tennessee Cancer Institute· Memphis, TNThe Center for Cancer and Blood Disorders· Fort Worth, TX

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