Preoperative Irradiation for Stage I Breast Cancer (NCT05464667) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Preoperative Irradiation for Stage I Breast Cancer
United States15 participantsStarted 2023-07-07
Plain-language summary
The novel use of preoperative RT will have broad implications for breast cancer patients, most of whom present with early-stage disease. In the era of reduced chemotherapy delivery, preoperative RT will allow oncologists to assess radiologic and biologic tumor response and correlate it to outcomes. Underutilization of RT negatively affects mortality. This trial aims to further evaluate pre-operative radiation therapy in patients with early stage, biologically favorable breast cancer, with improved access to RT.
Who can participate
Age range50 Years
SexFEMALE
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Inclusion criteria
✓. Pathologically confirmed diagnosis of breast cancer within 90 days from breast biopsy. NOTE: The day of biopsy is Day "0"
✓. Patient biologically of the female sex
✓. Must meet ALL the following criteria:
✓.1. Age ≥ 50 years
✓.2. Clinical size ≤ 3 cm (invasive) or ≤ 4 cm (DCIS) based on results of dedicated breast imaging.
✓.3. All invasive subtypes and DCIS
✓.4. ER positive, HER2/neu negative
✓.5. No LVSI
Exclusion criteria
✕. Clinically staged breast cancer that does not meet all of the criteria delineated in Inclusion criteria 3.
✕. Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry
✕. Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix, melanoma in situ) unless disease free for a minimum of 5 years prior to study entry
✕. Non-epithelial breast malignancies such as sarcoma or lymphoma.
✕. Two or more documented breast cancers within the index breast or bilateral breast cancer.
✕. Suspicious unresected microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.