CSP (Comprehensive Support Project)

CSPOR

N-SAS BC 05

Randomized study to assess the efficacy of a further 5 years of anastrozole treatment for postmenopausal women with breast cancer completing 5 years of anastrozole containing adjuvant endocrine therapy

Study design

A randomized, open-label, phase 3 trial.

Trial Schema

Trial schema

Objectives

  1. To evaluate which group is better regarding DFS.
    Primary endpoint
    Disease-free survival (DFS)
    Secondary endpoints
    Overall survival (OS), distant disease-free survival (DDFS),
    Adverse events, Health-related quality of life (HRQOL), Cost-effectiveness
    Other variables
    Bone mineral density (BMD), joint symptoms
  2. To establish and expand information networks enabled by the participation of general practitioners specializing in breast cancer in clinical trials.

Scheduled number of patients and study period

Planned sample size: A total of 2500 patients (1250 per group).
Enrollment period: from November 2007 through November 2012.
Follow-up: 5 years (after enrollment of the last patient).

Clinical trial registration

Registered trial number: UMIN 000000818

Presentations at medical conferences

Baseline assessment of patient-reported outcomes (PROs)
March 2011: 12th St. Gallen International Breast Cancer Conference,
Poster: P284

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