A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer.

Sponsor
Hoffmann-La Roche
Study ID
NCT00717405
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Standard chemotherapy — DRUG
    As prescribed
  • bevacizumab [Avastin] — DRUG
    15mg/kg iv 3 weekly in cycles 1-8
  • trastuzumab [Herceptin] — DRUG
    8mg/kg iv loading dose followed by 6mg/kg iv 3 weekly in cycles 5-8.

Study Details

This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Key Dates

First listed
Jul 17, 2008
Start date
Oct 31, 2008
Status verified
Jul 2016
Primary completion
Apr 30, 2010
Completion
Oct 31, 2014

Study Design

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

Arms

  • Experimental: 1

Primary Outcome Measure

Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification [ Time Frame: From baseline through Week 25 (Up to 6 months) ]

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