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Clinical Trials/NCT01156961
NCT01156961
Withdrawn
Phase 4

Post Registration Observational Program for Patients With Locally Recurrent or Metastatic Breast Cancer Who Receive Bevacizumab (Avastin) in Combination With Paclitaxel for the First-line Treatment

Hoffmann-La Roche0 sitesOctober 2010

Overview

Phase
Phase 4
Intervention
bevacizumab [Avastin]
Conditions
Breast Cancer
Sponsor
Hoffmann-La Roche
Primary Endpoint
Safety profile: Adverse events
Status
Withdrawn
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
December 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patients, \>/= 18 years of age
  • Locally recurrent or metastatic Her2-negative breast cancer
  • Locally recurrent disease must not be amenable to radiation therapy or resection with curative intent
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Prior Adjuvant chemotherapy allowed; if taxane-based a disease-free interval after completion of \>/=12 months is required
  • Adequate haematological, renal and liver function

Exclusion Criteria

  • Previous chemotherapy for locally recurrent or metastatic disease
  • Radiation therapy for metastatic disease (except for relief of metastatic bone pain with irradiation of \</= 30% of marrow-bearing bone)
  • CNS metastases
  • Pre-existing peripheral neuropathy
  • Clinically significant cardiovascular disease

Arms & Interventions

Single Arm

Intervention: bevacizumab [Avastin]

Single Arm

Intervention: paclitaxel

Outcomes

Primary Outcomes

Safety profile: Adverse events

Time Frame: approximately 2 years

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