BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab

Summary

The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer.

Conditions

• Breast Cancer

Interventions

DRUG

Docetaxel

75 mg/m2 IV on day 1 every 3 weeks for cycles 1-6, Arms 1A and 1B 100 mg/m2 on day 1 every 3 weeks for cycles 1-3, Arms 2A and 2B

DRUG

Trastuzumab

First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-6. Following completion of chemotherapy cycles: 6 mg/kg IV every 3 weeks until 1 year following first trastuzumab dose. Arms 1A and 1B First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-3. 21 days after last dose of FEC: 8 mg/kg IV first post-FEC dose only; subsequent doses 6 mg/kg IV every 3 weeks for a total of 1 year. Arms 2A and 2B

DRUG

Carboplatin

6 mg/ml/min IV on day 1 every 3 weeks for cycles 1-6

DRUG

Bevacizumab

15 mg/kg IV on day 1 every 3 weeks for cycles 1-6. Following completion of chemotherapy cycles: 15 mg/kg IV on day 1 every 3 weeks until 1 year following first bevacizumab dose. Arm 1B 15 mg/kg IV on day 1 every 3 weeks for cycles 1-3. 21 days after the last dose of FEC: 15 mg/kg IV on day 1 every 3 weeks until 1 year following first bevacizumab dose. Arm 2B

DRUG

5-Fluorouracil

600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6

DRUG

Epirubicin

90 mg/m2 IV on day 1 every 3 weeks for cycles 4-6

DRUG

Cyclophosphamide

600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6

Sponsors & Collaborators

• Cancer International Research Group (CIRG)

  collaborator OTHER

• Hoffmann-La Roche

  collaborator INDUSTRY

• Genentech, Inc.

  collaborator INDUSTRY

• NSABP Foundation Inc

  lead NETWORK

Principal Investigators

• Norman Wolmark, MD · NSABP Foundation Inc

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2013-06-30

Completion

2014-07-31

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Bosnia and Herzegovina
• Brazil
• Bulgaria
• Canada
• Chile
• China
• Croatia
• Czechia
• Egypt
• Estonia
• France
• Germany
• Greece
• Hong Kong
• Hungary
• Ireland
• Israel
• Italy
• Latvia
• Mexico
• Peru
• Philippines
• Poland
• Portugal
• Romania
• Russia
• Serbia
• Slovenia
• South Africa
• South Korea
• Spain
• Sweden
• Taiwan
• Thailand
• United Kingdom

Study Locations