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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846027
• Other study ID #: ML21999
• Secondary ID: 2008-003657-32
• Status: Completed
• Phase: Phase 2
• First received: February 17, 2009
• Last updated: July 9, 2014
• Start date: January 2009
• Est. completion date: January 2013

Study information

• Verified date: July 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Espanola del Medicamento
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Bevacizumab
Bevacizumab was supplied as a sterile liquid in glass vials.
• Paclitaxel
Paclitaxel was supplied as a sterile liquid in glass vials.
• Gemcitabine
Gemcitabine was supplied as a sterile liquid in glass vials.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No