Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04753177
Status:
UNKNOWN
Last Update Posted:
2021-02-15
First Post:
2021-02-06
Brief Title:
The Neoadjuvant Combined Hormone Therapy in Premenopausal Women With Locally Advanced ERHER2- Breast Cancer
Sponsor:
Saint Petersburg State Budgetary Healthcare Institution City Clinical Oncology Dispensary
Organization:
Saint Petersburg State Budgetary Healthcare Institution City Clinical Oncology Dispensary
Study Overview
Official Title:
The Neoadjuvant Combined Hormone Therapy in Premenopausal Women With Locally Advanced ERHER2- Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2021-02
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:
Breast cancer take a leading position in the structure of morbidity and mortality from malignant tumors among women
Today the interest of many scientists and pharmaceutical companies is focused on the study of metastatic breast cancer forms While we obtain little experimental data and practical research about the treatment of locally advanced forms
In this regard the study of new neoadjuvant drug therapy regimen for estrogen-receptor positive breast cancer in premenopausal woman is very relevant
The proposed research will be the absolutely innovative investigation worldwide
The study will consist of two modes of treatment combined hormone therapy with CDK46-ingibitors and chemotherapy the control each replicated four times in a randomized complete block design
This research aims to improve the results of treatment namely to increase the percentage of successfully treated patients and reduce toxicity from treatment
Primary study endpoints will include the frequency of objective response and complete pathomorphological response according to the Miller-Payne classification
Secondary endpoints will include a decrease of the Ki67 level in postoperative material compared to primary biopsy the frequency of organ-preserving operation after neoadjuvant treatment and quality of life
Study hypothesis neoadjuvant combined hormone therapy with CDK46-ingibitors in premenopausal women with luminal breast cancer leads to at least the same results as neoadjuvant chemotherapy but with less toxicity
Today the interest of many scientists and pharmaceutical companies is focused on the study of metastatic breast cancer forms While we obtain little experimental data and practical research about the treatment of locally advanced forms
In this regard the study of new neoadjuvant drug therapy regimen for estrogen-receptor positive breast cancer in premenopausal woman is very relevant
The proposed research will be the absolutely innovative investigation worldwide
The study will consist of two modes of treatment combined hormone therapy with CDK46-ingibitors and chemotherapy the control each replicated four times in a randomized complete block design
This research aims to improve the results of treatment namely to increase the percentage of successfully treated patients and reduce toxicity from treatment
Primary study endpoints will include the frequency of objective response and complete pathomorphological response according to the Miller-Payne classification
Secondary endpoints will include a decrease of the Ki67 level in postoperative material compared to primary biopsy the frequency of organ-preserving operation after neoadjuvant treatment and quality of life
Study hypothesis neoadjuvant combined hormone therapy with CDK46-ingibitors in premenopausal women with luminal breast cancer leads to at least the same results as neoadjuvant chemotherapy but with less toxicity
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None