Back to search results

Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation for Breast Cancer

This study is looking at a new way to give radiation therapy after repeat breast conserving surgery for breast cancer that has returned. Currently, radiation is given twice a day for 30 treatments. This study will test if giving radiation once a day for 15 treatments (each lasting 30 minutes, 5 days a week for 3 weeks) works just as well. You may be able to join if you are at least 19 years old, have certain types of breast cancer that has returned, and your tumor is less than 3 cm. The study aims to see if this new radiation schedule causes fewer side effects. The current recruitment status is unclear, and the study plans to enroll 55 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 55 participants, but the phase is not specified.
What's involved
Participants will receive radiation treatment to the breast once a day for 5 days a week, over 3 weeks. Each radiation session will last 30 minutes.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-related side effects for 1 year after completing the radiation treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06129747

Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast

Recruiting
PHASE2Ages 19+InterventionalTreatment
Case Comprehensive Cancer Center
~55 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Radiation Therapy

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment-related adverse events as graded by CTCAE criteria
Measured over 1 year from the completion of re-irradiation

Conditions

Breast Cancer
Tumor, Breast

Explore related trials

Breast Carcinoma

Where it's being run

2 sites across 1 states
Ohio2

Study leadership

  • Janice Lyons, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
  • Rahul Tendulkar, MD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Who to contact

Janice Lyons, MD
[email protected]
(216) 844-2514
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Treatment-related adverse events as graded by CTCAE criteria1 year from the completion of re-irradiation

    Rate of grade 3+ treatment-related skin, fibrosis, and breast pain adverse events occurring within 1 year from the completion of re-irradiation as graded by CTCAE criteria.