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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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.

Study sites (2)

KS