Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596018
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Assessing Combined SBRT in Breast Cancer Non-Responders to Neoadjuvant Chemotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety Evaluation of Combined Preoperative Radiotherapy in Breast Cancer Patients With No Response to Initial Neoadjuvant Chemotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to assess whether the addition of preoperative stereotactic body radiation therapy SBRT can improve pathological complete response pCR rates and safety in breast cancer patients who do not respond to initial neoadjuvant chemotherapy The main questions it aims to answer are
Can the combination of SBRT with chemotherapy increase pCR rates in non-responders to initial neoadjuvant chemotherapy
Does the addition of SBRT to chemotherapy have acceptable safety and tolerability profiles
Participants in this trial will be early or locally advanced breast cancer patients who have shown no response to two cycles of standard neoadjuvant chemotherapy They will be randomly assigned to either continue with the standard chemotherapy control group or receive SBRT in addition to continuing the standard chemotherapy intervention group The primary outcome measures will be pCR rate and breast conservation rate Secondary outcomes will include 3-year local progression-free survival overall survival surgical complications and treatment toxicities
Can the combination of SBRT with chemotherapy increase pCR rates in non-responders to initial neoadjuvant chemotherapy
Does the addition of SBRT to chemotherapy have acceptable safety and tolerability profiles
Participants in this trial will be early or locally advanced breast cancer patients who have shown no response to two cycles of standard neoadjuvant chemotherapy They will be randomly assigned to either continue with the standard chemotherapy control group or receive SBRT in addition to continuing the standard chemotherapy intervention group The primary outcome measures will be pCR rate and breast conservation rate Secondary outcomes will include 3-year local progression-free survival overall survival surgical complications and treatment toxicities
Detailed Description:
Neoadjuvant chemotherapy is a crucial component in the comprehensive treatment of breast cancer patients particularly for those with large initial tumors axillary lymph node metastasis HER-2 positive or triple-negative disease However some patients do not achieve the desired pathological complete response pCR after neoadjuvant chemotherapy The CTNeoBC meta-analysis has shown that breast cancer patients who achieve pCR after neoadjuvant therapy have a better prognosis compared to those who do not Specifically patients who reach pCR exhibit a recurrence rate of less than 10 whereas those who fail to achieve pCR may have a recurrence rate as high as 50 On the other hand in breast-conserving therapy patients typically undergo boost radiotherapy targeted at the tumor bed which is administered after the completion of whole-breast radiotherapy Existing evidence suggests that advancing the radiotherapy boost to the preoperative period is equally effective and safe To enhance the treatment outcomes for patients who do not respond to initial standard chemotherapy the investigators have designed this prospective preliminary study to assess the efficacy and safety of stereotactic body radiation therapy SBRT when added to neoadjuvant therapy in this population of chemotherapy non-responders
This study is a prospective randomized controlled trial Patients first undergo standard neoadjuvant chemotherapy with tumor size evaluated through physical examination or ultrasound after each cycle and breast MRI for tumor assessment after two cycles Patients who are assessed as having stable disease SD or progressive disease PD according to RECIST criteria are considered non-responders to initial neoadjuvant chemotherapy Participants will be randomly allocated in a 11 ratio to either the control group or the intervention group The control group will continue to follow the original chemotherapy regimen while the intervention group will receive SBRT treatment The specific plan for SBRT is to target the primary tumor region with a single dose of 8Gy using 6MV-X rays administered once a day for three consecutive days After the completion of SBRT patients will continue the remaining courses of neoadjuvant chemotherapy Both groups of patients will subsequently undergo standard surgery based on efficacy assessment followed by whole-breast hypofractionated radiotherapy 4-6 weeks postoperatively with a plan of 40-425Gy15-16 fractions without a boost to the original tumor area
This study is a prospective randomized controlled trial Patients first undergo standard neoadjuvant chemotherapy with tumor size evaluated through physical examination or ultrasound after each cycle and breast MRI for tumor assessment after two cycles Patients who are assessed as having stable disease SD or progressive disease PD according to RECIST criteria are considered non-responders to initial neoadjuvant chemotherapy Participants will be randomly allocated in a 11 ratio to either the control group or the intervention group The control group will continue to follow the original chemotherapy regimen while the intervention group will receive SBRT treatment The specific plan for SBRT is to target the primary tumor region with a single dose of 8Gy using 6MV-X rays administered once a day for three consecutive days After the completion of SBRT patients will continue the remaining courses of neoadjuvant chemotherapy Both groups of patients will subsequently undergo standard surgery based on efficacy assessment followed by whole-breast hypofractionated radiotherapy 4-6 weeks postoperatively with a plan of 40-425Gy15-16 fractions without a boost to the original tumor area
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None