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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 · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2023-05-18

No results posted yet for this study

Summary

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

  • Hormone-receptor-positive Breast Cancer
  • Premenopausal Breast Cancer
  • Breast Cancer Patients at Intermediate to High Risk
  • Ovarian Function Suppression Combined With Aromatase Inhibitor or Tamoxifen or Torimefen

Interventions

DRUG

Aromatase inhibitor

Aromatase inhibitor includes Arimidex, Aromasin, Femara.

PROCEDURE

ovarian function suppression (Oophorectomy, Ovarian irradiation, Gonadotropin-releasing hormone agonist)

Gonadotropin-releasing hormone agonist includes Buserelin, Goserelin, Leuprorelin, Nafarelin, Triptorelin

DRUG

Tamoxifen

tamoxifen,10mg, bid

DRUG

toremifene

toremifene, 60 mg, qd

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Chang Gong, docto · Sun Yat-sen Memorial Hospital of Sun Yat-sen Univeristy

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-06-30
Completion
2023-12-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05801705 on ClinicalTrials.gov