A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer

NCT ID: NCT02005549

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-04-30

Brief Summary

This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months.

Conditions

Breast Cancer

Study Design

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

Study Groups

Neoadjuvant Therapy

Group Type: EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type: DRUG

15 mg/kg iv on Day 1 of each 3-week cycle, 5 cycles

docetaxel

Intervention Type: DRUG

75 mg/m2 on Day 1 of each 3-week cycle, 6 cycles

capecitabine [Xeloda]

Intervention Type: DRUG

950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, every 3 weeks

Interventions

bevacizumab [Avastin]

15 mg/kg iv on Day 1 of each 3-week cycle, 5 cycles

Intervention Type: DRUG

docetaxel

75 mg/m2 on Day 1 of each 3-week cycle, 6 cycles

Intervention Type: DRUG

capecitabine [Xeloda]

950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, every 3 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• female patients, 18-70years of age;
• histologically-proven invasive breast cancer;
• no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;
• no distant disease/secondary cancer.

Exclusion Criteria

• pregnant or lactating women;
• pre-operative local treatment for breast cancer;
• prior or concurrent systemic antitumor therapy;
• clinically significant cardiac disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 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_CHAIR

Hoffmann-La Roche

Locations

Salzburg, , Austria

Countries

Austria

Other Identifiers

ML19869

Identifier Type: -

Identifier Source: org_study_id