Daily Partial Breast Irradiation After Repeat Breast Conserving Surgery for Breast Cancer
Official title: Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation for Participants With Ipsilateral Breast Tumor Recurrence Treated Initially With Breast Conserving Surgery and Whole Breast Radiation Therapy
Run by Case Comprehensive Cancer Center · NCT06129747 · Data updated 2026-11-12
This study tests if giving radiation once a day for 15 days after repeat breast surgery can work just as well as the usual twice-a-day treatment for patients with recurring breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 55 (estimated) |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Status | Recruiting |
| Started | November 30, 2023 |
| Main results expected | August 9, 2029 |
| Study ends | August 9, 2029 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT06129747 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women over 18 with histologically confirmed breast cancer recurrences that are less than 3 cm and have negative resection margins.
✕Probably not a fit
Patients with larger tumors or those who have not had successful prior breast conserving surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of daily partial breast irradiation following repeat breast conserving surgery in patients with recurrent breast cancer. Traditionally, patients receive radiation twice daily for 30 treatments, which can be burdensome. The study aims to determine if a regimen of once-daily radiation for 15 treatments can provide similar local control while being more convenient for patients. Participants will be closely monitored for treatment tolerance and outcomes.
Why it matters
Potential benefit: If successful, this approach could offer a less burdensome and more patient-friendly option for managing breast cancer recurrences.
How similar studies have gone: Other studies have shown promise with similar approaches, but this specific regimen is being evaluated for the first time.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), tubular or mixed histologies. Three years of time must have elapsed since the end of the last course of whole breast irradiation. * Lesion size \< 3 cm treated with a partial mastectomy. Participants with invasive cancer and clinically and radiographically negative axillas do not require an axillary lymph node sampling unless they did not have prior axillary lymph node sampling (e.g. previous cancer was DCIS). Participants with DCIS as their recurrence do not require surgical assessment of the axilla. Repeat sentinel lymph node biopsy is permitted. * Negative resection margins with at least no tumor on ink or a negative re-excision. * Participants with invasive recurrence must have a negative re-staging work-up consisting of either a CT chest/abdomen and a bone scan or a PET scan. * Hormonal therapy is allowed. If chemotherapy is planned, it can be delivered either prior to or after the radiation is delivered. There must be at least 2 weeks between radiation and chemotherapy. HER2 directed therapy can be delivered concurrently with radiation. * Participants must be \> 18 years of age. Because no dosing or adverse event data are currently available on the use of breast re-irradiation in participants ≤18 years of age, children are excluded from this study. * Participants must have the ability to understand and the willingness to sign a written informed consent document. * Performance status: ECOG Performance status ≤ 2. * Life expectancy of ≥ 12months, in the opinion of and as documented by the investigator. * Not based on gender; this trial is open to any gender, defined as self-representation of gender identity. Exclusion Criteria: * Participants with nodal or distant metastatic disease \< 3 years since prior radiation. * Participants with invasive pure lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or uncontrolled nonepithelial breast malignancies such as lymphoma or sarcoma. * Participants with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative. * Participants with Paget's disease of the nipple. * Participants with skin involvement. * Participants with scleroderma or dermatomyositis. * Participants with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent. * Participants who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females. * Participants with known BRCA 1/BRCA 2 mutations.
Where it's running
-
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States Recruiting -
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Janice Lyons, MD — University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
- Study coordinator: Janice Lyons, MD
- Email: Janice.lyons@uhhospitals.org
- Phone: (216) 844-2514
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.