A Study of The Safety Profile of First-line Avastin (Bevacizumab) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Her2-negative Breast Cancer (AVATAX)

Sponsor
Hoffmann-La Roche
Study ID
NCT01156961
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab [Avastin] — DRUG
    10 mg/kg iv every 2 weeks or 15 mg/kg iv every 3 weeks
  • paclitaxel — DRUG
    90 mg/m2 iv days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 iv day 1 of each 21-day cycle

Study Details

This single arm, open label study will assess the safety profile of Avastin (bevacizumab) in combination with paclitaxel as first-line treatment in patients with locally recurrent or metastatic Her2-negative breast cancer. Patients will receive Avastin, either 10 mg/kg intravenously (iv) every 2 weeks or 15 mg/kg iv every 3 weeks. Correspondingly, paclitaxel will be administered at a dose of 90 mg/m2 o days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 on day 1 of every 21-day cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Key Dates

First listed
Jul 5, 2010
Start date
Oct 31, 2010
Status verified
Nov 2016
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012

Study Design

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

Arms

  • Experimental: Single Arm

Primary Outcome Measure

Safety profile: Adverse events [ Time Frame: approximately 2 years ]

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