Recruiting
Phase 2

Radiation

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT06129747

Conditions

Breast Cancer

Tumor, Breast

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Radiation Therapy

Study Details

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.

Conditions

Breast Cancer

Tumor, Breast

Study ID

NCT06129747

Start date

Nov 30, 2023

Status verified date

Aug, 2026

Completion date

Aug 9, 2029

Anticipated

Primary completion date

Aug 9, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Radiation Therapy(RT)

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.

Interventions

Radiation Therapy

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.

Primary outcome measure

  • Treatment-related adverse events as graded by CTCAE criteria [ Time Frame: 1 year from the completion of re-irradiation ]

Central Contacts and Locations

Central contacts

Janice Lyons, MD

(216) 844-2514Janice.lyons@uhhospitals.org

Locations

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106-5065

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Rahul Tendulkar, MD

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Rahul Tendulkar, MD

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Radiation Therapy
  • In-Breast Recurrence
  • Tumor
  • Re-irradiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-06.