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)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: bevacizumab [Avastin]; Drug: paclitaxel

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm	Drug: bevacizumab [Avastin]; 10 mg/kg iv every 2 weeks or 15 mg/kg iv every 3 weeks; Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety profile: Adverse events	approximately 2 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: July 2, 2010
• First Submitted That Met QC Criteria: July 2, 2010
• First Posted (Estimate): July 5, 2010

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Paclitaxel; Bevacizumab
• Other Study ID Numbers: ML25081