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New treatment option for Breast Cancer Female
Official title Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
ClinicalTrials.gov ID: NCT07242118
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health...
- 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
You likely can't join if
- Active treatment with systemic chemotherapy for breast cancer. people will need to stop any breast cancer chemotherapy agent before enrollment to be...
- Multicentric tumor.
- Clinical or imaging evidence of distant metastases.
- Prior ipsilateral breast or thoracic radiation.
- Autoimmune conditions with associated radiation risks.
See the full eligibility 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 how well it works assessment of the investigational regimen are eligible...
- Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial
- Active treatment with systemic chemotherapy for breast cancer. people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Kansas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Kansas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.