Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299852
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-25
Brief Title:
Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer
Sponsor:
NN Petrov National Medical Research Center of Oncology
Organization:
NN Petrov National Medical Research Center of Oncology
Study Overview
Official Title:
Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-02
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 involves two non-randomized groups of patients the observation group and the comparison group The comparison group will retrospectively include data on 29 patients with oligometastatic HER2-positive breast cancer who received treatment with trastuzumab-emtansine and had a history of SRT
The prospective part of this study aims to include 29 patients with oligometastatic HER2-positive breast cancer These patients will undergo SRT followed by the administration of trastuzumab emtansine 24 hours after the SRT
The combined effect of stereotactic radiation therapy on a metastatic lesion followed by anti-HER2 therapy in the 2nd line - trastuzumab emtansine remains unexplored This study plans to evaluate the effectiveness of combining systemic therapy and local control methods SRT in patients with oligometastatic HER2-positive breast cancer It will be the first time the efficacy and toxic profile of this new combined treatment method in this patient population will be studied This basket trial evaluates trastuzumab emtansine for oligo-metastatic breast cancer with the aim of inducing deep responses long-lasting disease remissions and potentially cure
The prospective part of this study aims to include 29 patients with oligometastatic HER2-positive breast cancer These patients will undergo SRT followed by the administration of trastuzumab emtansine 24 hours after the SRT
The combined effect of stereotactic radiation therapy on a metastatic lesion followed by anti-HER2 therapy in the 2nd line - trastuzumab emtansine remains unexplored This study plans to evaluate the effectiveness of combining systemic therapy and local control methods SRT in patients with oligometastatic HER2-positive breast cancer It will be the first time the efficacy and toxic profile of this new combined treatment method in this patient population will be studied This basket trial evaluates trastuzumab emtansine for oligo-metastatic breast cancer with the aim of inducing deep responses long-lasting disease remissions and potentially cure
Detailed Description:
This study involves two non-randomized groups of patients the observation group and the comparison group
The comparison group will retrospectively include data on 29 patients with oligometastatic HER2-positive breast cancer who were treated with trastuzumab-emtansine and had a history of SRT The dynamics of the process will be evaluated retrospectively using CT and MRI data according to RECIST 11 criteria The main statistical indicators will be calculated based on the patients medical documentation
The prospective part of this study aims to include 29 patients with oligometastatic HER2-positive breast cancer These patients will undergo SRT for up to 2 cycles depending on the location of the irradiated focus followed by administration of trastuzumab emtansine 36 mcgkg once every 3 weeks up to 4 total cycles Trastuzumab emtansine therapy will be initiated 24 hours after the end of the course of SRT Tumor foci will be assessed according to RECIST 11 criteria
Objective response general condition and adverse events will be evaluated before during and after treatment
Patients will be stratified by age location of metastatic foci and treatment Outpatient patient records medical histories clinical and laboratory examination data morphological examination data CT findings MRI findings will be used as sources of information for analyzing the results of diagnosis and treatment
The comparison group will retrospectively include data on 29 patients with oligometastatic HER2-positive breast cancer who were treated with trastuzumab-emtansine and had a history of SRT The dynamics of the process will be evaluated retrospectively using CT and MRI data according to RECIST 11 criteria The main statistical indicators will be calculated based on the patients medical documentation
The prospective part of this study aims to include 29 patients with oligometastatic HER2-positive breast cancer These patients will undergo SRT for up to 2 cycles depending on the location of the irradiated focus followed by administration of trastuzumab emtansine 36 mcgkg once every 3 weeks up to 4 total cycles Trastuzumab emtansine therapy will be initiated 24 hours after the end of the course of SRT Tumor foci will be assessed according to RECIST 11 criteria
Objective response general condition and adverse events will be evaluated before during and after treatment
Patients will be stratified by age location of metastatic foci and treatment Outpatient patient records medical histories clinical and laboratory examination data morphological examination data CT findings MRI findings will be used as sources of information for analyzing the results of diagnosis and treatment
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