Exemestane Tablets

DRUG5 trials

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Tolmar Inc., Jiangsu Simcere Pharmaceutical Co., Ltd., Shandong Suncadia Medicine Co., Ltd.

Conditions

Breast CancerCYP2D6 PolymorphismLocally Advanced Breast CancerLocally Advanced or Metastatic Breast CancerMetastatic Breast Cancer

Phase 3

A Study to Evaluate Exemestane Tablets Combined With Ovarian Function Suppression/Ablation in Treatment of Premenopausal Breast Cancer Patients With CYP2D6*10 Mutations （STEP）

Cancer Institute and Hospital, Chinese Academy of Medical SciencesCYP2D6 Polymorphism

Start: 2018-08-09End: 2023-10-30Target: 300Updated: 2018-10-31

Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer

Active, not recruitingNCT04906395

Tolmar Inc.Breast Cancer

Start: 2021-07-01End: 2026-04-30Target: 250Updated: 2026-01-13

Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study

Enrolling by invitationNCT05645536

Tolmar Inc.Breast Cancer

Start: 2022-12-28End: 2028-06-30Target: 250Updated: 2026-01-12

A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)

RecruitingNCT06680921

Jiangsu Simcere Pharmaceutical Co., Ltd.Locally Advanced or Metastatic Breast Cancer

Start: 2024-11-14End: 2028-08-31Target: 460Updated: 2025-09-22

A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer

RecruitingNCT07024173

Shandong Suncadia Medicine Co., Ltd.Locally Advanced Breast Cancer, Metastatic Breast Cancer

Start: 2025-07-23End: 2027-12-01Target: 240Updated: 2026-01-26

Related Papers

SIMRISE: A randomized phase III trial evaluating SIM0270 in combination with everolimus versus treatment of physician’s choice in patients with ER+/HER2- advanced breast cancer, previously treated with CDK4/6 inhibitors.

Journal of Clinical Oncology2025-05-28

Abstract OT3-04-01: A Phase 3 study evaluating ovarian suppression following three-month leuprolide acetate in combination with endocrine therapy in premenopausal subjects with HR+, HER2-negative breast cancer (OVELIA)

Cancer Research2023-03-01

A phase 3, single arm, open-label study evaluating ovarian suppression following 3-month leuprolide acetate for injectable suspension in combination with endocrine therapy in premenopausal subjects with HR+, HER2-negative breast cancer (OVELIA).

Journal of Clinical Oncology2022-06-011 citations