A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer
NCT07349069 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5500
Last updated 2026-05-22
Summary
The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer.
Conditions
Interventions
- DRUG
-
HRS-8080 Tablets
HRS-8080 tablets.
- DRUG
-
Letrozole tablets
Letrozole tablets.
- DRUG
-
Tamoxifen Citrate Tablets
Tamoxifen Citrate tablets.
- DRUG
-
Anastrozole Tablets
Anastrozole tablets.
- DRUG
-
Exemestane tablets
Exemestane tablets.
Sponsors & Collaborators
-
Shandong Suncadia Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-04
- Primary Completion
- 2030-12-31
- Completion
- 2034-01-31
Countries
- China
Study Locations
More Related Trials
-
Letrozole in Treating Breast Cancer in Postmenopausal Women With Stage I, II, or III Breast Cancer Previously Treated With Tamoxifen (GIM4)
NCT01064635 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Letrozole in Preventing Breast Cancer in Postmenopausal Women
NCT00090857 ·Status: COMPLETED ·Phase: PHASE2
-
Letrozole After Tamoxifen in Treating Women With Breast Cancer
NCT00003140 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity
NCT05128773 ·Status: TERMINATED ·Phase: PHASE3
-
Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer
NCT00553410 ·Status: COMPLETED ·Phase: PHASE3
-
Phase III, Randomized, Double Blind Trial Low Dose Tamoxifen Versus Placebo in Hormone Replacement Therapy (HRT) Users
NCT01579734 ·Status: UNKNOWN ·Phase: PHASE3
-
Efficacy of Tamoxifen Versus Toremifene in CYP2D6 IM/PM of Premenopausal Patients With ER-positive Early Breast Cancer
NCT03351062 ·Status: RECRUITING ·Phase: PHASE3
-
Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women
NCT02914158 ·Status: RECRUITING ·Phase: PHASE3
-
The Performance of Patient Support Program in Early Stage Breast Cancer
NCT00769080 ·Status: COMPLETED
-
Letrozole in Preventing Breast Cancer in Healthy Postmenopausal Women at High Risk for Breast Cancer
NCT01077453 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
NCT02278120 ·Status: COMPLETED ·Phase: PHASE3
-
Comparative Evaluation of Efficacy and Safety of Toremifene, Tamoxifen, and Aromatase Inhibitor Plus Ovarian Function Suppression in Hormone Receptor-Positive Early Breast Cancer Among Non-Low-Risk Premenopausal Women: A Real-World Study
NCT05801705 ·Status: UNKNOWN
-
Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
NCT00332852 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Breast Cancer Prevention by Letrozole in High Risk Women
NCT00579826 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer
NCT05780567 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c Versus Placebo in Combination With Letrozole or Anastrozole ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer.
NCT05439499 ·Status: UNKNOWN ·Phase: PHASE3
-
A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)
NCT04961996 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer
NCT00796107 ·Status: TERMINATED ·Phase: PHASE2
-
Study Of MK-0752 In Combination With Tamoxifen Or Letrozole to Treat Early Stage Breast Cancer
NCT00756717 ·Status: COMPLETED ·Phase: PHASE4
-
Letrozole in Treating Postmenopausal Women With Stage I, II or III Breast Cancer That Can Be Removed by Surgery
NCT00651976 ·Status: TERMINATED ·Phase: EARLY_PHASE1
-
Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer
NCT00280930 ·Status: UNKNOWN ·Phase: PHASE2
-
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
NCT03176238 ·Status: COMPLETED ·Phase: PHASE3
-
A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Trastuzumab Emtansine (T-DM1) With or Without Standard Endocrine Therapy vs. Trastuzumab With Standard Endocrine Therapy Given for Twelve Weeks in Patients With Operable HER2+/HR+ Breast Cancer Within the ADAPT Protocol.
NCT01745965 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Tolerability of Toremifene or Tamoxifen Therapy in Premenopausal Estrogen and Progesterone Receptor Positive Breast Cancer Patients
NCT02132000 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Letrozole and Lapatinib Followed by Everolimus in Women With Advanced Breast Cancer
NCT01499160 ·Status: TERMINATED ·Phase: PHASE2