Clinical trial · Observational
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
Comparative Evaluation of Efficacy and Safety of Toremifene, Tamoxifen, and Aromatase Inhibitor Plus Ovarian Suppression in Hormone Receptor-Positive Early Breast Cancer Among Non-Low-Risk Premenopausal Women: A Real-World Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to enroll premenopausal patients, with early breast cancer who are non-low-risk and hormone receptor-positive and have undergone prior surgical intervention at the Breast Cancer Center of Sun Yat-sen Memorial Hospital, Sun Yat-sen University. These participants, receiving tamoxifen (TAM), toremifene (TOR), or aromatase inhibitors (AI) as adjuvant endocrine therapy and undergoing ovarian function suppression (OFS) treatment, will be divided into three groups, namely TOR+OFS, TAM+OFS, AI+OFS. The study will compare the efficacy and safety of TOR+OFS to that of TAM+OFS or AI+OFS in premenopausal estrogen receptor-positive breast cancer patients by comparing the 5-year disease-free survival (DFS) and quality of life etc. The objective is to evaluate whether TOR+OFS is non-inferior to TAM+OFS or AI+OFS in this specific patient population.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Patients at Intermediate to High Risk | — | UNRESOLVED | — |
| Hormone-receptor-positive Breast Cancer | — | UNRESOLVED | — |
| Ovarian Function Suppression Combined With Aromatase Inhibitor or Tamoxifen or Torimefen | — | UNRESOLVED | — |
| Premenopausal Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aromatase inhibitor | Drug | Aromatase Inhibitor | ALIAS |
| ovarian function suppression (Oophorectomy, Ovarian irradiation, Gonadotropin-releasing hormone agonist) | Procedure | — | UNRESOLVED |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
| toremifene | Drug | Toremifene | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- OFS+AI
- description
- patients undergoing ovarian function suppression (OFS) combined with aromatase inhibitor (AI)
- interventionNames
- Drug: Aromatase inhibitor
- Procedure: ovarian function suppression (Oophorectomy, Ovarian irradiation, Gonadotropin-releasing hormone agonist)
- label
- OFS+TAM
- description
- patients undergoing ovarian function suppression (OFS) combined with tamoxifen (TAM)
- interventionNames
- Procedure: ovarian function suppression (Oophorectomy, Ovarian irradiation, Gonadotropin-releasing hormone agonist)
- Drug: Tamoxifen
- label
- OFS+TOR
- description
- patients undergoing ovarian function suppression (OFS) combined with torimifene (TOR)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female, aged 18-60 2. Premenopausal patients with early hormone receptor-positive breast cancer at intermediate to high risk (Low risk is defined as having the following 6 items at the same time: lesion size (pT) in the specimen \<= 2cm; histological grade 1; no vessel carcinoma embolus; ER and/or PR positive; HER2 gene without overexpression or amplification; age \>=35 years old) 3. Completed radical surgery for breast cancer 4. Undergoing postoperative endocrine therapy (toremifene, tamoxifen, aromatase inhibitorI) at least five years at Sun Yat-sen Memorial Hospital of Sun Yat-sen University since 2010 5. Undergoing ovarian function suppression (Oophorectomy, Ovarian irradiation, Gonadotropin-releasing hormone agonist) Exclusion Criteria: 1. Imaging or pathology suggestive of metastatic breast cancer (chest wall, lung, bone, liver, brain) 2. Patients with a second primary tumor 3. Hepatic insufficiency at baseline 4. Known history of psychotropic substance abuse or drug abuse;
References
Publications (0)
Data not yet available