A Study of Avastin (Bevacizumab) and Sequential Chemotherapy in Patients With Primary HER2 Negative Operable Breast Cancer.

Sponsor
Hoffmann-La Roche
Study ID
NCT00559754
Phase
PHASE2
Status
Completed

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
  • Standard chemotherapy — DRUG
    As prescribed

Study Details

This single arm study will assess the efficacy and safety of a combination of Avastin and docetaxel following cyclophosphamide and doxorubicin, in patients with HER2 negative operable breast cancer. Patients will receive 4 x 3 week cycles of chemotherapy with doxorubicin (60mg/m2 iv on day 1 of each cycle) and cyclophosphamide (600mg/m2 iv on day 1 of each cycle). They will then receive 4 x 3 week cycles of docetaxel (75mg/m2 on day 1 of each cycle) in combination with Avastin (15mg/kg on day 1 of each cycle). 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
Dec 31, 2007
Status verified
Nov 2014
Primary completion
Sep 30, 2010
Completion
Sep 30, 2010

Study Design

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

Arms

  • Experimental: 1

Primary Outcome Measure

Percentage of Participants With Pathological Complete Response (pCR) [ Time Frame: After Week 24 (surgery) ]

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