An observational study in Hormone-receptor-positive Breast Cancer, Premenopausal Breast Cancer and Breast Cancer Patients at Intermediate to High Risk, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-05-18.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational
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.
Selective estrogen receptor modulators (SERM), tamoxifen (TAM) and toremifene (TOR), have been proven to be effective in premenopausal estrogen receptor positive breast cancer patients with similar outcomes. In addition, many large-scale long-term follow-up clinical tials, such as ABCSG XII, SOFT, TEXT, ASTRRA, and ZIPP, have confirmed that premenopausal patients with hormone-receptor-positive breast cancer at intermediate to high risk could benefit from ovarian function suppression (OFS) combined with aromatase inhibitor (AI) or TAM. The Asian Breast Cancer Cooperative Group (ABCCG) also recommends OFS+TAM or OFS+AI for the treatment in this specific patient population. Notably, the therapeutic efficacy and safety profile of OFS in conjunction with TOR have yet to be investigated, nor has its comparative effectiveness with OFS plus TAM or OFS plus AI been established.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 700 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.
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Exclusion Criteria:
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)
patients undergoing ovarian function suppression (OFS) combined with tamoxifen (TAM)
Procedure: ovarian function suppression (Oophorectomy, Ovarian irradiation, Gonadotropin-releasing hormone agonist) · Drug: Tamoxifen
patients undergoing ovarian function suppression (OFS) combined with torimifene (TOR)
Procedure: ovarian function suppression (Oophorectomy, Ovarian irradiation, Gonadotropin-releasing hormone agonist) · Drug: toremifene
Aromatase inhibitor includes Arimidex, Aromasin, Femara.
Gonadotropin-releasing hormone agonist includes Buserelin, Goserelin, Leuprorelin, Nafarelin, Triptorelin
tamoxifen,10mg, bid
toremifene, 60 mg, qd
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
Time frame: 5 years
The score of life quality questionnaire assessed by SPF 36
The score of SPF 36
Time frame: 1 month
The score of life quality questionnaire assessed by EQ-5D-5L
The score of EQ-5D-5L
Time frame: 1 month
The incidence of adverse events
Incidence of adverse outcome events (such as musculoskeletal symptoms，osteoporosis, fragile, bone mineral density loss, hepatic insufficiency, dyslipidemia, endometrial hyperplasia, uterine fibroids, ovarian cyst, adenomyosis, hot flashes, night sweats etc.)
Time frame: 5 years
This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University