Randomized Study to Assess the Efficacy of a Further 5 Years of Anastrozole Treatment for Postmenopausal Women with Breast Cancer Completing 5 Years Anastrozole Containing Adjuvant Endocrine Therapy

INTERVENTION: CONTINUE arm: continuation of Anastrozole for 5 years (1 mg/day po QD) STOP arm: no‐treatment (no additional medication) for 5 years CONDITION: Hormone‐responsive postmenopausal primary breast cancer PRIMARY OUTCOME: Disease‐Free Survival SECONDARY OUTCOME: Overall Survival; Distant Disease‐Free Survival; Adverse Events; Health Related Quality of Life: HRQOL; Cost‐Effectiveness (QALY) INCLUSION CRITERIA: 1)Post operative primary breast cancer proven histologically to be invasive breast cancer. Postmenopause at the randomization. The requirement for menopause is to fulfill at least one of following; a)Age>=55, b)Age>=45 and no menstruation for more than 2 years, c)Bilateral ovariectomy. 2)Patient with no usage ofLH‐RHa for adjuvant endocrine therapy, and satisfy one of following; a)taking Anastrozole for 5 years as first line chemotherapy, b)Tamoxifen for 2 to 3 years as 1st line chemotherapy, and followed Anastrozole for 2 to 3 years, namely adjuvant endocrine chemotherapy for 5 years. 3)Clinical stage of T1 to T3, N0 to N2, M0 at the first medical examination(operation). 4)At least one of hormone receptor tests(estrogen receptor, progesterone receptor) is positive. 5)Performance status(ECOG) of 0 to 1. 6)Age at randomization <=80. 7)No relapse and contralateral breast cancer during 6 months before randomization.

Epistemonikos ID: 88f5af953aaa716eeae9c4dec721de5aed0e8b2c
First added on: Aug 21, 2024