Phase III Randomized Adjuvant Study of Chemotherapy in Node Positive Breast Cancer Patients -AC(Anthracycline-Cyclophosphamide) 4 cycles followed by Taxane 4 cycles (AC-Tac) versus Taxane 8 cycles and Paclitaxel versus Docetaxel-

Phase III Randomized Adjuvant Study of Chemotherapy in Node Positive Breast Cancer Patients -AC(Anthracycline-Cyclophosphamide) 4 cycles followed by Taxane 4 cycles (AC-Tac) versus Taxane 8 cycles and Paclitaxel versus Docetaxel- - Phase III Randomized Adjuvant Study of chemotherapy in Node Positive Breast Cancer Patients (N-SAS BC 02)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000055

Enrollment

1200

Registered

2005-08-12

Start date

2001-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

node positive breast cancer

Interventions

ACP : Adriamycin 60mg/m2 or Epirubicin 75mg/m2 (30min. drip phleboclysis, day1) + Cyclophosphamide 600mg/m2 (60min. drip phleboclysis, day1) 4 cycles followed by Paclitaxel 175g/m2 (3 hours drip ph

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1)Histologically proven primary breast cancer (2)StageI,IIA,IIIB,IIIA (TNM staging system) (3)Proven node positive by node dissection or sentinel node biopsy (4)PS (Eastern Cooperative Oncology Group performance status scale) 0,1 (5)Relations to other treatments are (a)Treatment of this study started within 12 weeks after mastectomy/breast-conserving surgery or node dissection, (b)No postoperative radiation, and (c)No endocrinotherapy, chemotherapy (6)WBC>=4,000 or neutrophilic leukocyte>=2,000, PLT>=100,000,T-B=<1.5 , GPT(ALT)=<(every institution's reference value)*2.5, CRE<=1.5 (these values are tested within 2 weeks before registration for this study), no cardiac infraction or congestive heart failure, no grave ischemic heart disease or valvular disease (7)Written informed consent

Exclusion criteria

Exclusion criteria: (1)During pregnancy or lactation (2)Double invasive carcinoma(less than 5 years after the last treatment) (3)Metachronous bilateral breast cancer (4)Anaphylaxis against medicine using cremophor EL(polyoxethylated castor oil) or polysorbate as a solvent (5)Patients judged inappropriate for this study by the physicians

Design outcomes

Primary

Measure	Time frame
Disease-Free Survival	—

Secondary

Measure	Time frame
Relapse-Free Survival Overall Survival Health-related QOL Adverse Events Efficacy of medical economy	—

Countries

Japan

Contacts

Public ContactAkira Yamao

Public Health Research Foundation Comprehensive Support Project for Clinical Research

support@csp.or.jp03-5287-2633

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026