A Study of Avastin (Bevacizumab) in Combination With Taxane-Based Chemotherapy as First Line Treatment in Patients With HER2 Negative Breast Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00846027
First received: February 17, 2009
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

This single arm study will assess the efficacy and safety of first line treatment with Avastin in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER2 negative breast cancer. Eligible patients will receive Avastin 10mg/kg iv, paclitaxel 150mg/m2 and gemcitabine 200mg/m2 iv on days 1 and 15 of each 4 week treatment cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.


Condition Intervention Phase
Breast Cancer
Drug: bevacizumab [Avastin]
Drug: paclitaxel
Drug: gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AN OPEN LABEL STUDY TO ASSESS THE EFFECT OF FIRST LINE TREATMENT WITH AVASTIN IN COMBINATION WITH PACLITAXEL AND GEMCITABINE IN PROGRESSION-FREE SURVIVAL IN PATIENTS WITH HER-2 NEGATIVE BREAST CANCER

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Event driven; tumor assessments every 3 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best overall survival; overall response; duration of response; [ Time Frame: Event driven; tumor assessments every 3 cycles ] [ Designated as safety issue: No ]
  • Adverse events; laboratory parameters [ Time Frame: Throughout study, at each clinic visit ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: February 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
10mg/kg iv on days 1 and 15 of each 4 week cycle
Drug: paclitaxel
150mg/m2 iv on days 1 and 15 of each 4 week cycle
Drug: gemcitabine
200mg/m2 iv on days 1 and 15 of each 4 week cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female patients, >=18 years of age;
  • breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only;
  • HER2-negative disease;
  • candidates for chemotherapy;
  • ECOG PS of <=2;

Exclusion Criteria:

  • previous chemotherapy for metastatic or locally advanced breast cancer;
  • previous radiotherapy for treatment of metastatic breast cancer;
  • any prior adjuvant treatment with anthracyclines completed <6 months prior to enrolment;
  • chronic daily treatment with corticosteroids (>=10mg/day) aspirin (>325mg/day) or clopidogrel (>75mg/day);
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846027

Locations
Spain
Elda, Alicante, Spain, 03600
Manresa, Barcelona, Spain, 08243
Cádiz, Cadiz, Spain, 11009
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Alcorcon, Madrid, Spain, 28922
Marbella, Malaga, Spain, 29600
Vigo, Pontevedra, Spain, 36214
Sagunto, Valencia, Spain, 46520
Barcelona, Spain, 08907
Barcelona, Spain, 08022
Burgos, Spain, 09006
Cordoba, Spain, 14004
Granada, Spain, 18014
Granada, Spain, 18003
Huelva, Spain, 21005
Jaen, Spain, 23007
Lugo, Spain, 27004
Madrid, Spain, 28041
Madrid, Spain, 28222
Murcia, Spain, 30008
Sevilla, Spain, 41009
Sevilla, Spain, 41014
Zaragoza, Spain, 50009
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: NCT00846027     History of Changes
Other Study ID Numbers: ML21999, 2008-003657-32
Study First Received: February 17, 2009
Last Updated: October 28, 2013
Health Authority: Spain:Agencia Espanola del Medicamento

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Bevacizumab
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014