Trastuzumab in Treating Women With Primary Breast Cancer

Breast Cancer Clinical Trial

Official title: HERA: A Randomised Three-Arm Multi-Centre Comparison Of 1 Year And 2 Years Of Herceptin Versus No Herceptin In Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy

Status Active, not recruiting

Clinical Trial Summary

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether trastuzumab is effective in treating primary breast cancer in women who have completed adjuvant chemotherapy.

PURPOSE: This randomized phase III trial is studying two different regimens of trastuzumab and observation only to compare how well they work in treating women with breast cancer.

Clinical Trial Description

OBJECTIVES:

Primary

• Compare the disease-free survival of women with HER2-positive primary breast cancer treated with trastuzumab (Herceptin®) for 1 year vs trastuzumab for 2 years vs standard supportive care.

• Compare the overall survival of patients treated with these regimens.

• Compare the relapse-free survival of patients treated with these regimens.

• Compare the distant disease-free survival of patients treated with these regimens.

• Compare the incidence of cardiac dysfunction in patients treated with these regimens.

• Evaluate the safety and tolerability of these regimens in these patients.

Secondary

• Compare time to recurrence in patients treated with these regimens.

• Compare time to distant recurrence in patients treated with these regimens.

• Compare outcomes, in terms of disease-free survival, overall survival, recurrence-free survival, distant disease-free survival, time to recurrence, time to distant recurrence, cardiac safety, and overall safety, in patients treated with trastuzumab for 1 year vs 2 years.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to nodal status (any nodal status and prior neoadjuvant chemotherapy vs no positive nodes and no prior neoadjuvant chemotherapy vs 1-3 positive nodes and no prior neoadjuvant chemotherapy vs 4 or more positive nodes and no prior neoadjuvant chemotherapy), prior adjuvant chemotherapy regimen (no anthracyclines or taxanes vs anthracyclines only vs anthracyclines and taxanes), receptor status and endocrine therapy (negative vs positive and no prior endocrine therapy vs positive and prior endocrine therapy), age (18 to 34 vs 35 to 49 vs 50 to 59 vs 60 and over), and participating center. Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive trastuzumab (Herceptin®) IV over 1.5 hours on day 1. Courses repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

• Arm II: Patients receive trastuzumab as in arm I. Courses repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

• Arm III: Patients receive no trastuzumab. Patients may later receive trastuzumab as in arm I or arm II.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 4,482 patients (1,494 per treatment arm) will be accrued for this study within 4 years. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00045032
• Study type: Interventional
• Source: Hoffmann-La Roche
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 2001
• Completion date: September 2015