A Randomized Three-Arm, Multicenter 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
A Randomized Three-Arm, Multicenter 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
The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.
Inclusion Criteria:
Exclusion Criteria:
Buenos Aires, Buenos Aires 1118, Argentina
Geelong, Australian Capital Territory 3220, Australia
Feldkirch-Tisis, 6807, Austria
Linz Donau, A-4010, Austria
Kelowna, British Columbia V1Y 5L3, Canada
Surrey, British Columbia V3V 1Z2, Canada
Victoria, British Columbia V8R 6V5, Canada
Charlottetown, Prince Edward Island C1A 8T5, Canada
Magdeburg, D-39120, Germany
Shatin, New Territories, Hong Kong
Lisbon, 1099-023 Codex, Portugal
Vigo Pontevedra, 36204, Spain
Epping Essex, England CM16 6TN, United Kingdom
Newcastle upon Tyne, England NE4 6BE, United Kingdom
West Yorkshire, England BD20 6TD, United Kingdom