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)

This study has been withdrawn prior to enrollment.
(Absence of patient's recruitment in the study due to administrative reasons)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01156961
First received: July 2, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This single arm, open label study will assess the safety profile of Avastin (bev acizumab) in combination with paclitaxel as first-line treatment in patients wit h locally recurrent or metastatic Her2-negative breast cancer. Patients will rec eive Avastin, either 10 mg/kg intravenously (iv) every 2 weeks or 15 mg/kg iv ev ery 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-d ay cycle. Anticipated time on study treatment is until disease progression or un acceptable toxicity occurs.


Condition Intervention Phase
Breast Cancer
Drug: bevacizumab [Avastin]
Drug: paclitaxel
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety profile: Adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156961

Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01156961     History of Changes
Other Study ID Numbers: ML25081
Study First Received: July 2, 2010
Last Updated: August 4, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014