Abstract OT1-04-01: Adjuvant ovarian suppression plus aromatase inhibitor or tamoxifen for hormone receptor-positive breast cancer in women younger than 35 (ASPAIT): A multicenter randomized clinical trial

• DOI: 10.1158/1538-7445.sabcs19-ot1-04-01
• Publication Date: 2020-03-26T21:14:22Z
• Authors: Zhen Shan; Nan Shao; Zhongyu yuan; Qianjun Chen; Anqin Zhang; Kun Wang; Ailing Zhang; Li Cai; Yuhua Song; Herui Yao; Hongmin Ma; Heng Huang; Jianwen Li; Yuanqi Zhang; Lehong Zhang; Jincai Zhong; Hui Liu; Zhiyong Wu; Li Zhao; Feihai Ling; Weixiong Yang; Rui Zhuo; Xiangyang Song; Ying Lin
• Keywords: Exemestane; Aromatase inhibitor

Abstract In SOFT study, subgroup analysis for hormone receptor-positive (HR+) breast cancer women younger than 35 years indicated better 5-year DFS in OFS+exemestane arm OFS+tamoxifen. Since only about 11% of included were age, this result is underpowered. addition, there still no specific randomized clinical trial focusing on endocrine treatment age. The purpose study to compare the efficacy gonadotropin releasing agonists (GnRHa)+tamoxifen versus GnRHa+AIs HR+ early patients under age with intermediate or high risk disease recurrence. Study design This a prospective, open label, multicentre, controlled that compared GnRHa+tamoxifen was initiated by first affiliated hospital Sun Yat-sen university 2016. Twenty-four hospitals China participate trial. protocol approved appropriate regulatory and ethics authorities each centre. has been registrated at ClinicalTrials.gov. NCT Number NCT02914158. Criteria patient eligibility: 1. Written informed consent must be signed. 2. ECOG≤2. 3. Histologically proven (ER≥1% IHC) invasive cancer. 4. Age≤35, premenopausal. 5. No distant metastatic disease. 6. T≥2cm least 1 axillary lymph node involved. 7. Patient accept proper surgery, systemic therapy radiation if necessary. 8. Laboratory exam criteria enrollment: hemoglobin ≥10g/dl, white blood cell ≥4,000/mm3, platelets ≥100,000/mm3, glutamic oxalacetic transaminase, glutamic-pyruvic alkaline phosphatase ≤2 times upper limit normal (ULN), total bilirubin, creatinine clearance rate ≤1.5 ULN. ineligibility: Patients who are pregnant lactating time randomization refuse contraception.2. received organ transplantation. have other malignant diseases within 5 years. psychiatric disorder, peripheral central nerve system any which compromises ability give study. sever hepatic, renal, cardiovascular, respiratory, digestive uncontrolled diabetes. trials. allergy goserelin, leuprorelin, tamoxifen AIs. Statistical According previous results, OFS+tamoxifen recurrence 73% vs. 81% OFS+AIs. designed 80% power detect between-group difference using two-sample log-rank test (two-sided a=0.05). To allow missing 10% data, planned enroll 680 (340 group) statistical assumed 197 primary end point events should occur during follow-up OFS+AIs decrease 30% relative risk. calculations performed PASS 11. Treatment details enrolled 1:1 two arms 8 weeeks after adjuvant chemotherapy therapy. Goserelin 3.6mg leuprorelin 3.75mg injected subcutaneously every 28 days Arm A: Tamoxifen 20mg orally daily. B: Exemestane 25mg, letrozole 2.5mg anastrozole 1mg Stratification Stratified HER2 status. Primary point: Disease free survival. Secondary Overall Invasive Breast Cancer Recurrence-Free Interval. Adverse Effects Rate. Citation Format: Zhen Shan, Nan Shao, Zhongyu yuan, Qianjun Chen, Anqin Zhang, Kun Wang, Ailing Li Cai, Yuhua Song, Herui Yao, Hongmin Ma, Heng Huang, Jianwen Li, Yuanqi Lehong Jincai Zhong, Hui Liu, Zhiyong Wu, Zhao, Feihai Ling, Weixiong Yang, Rui Zhuo, Xiangyang Ying Lin. Adjuvant ovarian suppression plus aromatase inhibitor (ASPAIT): A multicenter [abstract]. In: Proceedings 2019 San Antonio Symposium; Dec 10-14; Antonio, TX. Philadelphia (PA): AACR; Res 2020;80(4 Suppl):Abstract nr OT1-04-01.