Trial Title:
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
NCT ID:
NCT05801705
Condition:
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
Conditions: Official terms:
Breast Neoplasms
Vision Disorders
Tamoxifen
Toremifene
Hormones
Aromatase Inhibitors
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Drug
Intervention name:
Aromatase inhibitor
Description:
Aromatase inhibitor includes Arimidex, Aromasin, Femara.
Arm group label:
OFS+AI
Intervention type:
Procedure
Intervention name:
ovarian function suppression (Oophorectomy, Ovarian irradiation, Gonadotropin-releasing hormone agonist)
Description:
Gonadotropin-releasing hormone agonist includes Buserelin, Goserelin, Leuprorelin,
Nafarelin, Triptorelin
Arm group label:
OFS+AI
Arm group label:
OFS+TAM
Arm group label:
OFS+TOR
Intervention type:
Drug
Intervention name:
Tamoxifen
Description:
tamoxifen,10mg, bid
Arm group label:
OFS+TAM
Intervention type:
Drug
Intervention name:
toremifene
Description:
toremifene, 60 mg, qd
Arm group label:
OFS+TOR
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
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)
Sampling method:
Non-Probability Sample
Criteria:
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;
Gender:
Female
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Contact:
Last name:
Gong Chang, doctor
Phone:
02034070499
Email:
changgong282@163.com
Start date:
June 1, 2023
Completion date:
December 30, 2023
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05801705
