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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment55 people
  • Recruiting US sites2
  • SponsorCase Comprehensive Cancer Center
  • RegistryNCT06129747

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast: a one-minute explainerNCT061297471 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age19 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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.

You cannot join if

  • 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.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • Radiation Therapy (Radiation): Weeks 1, 2 and 3 * Weeks 1, 2 and 3 will include 5 days of treatment. * One radiation treatment to breast on each of the 5 days. Each radiation treatment session will last a 30 minutes.

The study

Treatment groups

Na · Single Group · masking: None

Radiation Therapy(RT) (Experimental)

There will be one treatment cohort. Radiation therapy will be delivered daily for 15 daily fractions, 2.67Gy per fraction, delivered using a 3-D or IMRT(Intensity Modulate Radiation Therapy) plan. For participants with high-risk features deemed by the radiation oncologist who would otherwise be a candidate for a boost (age <50, high grade, poor biology, close margins), 48 Gy delivered in fifteen fractions of 3.2 Gy is allowed.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • surgery: Part of the study plan
  • radiation: Part of the study plan

Goals

What the study measures

Main goals

  • Treatment-related adverse events as graded by CTCAE criteria (1 year from the completion of re-irradiation)

Other goals

  • In-breast tumor recurrence rate
  • In-breast tumor recurrence rate
  • In-breast tumor recurrence rate
  • Rate of freedom from mastectomy
  • Rate of freedom from mastectomy
  • Rate of freedom from mastectomy
  • Treatment-related adverse events
  • Treatment-related adverse events
  • Evaluation of Cosmesis
  • Evaluation of Cosmesis
  • Overall survival rate
  • Overall survival rate
  • Overall survival rate
  • Mastectomy-free survival rate
  • Mastectomy-free survival rate
  • Mastectomy-free survival rate

Planned enrollment: 55 (estimated).

Where

Recruiting US sites

  • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio
  • Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 5, 2026. Public record; not medical advice.

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