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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-04

Study Completion Date

2027-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Female

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Study of women with localized ER+ and HER2- breast cancer receiving non-operative management with SABR delivered to the primary tumor.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SABR

Intervention Type 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.

Interventions

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SABR

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.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Women greater than or equal to age 65 years
* Diagnosis of invasive carcinoma of breast undergoing non-operative management
* Previously untreated OR previously treated with primary ET or chemotherapy, with either stable or progressive localized disease.
* Tumor measuring ≤5 cm (cT1-T2) and clinically node negative
* Diagnostic biopsy ER-positive (greater than or equal to 10% ER by immunohistochemistry staining)
* Diagnostic biopsy HER2-negative according to ASCO/CAP guidelines (0 or 1+ following IHC staining or proven negative by in-situ hybridization)
* Suitable for SABR as deemed by the treating radiation oncologist
* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial

Exclusion Criteria

* Active treatment with systemic chemotherapy for breast cancer. Subjects will need to stop any breast cancer chemotherapy agent before enrollment to be included study.
* Multicentric tumor.
* Clinical or imaging evidence of distant metastases.
* Prior ipsilateral breast or thoracic radiation.
* Autoimmune conditions with associated radiation risks.

Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes