Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640881
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Preoperative Partial Breast Reirradiation and Repeat Breast-conserving Surgery in Patients with Recurrent Breast Cancer the REPEAT Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Preoperative Partial Breast Reirradiation and Repeat Breast-conserving Surgery in Patients with Recurrent Breast Cancer the REPEAT Trial - a Study Protocol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
REPEAT
Brief Summary:
Over the past decades interest in second breast-conserving therapy BCT has increased due to among others advancements in radiotherapy techniques Preoperative partial breast irradiation PBI is an experimental treatment for patients with low-risk primary breast cancer This approach can downstage the tumor and may possibly reduce toxicity and improve cosmetic outcomes compared to postoperative radiotherapy This study aims to evaluate the feasibility of single-dose preoperative PBI and second breast-conserving surgery BCS for patients with an ipsilateral recurrent breast event IRBE after previous BCT
The REPEAT trial is a multicenter prospective single-arm trial investigating ablative single-dose preoperative PBI in patients with an IRBE Eligible patients are 50 years have a unifocal non-lobular invasive breast cancer 2 cm Bloom-Richardson grade 1 or 2 estrogen receptor-positive HER2-negative and clinically negative axillary lymph nodes The study plans to enroll 25 patients Radiotherapy planning will involve the use of CT and MRI in the treatment position Single-dose PBI of 20 Gy to the tumor and 15 Gy to the surrounding 2 cm of breast tissue will be delivered using a conventional or MR-guided linear accelerator Tumor response will be monitored preoperatively using MRI and liquid biopsies to identify biomarkers for evaluating radiosensitivity BCS will be performed 3 weeks post-PBI The primary endpoint is the incidence of grade 2 or higher treatment-associated acute toxicity within 90 days Secondary endpoints include the evaluation of acute grade 1 and late toxicity radiologic and pathologic response mastectomy rate patient-reported outcomes cosmetic outcome local regional and distant recurrence rates survival outcome and biomarkers in liquid biopsies and tumor tissue Patients will be followed up to 5 years after PBI
This trial will evaluate the feasibility of single-dose preoperative PBI and BCS for patients with IRBE This treatment approach is expected to minimize the irradiated volume reduce toxicity and improve cosmetic outcomes compared to postoperative PBI after second BCS Identifying biomarkers for radiosensitivity will help in selection patients and tailoring treatment
The REPEAT trial is a multicenter prospective single-arm trial investigating ablative single-dose preoperative PBI in patients with an IRBE Eligible patients are 50 years have a unifocal non-lobular invasive breast cancer 2 cm Bloom-Richardson grade 1 or 2 estrogen receptor-positive HER2-negative and clinically negative axillary lymph nodes The study plans to enroll 25 patients Radiotherapy planning will involve the use of CT and MRI in the treatment position Single-dose PBI of 20 Gy to the tumor and 15 Gy to the surrounding 2 cm of breast tissue will be delivered using a conventional or MR-guided linear accelerator Tumor response will be monitored preoperatively using MRI and liquid biopsies to identify biomarkers for evaluating radiosensitivity BCS will be performed 3 weeks post-PBI The primary endpoint is the incidence of grade 2 or higher treatment-associated acute toxicity within 90 days Secondary endpoints include the evaluation of acute grade 1 and late toxicity radiologic and pathologic response mastectomy rate patient-reported outcomes cosmetic outcome local regional and distant recurrence rates survival outcome and biomarkers in liquid biopsies and tumor tissue Patients will be followed up to 5 years after PBI
This trial will evaluate the feasibility of single-dose preoperative PBI and BCS for patients with IRBE This treatment approach is expected to minimize the irradiated volume reduce toxicity and improve cosmetic outcomes compared to postoperative PBI after second BCS Identifying biomarkers for radiosensitivity will help in selection patients and tailoring treatment
Detailed Description:
None
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