Therapy With Bevacizumab (BEV), Doxorubicin, and Cyclophosphamide Followed by BEV, Docetaxel, and Capecitabine Before Surgery Followed by BEV Alone After Surgery for Women With Locally Advanced Breast Cancer

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
NSABP Foundation Inc
Study ID
NCT00365417
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    15 mg/kg IV every 21 days x 4 cycles, then after clinical response assessment, 15 mg/kg IV every 21 days x 2 cycles, then following surgery, 15 mg/kg every 21 days x 10 cycles
  • Doxorubicin — DRUG
    60 mg/m\^2 IV every 21 days x 4 cycles
  • Cyclophosphamide — DRUG
    600 mg/m\^2 IV every 21 days x 4 cycles
  • Capecitabine — DRUG
    Following clinical response assessment, 650 mg/m\^2 twice a day (orally), days 1-14 every 21 days x 4 cycles
  • Docetaxel — DRUG
    Following clinical response assessment, 75 mg/m\^2 IV every 21 days x 4 cycles

Study Details

Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy drugs kill cancer cells more directly. This study will evaluate: * How bevacizumab, given with chemotherapy before surgery, and then bevacizumab given alone after surgery, will affect locally advanced breast tumors * Side effects from adding bevacizumab to chemotherapy * Whether adding bevacizumab to chemotherapy for breast cancer will affect the heart * If receiving bevacizumab will have any effect on how patients recover from surgery * Side effects of the combinations of drugs used in this study

Key Dates

First listed
Aug 17, 2006
Start date
Aug 31, 2006
Status verified
Mar 2020
Primary completion
Feb 29, 2008
Completion
Nov 30, 2009

Study Design

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

Arms

  • Experimental: Doxorubicin+Cyclophosphamide+Bevacizumab

Primary Outcome Measure

Pathologic Complete Response (pCR) in the Breast [ Time Frame: Approximately 7 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
NSABP Foundation, Inc.PittsburghPennsylvania15212-

Find similar trials in Pittsburgh, PA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
NSABP Foundation, Inc.· Pittsburgh, PA

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