Primary Systemic Therapy in Operable/Locally Advanced Breast Cancer

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
University of Arkansas
Study ID
NCT00203502
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Bevacizumab — DRUG
    IV 15mg/kg 21 days
  • Cyclophosphamide — DRUG
    500mg per meter squared, IV every 21 days
  • Docetaxel — DRUG
    60 mg per meter squared, IV every 21 days

Study Details

The main purpose of this study is to find out what effects taking the drug bevacizumab together with two chemotherapeutic agents, docetaxel and cyclophosphamide followed by doxorubicin alone before surgery will on breast cancer. Bevacizumab will be given for twelve weeks in combination with chemotherapy then it ill be held during the administration of doxorubicin. Twenty-eight to fifty-six days after undergoing surgery, all patients will receive nine three-weekly infusions of bevacizumab.

Key Dates

First listed
Sep 20, 2005
Start date
Sep 30, 2005
Status verified
May 2016
Primary completion
Feb 28, 2015
Completion
Feb 28, 2015

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention: Dtx Cyclophosphamide Bev
    Docetaxel 75m/m2 Cyclophosphamide 500 mg/m2 Bevacizumab 15 mg/kg

Primary Outcome Measure

Percentage of Participants With Pathological Complete Response. [ Time Frame: Participants were assessed during surgery, an average of one hour ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205-

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