A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Gemcitabine

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • 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, 41014
  • Sevilla, Spain, 41009
  • Zaragoza, Spain, 50009
  • Alicante
    • Elda, Alicante, Spain, 03600
  • Barcelona
    • Manresa, Barcelona, Spain, 08243
  • Cadiz
    • Cádiz, Cadiz, Spain, 11009
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
  • Malaga
    • Marbella, Malaga, Spain, 29600
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36214
  • Valencia
    • Sagunto, Valencia, Spain, 46520

Participation Criteria

Eligibility Criteria

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

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Avastin; Drug: Paclitaxel; Paclitaxel was supplied as a sterile liquid in glass vials.; Other Names: Taxol; Drug: Gemcitabine; Gemcitabine was supplied as a sterile liquid in glass vials.; Other Names: Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival	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.	Baseline to the end of the study (up to 2 years 10 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an Objective Response	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.	Baseline to the end of the study (up to 2 years 10 months)
Duration of the Objective Response	Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.	Baseline to the end of the study (up to 2 years 10 months)
Overall Survival	Overall survival is defined as the time from the first dose of study medication until death.	Baseline to the end of the study (up to 2 years 10 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: February 17, 2009
• First Submitted That Met QC Criteria: February 17, 2009
• First Posted (Estimate): February 18, 2009

Study Record Updates

• Last Update Posted (Estimate): July 23, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: July 1, 2014

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; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Gemcitabine; Paclitaxel; Bevacizumab
• Other Study ID Numbers: ML21999; 2008-003657-32 (EudraCT Number)