A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 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: July 9, 2014
Last verified: July 2014
  Purpose

This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel 150 mg/m^2 iv, and gemcitabine 200 mg/m^2 iv on Day 1 and Day 15 of each 4-week treatment cycle until disease progression, death, or withdrawal of consent.


Condition Intervention Phase
Breast Cancer
Drug: Bevacizumab
Drug: Paclitaxel
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: 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: Baseline to the end of the study (up to 2 years 10 months) ] [ Designated as safety issue: No ]
    Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.


Secondary Outcome Measures:
  • Percentage of Participants With an Objective Response [ Time Frame: Baseline to the end of the study (up to 2 years 10 months) ] [ Designated as safety issue: No ]
    An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.

  • Duration of the Objective Response [ Time Frame: Baseline to the end of the study (up to 2 years 10 months) ] [ Designated as safety issue: No ]
    Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.

  • Overall Survival [ Time Frame: Baseline to the end of the study (up to 2 years 10 months) ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from the first dose of study medication until death.


Enrollment: 90
Study Start Date: January 2009
Study Completion Date: January 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab + paclitaxel + gemcitabine
Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
Drug: Bevacizumab
Bevacizumab was supplied as a sterile liquid in glass vials.
Other Name: Avastin
Drug: Paclitaxel
Paclitaxel was supplied as a sterile liquid in glass vials.
Other Name: Taxol
Drug: Gemcitabine
Gemcitabine was supplied as a sterile liquid in glass vials.
Other Name: Gemzar

  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.
  • HER-2 negative disease.
  • Candidates for chemotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 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 enrollment.
  • Chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (> 325 mg/day) or clopidogrel (> 75mg/day).
  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: 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
Results First Received: May 27, 2014
Last Updated: July 9, 2014
Health Authority: Spain: Agencia Espanola del Medicamento

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

ClinicalTrials.gov processed this record on September 18, 2014