A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT00559845
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • 5-fluorouracil — DRUG
    600 milligrams per meter squared (mg/m\^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles.
  • Epidoxorubicin — DRUG
    90 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
  • Cyclophosphamide — DRUG
    600 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
  • Paclitaxel — DRUG
    Paclitaxel was administered at 80 mg/m\^2 i.v. over 1 hour weekly for 12 weeks.
  • Bevacizumab — BIOLOGICAL
    Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles.

Study Details

This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. Participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Key Dates

First listed
Nov 16, 2007
Start date
Feb 29, 2008
Status verified
Oct 2016
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015

Study Design

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

Arms

  • Experimental: Bevacizumab
    Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.

Primary Outcome Measure

Percentage of Participants With Pathological Complete Response Following Principle Investigator Review [ Time Frame: Up to 7.5 years ]

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