Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05801705
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-18
First Post:
2023-03-26
Brief 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
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 TOROFS TAMOFS AIOFS The study will compare the efficacy and safety of TOROFS to that of TAMOFS or AIOFS 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 TOROFS is non-inferior to TAMOFS or AIOFS 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 OFSTAM or OFSAI 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 TOROFS TAMOFS AIOFS The study will compare the efficacy and safety of TOROFS to that of TAMOFS or AIOFS 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 TOROFS is non-inferior to TAMOFS or AIOFS in this specific patient population
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 TOROFS TAMOFS AIOFS The study will compare the efficacy and safety of TOROFS to that of TAMOFS or AIOFS 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 TOROFS is non-inferior to TAMOFS or AIOFS in this specific patient population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None