Status:
RECRUITING
Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Breast Cancer
Tumor, Breast
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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 purpo...
Detailed Description
Breast cancer survival rates have greatly improved with advances in both screening and treatment. The standard of care for both early stage and selected locally advanced breast cancers is breast conse...
Eligibility Criteria
Inclusion
- Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), tubular or mixed histologies.
- 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). Patients 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 a no tumor on ink or a negative re-excision.
- Hormonal therapy is allowed. If chemotherapy is planned, it can be delivered either prior 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
- 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.
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 9 2029
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06129747
Start Date
November 30 2023
End Date
August 9 2029
Last Update
December 24 2025
Active Locations (2)
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1
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
2
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195