Phase III Randomized Adjuvant Study of Tamoxifen Alone Versus Sequential Tamoxifen and Anastrozole in Hormone-Responsive Postmenopausal Breast Cancer Patients

Authors
Category Primary study
JournalUMIN Clinical Trials Registry
Year 2005
INTERVENTION: TAM:Tamoxifen alone (total 5 years) ANA:Sequential Tamoxifen and Anastrozole (change after registration, total 5 years) CONDITION: Hormone‐responsive postmenopausal primary breast cancer PRIMARY OUTCOME: Disease‐Free Survival; Adverse Events SECONDARY OUTCOME: Relapse‐Free Survival; Overall Survival; Health‐Related QOL; Efficacy of medical economy INCLUSION CRITERIA: (1)Histologically proven invasive breast cancer, postoperative primary breast cancer, postmenopausal before registration (Postmenopausal is defined as (a)age>=60, (b)age>=45, amenorrhea more than 1 year without hysterectomy or (c)double ovariectomy has done. The case which is premenopausal before operation and menopaused after chemotherapy or during Tamoxifen administration will be included.) (2)StageI,IIA,IIB,IIIA,IIIB (TNM staging system) (3)(a)node dissection has done or (b) sentinel node biopsy has performed and diagnosis on H&E is negative (4)The result of hormone receptor test meets (a)‐(c). (a)estrogen receptor(+) and progesterone receptor(+),(b)estrogen receptor(+) and progesterone receptor(‐),(c)estrogen receptor(‐) and progesterone receptor(+) (Take priority over the result of immune staining to EIA) (5)Taken Tamoxifen as postoperative adjuvant therapy for 1‐4 years (need good compliance of patient) (6)PS(ECOG) 0,1 (
Epistemonikos ID: 098da57a1f12eb4e52de2302e038d3f4f5ed483f
First added on: Aug 21, 2024