Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-01-16 @ 1:33 AM
Study NCT ID:
NCT07242118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
Sponsor:
University of Kansas Medical Center
Organization:
Study Overview
Official Title:
Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
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:
CARMEN
Brief Summary:
This phase II study evaluates SABR as non-operative treatment for women aged 65+ with ER-positive, HER2-negative breast cancer ≤5 cm and no lymph node involvement. Eligible patients, including those previously on endocrine therapy, receive 5 SABR treatments, followed by monitoring of quality of life and assessment of treatment-related toxicity.
Detailed Description:
This is a prospective, phase II study of women with localized breast cancer receiving non-operative management with SABR delivered to the primary tumor. Patients will be screened that are age 65 and over with invasive breast cancer. Those eligible for the trial will have ER-positive and HER2-negative disease measuring ≤5 cm with negative clinical lymph nodes. Patients that were previously on primary ET, with either stable or progressive disease, will be eligible for this study if other inclusion criteria are met. Participants will receive SABR targeting the tumor consisting of 5 total treatments. Participants will then follow-up as per protocol with quality-of-life assessments and treatment-related toxicity evaluation.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: