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 (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT01156961
• Collaborator: (none)
• Enrollment: 0
• Arm: 1
• Duration (Months): 26

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: bevacizumab [Avastin]; Drug: paclitaxel	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2012
• Anticipated Study Completion Date: Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety profile: Adverse events [approximately 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01156961
• Other Study ID Numbers: ML25081
• First Posted: Jul 5, 2010
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Breast Neoplasms; Paclitaxel; Bevacizumab

Study Results

No Results Posted as of Nov 2, 2016