Clinical trial NCT00846027: A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-02-18
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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).

Primary outcomes:
measure: Progression-free Survival
timeFrame: Baseline to the end of the study (up to 2 years 10 months)
Secondary outcomes:
measure: Percentage of Participants With an Objective Response
timeFrame: Baseline to the end of the study (up to 2 years 10 months)
measure: Duration of the Objective Response
timeFrame: Baseline to the end of the study (up to 2 years 10 months)
measure: Overall Survival
timeFrame: Baseline to the end of the study (up to 2 years 10 months)
Other outcomes:
Locations:
city: Elda
country: Spain
state: Alicante
city: Manresa
country: Spain
state: Barcelona
city: Cádiz
country: Spain
state: Cadiz
city: Las Palmas de Gran Canaria
country: Spain
state: Las Palmas
city: Alcorcon
country: Spain
state: Madrid
city: Marbella
country: Spain
state: Malaga
city: Vigo
country: Spain
state: Pontevedra
city: Sagunto
country: Spain
state: Valencia
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Burgos
country: Spain
city: Cordoba
country: Spain
city: Granada
country: Spain
city: Granada
country: Spain
city: Huelva
country: Spain
city: Jaen
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: