A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.

NCT ID: NCT00576901

Last Updated: 2014-08-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-06-30

Brief Summary

This single arm study will assess the efficacy and safety of combination first-line treatment with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2 p.o. on days 1-15 of each cycle). Four cycles of chemotherapy are planned, plus an optional additional two cycles; after chemotherapy patients will be assessed for surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type: DRUG

15mg/kg iv on day 1 of each 3 week cycle

Docetaxel

Intervention Type: DRUG

75mg/m2 iv on day 1 of each 3 week cycle

Xeloda

Intervention Type: DRUG

2000mg/m2 po on days 1-15 of each 3 week cycle

Interventions

bevacizumab [Avastin]

15mg/kg iv on day 1 of each 3 week cycle

Intervention Type: DRUG

Docetaxel

75mg/m2 iv on day 1 of each 3 week cycle

Intervention Type: DRUG

Xeloda

2000mg/m2 po on days 1-15 of each 3 week cycle

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• female patients, >=18 years of age;
• HER2-negative, locally advanced (stage II or III) or inflammatory cancer of the breast;
• ECOG performance status 0-1.

Exclusion Criteria

• metastatic disease (stage IV);
• previous treatment for breast cancer;
• evidence of CNS metastasis;
• current or recent (within 10 days of first dose of Avastin) use of aspirin (>325mg/day) NSAIDs or full dose anticoagulants for therapeutic purposes;
• clinically significant cardiovascular disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

ML20561

Identifier Type: -

Identifier Source: org_study_id