Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT07242118
Status
Recruiting
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Conditions

  • Breast Cancer Female

Eligibility Criteria

Sex
FEMALE
Age
65 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • SABR — RADIATION
    Radiation therapy will consist of either IMRT or 3D CRT. The modality chosen will be based on the plan with the preferable dosimetric variables and determined by the treating radiation oncology physician. SABR will be prescribed to a total dose of 35 Gy to the GTV over the course of 5 fractions (7 Gy per fraction), ideally treated every other day (excluding weekends). The CTV will be prescribed 30 Gy over 5 fractions, ideally treated every other day.

Study Details

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.

Key Dates

Start date
Nov 4, 2025
Status verified
Feb 2026
Primary completion
Sep 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SABR Intervention Without Surgery (Single Arm Only)
    Radiotherapy will be conducted in 5 fractions, every other day. The radiation dose used in this study will use a standard of care post-operative dose of 600 cGy per fraction at 5 total fractions delivered to the clinical target volume. However, since patients in this study will have gross disease and will not have received surgery, a higher dose will be given to the primary tumor itself. Study participants may not receive chemotherapeutic agents after enrollment, unless indicated for disease progression. Patients will be allowed to receive CKD 4/6 inhibitors. Patients will be allowed on this study whether they do or do not receive anti-hormonal therapy. If a patient has not started endocrine therapy before SABR, ideally, they would initiate endocrine therapy after undergoing SABR. If a patient has already started endocrine therapy before SABR, they may continue during the time of SABR at the discretion of the treating physician, as this is considered safe in this setting.

Primary Outcome Measure

1-month post-SABR Physical Well-Being [ Time Frame: 1 month ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160-
University of Kansas Medical CenterKansas CityKansas66160
Rachel Clinical Research Coordinator
[email protected]
913-588-6249

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By research site
University of Kansas Medical Center· Kansas City, KS

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