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 | Unknown

• 1 other identifier: SYSKY-2022-445-02
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• disease free survival

  The time from the beginning of treatment to the recurrence of the disease or death from any cause or the end of the visit

  5 years

• The score of life quality questionnaire assessed by SPF 36

  The score of SPF 36

  1 month

• The score of life quality questionnaire assessed by EQ-5D-5L

  The score of EQ-5D-5L

  1 month

Secondary Outcomes (1)

• The incidence of adverse events

  5 years

Study Arms (3)

OFS+AI

patients undergoing ovarian function suppression (OFS) combined with aromatase inhibitor (AI)

Drug: Aromatase inhibitor; Procedure: ovarian function suppression (Oophorectomy, Ovarian irradiation, Gonadotropin-releasing hormone agonist)

OFS+TAM

patients undergoing ovarian function suppression (OFS) combined with tamoxifen (TAM)

Procedure: ovarian function suppression (Oophorectomy, Ovarian irradiation, Gonadotropin-releasing hormone agonist); Drug: Tamoxifen

OFS+TOR

patients undergoing ovarian function suppression (OFS) combined with torimifene (TOR)

Procedure: ovarian function suppression (Oophorectomy, Ovarian irradiation, Gonadotropin-releasing hormone agonist); Drug: toremifene

Interventions

Aromatase inhibitor DRUG

Aromatase inhibitor includes Arimidex, Aromasin, Femara.

OFS+AI

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

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

OFS+AI; OFS+TAM; OFS+TOR

Tamoxifen DRUG

tamoxifen,10mg, bid

OFS+TAM

toremifene DRUG

toremifene, 60 mg, qd

OFS+TOR

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

1. Female, age ≥ 18 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)

You may qualify if:

• Female, aged 18-60
• 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)
• Completed radical surgery for breast cancer
• 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
• Undergoing ovarian function suppression (Oophorectomy, Ovarian irradiation, Gonadotropin-releasing hormone agonist)

You may not qualify if:

• Imaging or pathology suggestive of metastatic breast cancer (chest wall, lung, bone, liver, brain)
• Patients with a second primary tumor
• Hepatic insufficiency at baseline
• Known history of psychotropic substance abuse or drug abuse;

Sponsors & Collaborators

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

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Interventions

Aromatase Inhibitors; Ovariectomy; Gonadotropin-Releasing Hormone; Tamoxifen; Toremifene

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Chang Gong, docto

  Sun Yat-sen Memorial Hospital of Sun Yat-sen Univeristy

  STUDY CHAIR

Central Study Contacts

Chang Gong, doctor

CONTACT

13925089353; gchang@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 6, 2023
• Study Start: June 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Locations

CN (1)