Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635980
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Hypofractionated Radiotherapy Before or After Breast Surgery for Treatment of Patients With Non-Metastatic Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Phase II Trial of Hypofractionated Radiotherapy for Non-Metastatic Breast Cancer Before or After Breast Surgery for Different Breast Cancer Risk Groups
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:
None
Brief Summary:
This phase II trial studies how well hypofractionated radiotherapy before preoperative or after postoperative breast surgery works in treating patients with different types of non-metastatic has not spread from original tumor site breast cancer and to determine the outcomes and side effects of this treatment Radiation therapy is considered an integral part of breast conserving therapy Hypofractionated radiation therapy is a radiation treatment in which the total dose of radiation is divided into large doses and treatments are given less than once a day This has been shown to be an effective treatment for breast cancer while reducing treatment time and decreasing side effects Preoperative radiotherapy alone or concurrently with chemotherapy has also been tested with excellent results and with minimal toxicity Preoperative radiation of the intact tumor with a hypofractionated regimen can potentially decrease toxicity by allowing the delivery of treatment to intact breast tissue The potential advantages of preoperative radiation therapy include the delivery of radiation in the intact breast when radiation can be more effective as more oxygen can be available in the tissue Furthermore complications and cosmetic results are expected to be lower in pre-operative radiotherapy before surgery as there have been no changes in blood supply to the breast This lends to the possibility of using lower doses of radiotherapy to patients and potentially better cancer associated clinical outcomes for our breast cancer patients Undergoing hypofractionated radiation therapy before or after breast surgery may be safe and effective in treating patients with different types of non-metastatic breast cancer
Detailed Description:
PRIMARY OBJECTIVE
I Compare grade G3 or higher radiation treatment related adverse events with the use of preoperative and postoperative radiation within the first 2-years
CORRELATIVE AND EXPLORATORY OBJECTIVES
I Grade 3 wound complications and seroma infection between preop and postoperative radiation
II Locoregional control with or without surgery at 2-years in group D Her2 III To evaluate radiographic complete response and near complete response IV To estimate the 5-year locoregional control distant recurrence invasive disease-free survival cause-specific survival and overall survival
V To evaluate patient-reported outcomes VI To evaluate clinical features treatment technique dose-volume parameters histologic and genetic variants associated with adverse events and fair and poor cosmetic outcomes or unplanned surgical intervention
VII Evaluate tumor mutation signatures before and after chemotherapy radiation and surgery correlate tumor mutation signatures before and after radiation with pathologic information at the time of surgery
VIII To describe the pathologic changes seen in breast cancer patients with preoperative radiation
IX Evaluate circulating tumor deoxyribonucleic acid DNA tumor infiltrating lymphocytes neo-epitopes and peripheral blood mononuclear before and after chemotherapy radiation and surgery correlate tumor mutation signatures before and after radiation with pathologic information at the time of surgery
X Group A-D Determine the rate of implanttissue expander failure after preop and postop radiation
XI Group A-C To determine the pathologic complete response pCR rate and near pathologic rate with cellularity 10 after neoadjuvant chemotherapy and hypofractionated radiotherapy to the whole breast with nodal irradiation if indicated based on the postsurgical specimen
XII Group D Determine locoregional control with the use of preoperative radiation conformal radiation It will be determined based on the number of patients with controlled locoregional disease at 6-months
XIII Group A-C To determine true radiographic complete response based on post treatment positron emission tomography PET standardized uptake value SUV 25 or uptake mediastinum
XIV Group A-C To determine the pathologic complete response pCR rate and near pathologic rate with cellularity 10 after neoadjuvant chemotherapy and hypofractionated radiotherapy to the whole breast with nodal irradiation if indicated based on the postsurgical specimen
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients undergo standard of care SOC chemotherapy followed by breast hypofractionated radiotherapy once daily QD for a total of 5 fractions Patients then undergo SOC breast surgery 10 weeks after radiation treatment Patients also undergo computed tomography CT magnetic resonance imaging MRI positron emission tomography PET contrast-enhanced digital mammography CEDM andor breast ultrasound US throughout the study Additionally patients undergo a biopsy and may undergo optional blood sample collection and tissue collection on study
ARM II Patients undergo SOC chemotherapy and SOC breast surgery followed by breast hypofractionated radiotherapy QD for a total of 5 fractions Patients also undergo CT MRI PET CEDM andor breast US throughout the study Additionally patients undergo a biopsy and may undergo optional blood sample collection and tissue collection on study
After completion of study treatment patients are followed up at 16 weeks 6 months 12 months 24 months 36 months and at 5 years
I Compare grade G3 or higher radiation treatment related adverse events with the use of preoperative and postoperative radiation within the first 2-years
CORRELATIVE AND EXPLORATORY OBJECTIVES
I Grade 3 wound complications and seroma infection between preop and postoperative radiation
II Locoregional control with or without surgery at 2-years in group D Her2 III To evaluate radiographic complete response and near complete response IV To estimate the 5-year locoregional control distant recurrence invasive disease-free survival cause-specific survival and overall survival
V To evaluate patient-reported outcomes VI To evaluate clinical features treatment technique dose-volume parameters histologic and genetic variants associated with adverse events and fair and poor cosmetic outcomes or unplanned surgical intervention
VII Evaluate tumor mutation signatures before and after chemotherapy radiation and surgery correlate tumor mutation signatures before and after radiation with pathologic information at the time of surgery
VIII To describe the pathologic changes seen in breast cancer patients with preoperative radiation
IX Evaluate circulating tumor deoxyribonucleic acid DNA tumor infiltrating lymphocytes neo-epitopes and peripheral blood mononuclear before and after chemotherapy radiation and surgery correlate tumor mutation signatures before and after radiation with pathologic information at the time of surgery
X Group A-D Determine the rate of implanttissue expander failure after preop and postop radiation
XI Group A-C To determine the pathologic complete response pCR rate and near pathologic rate with cellularity 10 after neoadjuvant chemotherapy and hypofractionated radiotherapy to the whole breast with nodal irradiation if indicated based on the postsurgical specimen
XII Group D Determine locoregional control with the use of preoperative radiation conformal radiation It will be determined based on the number of patients with controlled locoregional disease at 6-months
XIII Group A-C To determine true radiographic complete response based on post treatment positron emission tomography PET standardized uptake value SUV 25 or uptake mediastinum
XIV Group A-C To determine the pathologic complete response pCR rate and near pathologic rate with cellularity 10 after neoadjuvant chemotherapy and hypofractionated radiotherapy to the whole breast with nodal irradiation if indicated based on the postsurgical specimen
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients undergo standard of care SOC chemotherapy followed by breast hypofractionated radiotherapy once daily QD for a total of 5 fractions Patients then undergo SOC breast surgery 10 weeks after radiation treatment Patients also undergo computed tomography CT magnetic resonance imaging MRI positron emission tomography PET contrast-enhanced digital mammography CEDM andor breast ultrasound US throughout the study Additionally patients undergo a biopsy and may undergo optional blood sample collection and tissue collection on study
ARM II Patients undergo SOC chemotherapy and SOC breast surgery followed by breast hypofractionated radiotherapy QD for a total of 5 fractions Patients also undergo CT MRI PET CEDM andor breast US throughout the study Additionally patients undergo a biopsy and may undergo optional blood sample collection and tissue collection on study
After completion of study treatment patients are followed up at 16 weeks 6 months 12 months 24 months 36 months and at 5 years
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