IRB Study Number 24-133
Status Recruiting
Phase Phase 2
Institute Taussig Cancer Institute
Description
2.1 Primary Objective
To determine the rate of grade 3+ treatment-related skin, fibrosis, and breast pain adverse events that occurred within 1 year from the completion of reirradiation.
2.2 Secondary Objective(s)
2.2.1 To determine the overall in-breast tumor recurrence.
2.2.2 To determine the freedom from mastectomy rate
2.2.3 To determine the all treatment-related adverse events for the following time periods:
a. After 1 year from completion of re-irradiation
b. Overall
2.2.4. To determine cosmesis (evaluated at 1 and 3 years).
2.2.5. To determine overall survival (failure: death due to any cause).
2.2.6 To determine mastectomy-free survival (failure: mastectomy of the treated breast or death due to any cause).
Inclusion Criteria
4.1.1 Patients’ recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.
4.1.2 Lesion size < 3 cm treated with a partial mastectomy. Patients with 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). Repeat sentinel lymph node biopsy is permitted.
4.1.3 Unifocal breast cancer recurrence.
4.1.4 Negative resection margins with at least a no tumor on ink from invasive and 2 mm margins for ductal carcinoma in-situ or a negative re-excision.
4.1.5 Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of radiation.
4.1.6 Patients must be > 18 years of age. Because no dosing or adverse event data are currently available on the use of breast re-irradiation in subjects ≤18 years of age, children are excluded from this study.
4.1.7 Subjects must have the ability to understand and the willingness to sign a written informed consent document.
4.1.8 Performance status: ECOG Performance status ≤ 2.
4.1.9 Life expectancy of ≥ 12months, in the opinion of and as documented by the investigator.
4.1.10 Not based on gender; this trial is open to any gender, defined as self-representation of gender identity.
Exclusion Criteria
4.2.1 Patients with nodal or distant metastatic disease
4.2.2 Patients with invasive 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.
4.2.3 Patients 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.
4.2.4 Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is DCIS and DCIS present in adjacent breast tissue. Presence of an EIC increases the chance of local recurrence, and as such, one might not be a candidate for repeat breast conservation.
4.2.5 Patients with Paget’s disease of the nipple.
4.2.6 Patients with skin involvement.
4.2.7 Patients with systemic lupus erythematosus requiring pharmacologic management, scleroderma, or dermatomyositis.
4.2.8 Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.
4.2.9 Patients who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.
4.2.10 Patients with known BRCA 1/BRCA 2 mutations.
