Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04666805
Status:
UNKNOWN
Last Update Posted:
2020-12-14
First Post:
2020-12-04
Brief Title:
Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With HR Intraductal Carcinoma of the Breast
Sponsor:
First Hospital of China Medical University
Organization:
First Hospital of China Medical University
Study Overview
Official Title:
Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With Hormone Receptor-positive Intraductal Carcinoma of the Breast A Multicenter Retrospective Real-world Study
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 will investigate the relationship between the endocrine therapy and the survival of patients with hormone receptor positive intraductal carcinoma of the breast and the optimal duration of medication This study will also analyze the risk factors of recurrence and metastasis of hormone receptor positive intraductal carcinoma of the breast and establish a prognosis model to further clarify the specific reasons for recurrence and metastasis adverse reactions and drug withdrawal in patients with hormone receptor positive intraductal carcinoma of the breast after endocrine therapy
Detailed Description:
Intraductal carcinoma of the breast accounts for 20 of newly diagnosed breast cancer In addition to necessary surgical treatment 5-year endocrine therapy is also essential for patients with hormone receptor positive ductal carcinoma of the breast Commonly used drugs include selective estrogen receptor modulators Tamoxifen Toremifene and aromatase inhibitors Exemestane Anastrozole Letrozole Although these drugs can effectively reduce the recurrence and metastasis of ductal carcinoma of the breast the adverse reactions of the above drugs significantly reduce the quality of life and treatment compliance of the patients Therefore the choice of endocrine therapy for intraductal carcinoma of the breast has been widely discussed Is it possible for de-escalation of endocrine treatment intensity to reduce adverse reactions and improve patient compliance Recently a phase 3 clinical trial found that compared with placebo group the adverse reactions of Tamoxifen group treated with 5 mgd conventional dose 20 mgd Tamoxifen for 3 years had less adverse reactions and achieved significant efficacy This study revealed the reliable efficacy and safety of Tamoxifen a low-dose drug for treatment of hormone receptor positive intraductal carcinoma of the breast However little is reported on the reasonable duration of Aromatase inhibitors for endocrine therapy in patients with intraductal carcinoma of the breast
This study will investigate the relationship between the endocrine therapy and the survival of patients with hormone receptor positive intraductal carcinoma of the breast and the optimal duration of medication This study will also analyze the risk factors of recurrence and metastasis of hormone receptor positive intraductal carcinoma of the breast and establish a prognosis model to further clarify the specific reasons for recurrence and metastasis adverse reactions and drug withdrawal in patients with hormone receptor positive intraductal carcinoma of the breast after endocrine therapy
This study will investigate the relationship between the endocrine therapy and the survival of patients with hormone receptor positive intraductal carcinoma of the breast and the optimal duration of medication This study will also analyze the risk factors of recurrence and metastasis of hormone receptor positive intraductal carcinoma of the breast and establish a prognosis model to further clarify the specific reasons for recurrence and metastasis adverse reactions and drug withdrawal in patients with hormone receptor positive intraductal carcinoma of the breast after endocrine therapy
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