A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT02005549
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab [Avastin] — DRUG
    15 mg/kg iv on Day 1 of each 3-week cycle, 5 cycles
  • docetaxel — DRUG
    75 mg/m2 on Day 1 of each 3-week cycle, 6 cycles
  • capecitabine [Xeloda] — DRUG
    950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, every 3 weeks

Study Details

This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months.

Key Dates

First listed
Dec 9, 2013
Start date
Feb 28, 2006
Status verified
May 2014
Primary completion
Apr 30, 2008
Completion
Apr 30, 2008

Study Design

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

Arms

  • Experimental: Neoadjuvant Therapy

Primary Outcome Measure

Percentage of Participants With Pathological Complete Response (pCR) [ Time Frame: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18]) ]

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