CSP (Comprehensive Support Project)

CSPOR

N-SAS BC 02

Comparison of 4 Cycles of Anthracycline and Cyclophosphamide (AC) followed by 4 Cycles of Taxane (ACT) versus 8 Cycles of Taxane and Comparison of Paclitaxel versus Docetaxel

Study design

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

Trial schema

Trial schema

Objectives

  1. To verify whether 8 cycles of a taxane is equivalent (non-inferior) to 4 cycles of AC plus 4 cycles of a taxane in terms of survival
  2. To compare disease-free survival and overall survival between docetaxel 75 mg/m2 and paclitaxel 175 mg/m2
  3. To compare health-related QOL (HRQOL), adverse events, and medical cost-effectiveness between 8 cycles of a taxane and 4 cycles of AC followed by 4 cycles of a taxane
  4. To compare HRQOL, adverse events, and medical cost-effectiveness between docetaxel 75 mg/m2 and paclitaxel 175 mg/m2

Primary endpoint: Disease-free survival (DFS)

Secondary endpoints: Progression-free survival (PFS), overall survival (OS), HRQOL, adverse events, and medical cost-effectiveness

Scheduled number of patients and study period

Planned sample size: A total of 1200 patients (300 per group).
Enrollment period: from December 2001 through May 2006.
Follow-up: 10 years (after enrollment of the last patient).

Clinical trial registration

Registered trial number: UMIN C000000055

Protocol

protocol

Presentations at medical conferences

Edema
December 2009: San Antonio Breast Cancer Symposium, Poster: P2090
Results of interim analysis and adverse events
May 2009: American Society of Clinical Oncology (ASCO), Poster: P516
Results of interim analysis and adverse events
December 2008: San Antonio Breast Cancer Symposium, Poster: P4103
Neurotoxicity: Evaluation scale validity and results
May 2006: American Society of Clinical Oncology (ASCO), Poster: P8523
Neurotoxicity: Evaluation scale validity
December 2004: San Antonio Breast Cancer Symposium

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