CSPOR

N-SAS BC 07

Evaluation of trastuzumab without chemotherapy as a postoperative adjuvant therapy in HER2 positive elderly breast cancer patients: Randomized controlled trial

Study Design

This is a multicenter, collaborative, open-label, randomized, parallel-group, controlled study.

Trial Schema

Objectives

To compare trastuzumab (Herceptin®) alone (H group) with a combination of trastuzumab and chemotherapy (H + CT group) in a randomized, controlled study of postoperative adjuvant therapy in women 70 years or older who have human epidermal growth factor receptor type-2 (HER2)-positive primary breast cancer, and thereby clarify the clinical positioning of these treatments.

Primary endpoint: Disease-free survival

Secondary endpoints: Overall survival, recurrence-free survival, adverse events, health-related quality of life (HRQOL), comprehensive functional evaluation in the elderly, and cost-effectiveness (utility).

Scheduled number of patients and study period

Planned sample size: A total of 300 patients (150 per group).
Enrollment period: from October 2009 through October 2013.
Follow-up: 3 years (after enrollment of the last patient).

Clinical trial registration

Registered trial number: UMIN 000002349,
ClinicalTrials.gov NCT01104935

Presentations at medical conferences

Study design

October 2010: ASCO Breast Cancer Symposium
Poster: P60159

Medical papers

Study design: Jpn J Clin Oncol doi:10.1093/jjco/hyr011, 2011

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