NCT06129747 Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast
| NCT ID | NCT06129747 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Case Comprehensive Cancer Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2023-11-30 |
| Primary Completion | 2029-08-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 55 participants in total. It began in 2023-11-30 with a primary completion date of 2029-08-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The standard treatment for participants whose cancer has returned after breast conserving surgery is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. The purpose of this study is to find out if giving radiation once a day for 15 treatments after repeat breast conserving surgery works as well as giving it the standard way.
Eligibility 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.
Contact & Investigator
Janice Lyons, MD
PRINCIPAL INVESTIGATOR
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06129747 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06129747 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06129747 currently recruiting?
Yes, NCT06129747 is actively recruiting participants. Contact the research team at Janice.lyons@uhhospitals.org for enrollment information.
Where is the NCT06129747 trial being conducted?
This trial is being conducted at Cleveland, United States, Cleveland, United States.
Who is sponsoring the NCT06129747 clinical trial?
NCT06129747 is sponsored by Case Comprehensive Cancer Center. The principal investigator is Janice Lyons, MD at University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center. The trial plans to enroll 55 participants.
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