A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.

Sponsor
Hoffmann-La Roche
Study ID
NCT00576901
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab [Avastin] — DRUG
    15mg/kg iv on day 1 of each 3 week cycle
  • Docetaxel — DRUG
    75mg/m2 iv on day 1 of each 3 week cycle
  • Xeloda — DRUG
    2000mg/m2 po on days 1-15 of each 3 week cycle

Study Details

This single arm study will assess the efficacy and safety of combination first-line treatment with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2 p.o. on days 1-15 of each cycle). Four cycles of chemotherapy are planned, plus an optional additional two cycles; after chemotherapy patients will be assessed for surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Key Dates

First listed
Dec 19, 2007
Start date
Nov 30, 2007
Status verified
Jul 2014
Primary completion
Jun 30, 2009
Completion
Jun 30, 2009

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Percentage of Participants Achieving Pathological Complete Response (pCR) [ Time Frame: At time of surgery, after receiving up to 6 cycles of treatment (average of 12 to 18 weeks) ]

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