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)

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01156961
• Other study ID #: ML25081
• Status: Withdrawn
• Phase: Phase 4
• First received: July 2, 2010
• Last updated: November 1, 2016
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• bevacizumab [Avastin]
10 mg/kg iv every 2 weeks or 15 mg/kg iv every 3 weeks
• paclitaxel
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile: Adverse events		approximately 2 years	No