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

Conditions

• Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Docetaxel — DRUG
  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
• Trastuzumab — DRUG
  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
• Carboplatin — DRUG
  6 mg/ml/min IV on day 1 every 3 weeks for cycles 1-6
• Bevacizumab — DRUG
  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
• 5-Fluorouracil — DRUG
  600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6
• Epirubicin — DRUG
  90 mg/m2 IV on day 1 every 3 weeks for cycles 4-6
• Cyclophosphamide — DRUG
  600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6

Study Details

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.

Key Dates

First listed

Feb 29, 2008

Start date

Apr 30, 2008

Status verified

Mar 2020

Primary completion

Jun 30, 2013

Completion

Jul 31, 2014

Study Design

Enrollment

3,509 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 1A: TCH-H
  Docetaxel (T), Carboplatin (C), and Trastuzumab (H) followed by Trastuzumab (H)
• Experimental: 1B: TCHB-HB
  Docetaxel (T), Carboplatin (C), Trastuzumab (H), Bevacizumab (B) followed by Trastuzumab (T) and Bevacizumab (B)
• Active Comparator: 2A: TH-FEC-H
  Docetaxel (T) and Trastuzumab (H) followed by 5-fluorouracil (F), Epirubicin (E), and Cyclophosphamide (C) followed by Trastuzumab (H)
• Experimental: 2B: THB-FEC-HB
  Docetaxel (T), Trastuzumab (H), and Bevacizumab (B) followed by 5-Fluorouracil (F), Epirubicin (E), and Cyclophosphamide (C) followed by Trastuzumab (H) and Bevacizumab (B)

Primary Outcome Measure

Invasive Disease-free Survival (IDFS) [ Time Frame: up to 10 years ]

Locations (393)

Find similar trials in Birmingham, AL

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