Partial Breast Re-irradiation in Women in Women With Locally Recurrent Breast Cancer Previously Treated With Conservative Surgery and Whole Breast Irradiation (PBReI)
Breast Cancer, Recurrent
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Partial re-irradiation, recurrent breast cancer, conservative surgery
Eligibility Criteria
Inclusion Criteria: Isolated ipsilateral unifocal breast lesions; Histologically confirmed invasive breast carcinoma or carcinoma in situ; Limited size (< 2 cm) without evidence of skin involvement; Negative histologic margins of resection; Negative axillary lymph nodes; No synchronous distant metastases; Bilateral breast mammogram or MRI within 120 days prior to study entry; For invasive in-breast recurrence, no more than 120 days since whole-body (positron emission tomography) Positron Emission Tomography -Computerized Tomography scan or Computerized Tomography scan of the chest, abdomen, and pelvis, and bone scan; ≥ 24 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence; 10. Female, aged >18 years; 11. Life expectancy of greater than 12 months; 12. Eastern Cooperative Oncology Group (ECOG) performance status <2; 13. Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 4 months thereafter; 14. Participant is willing and able to give informed consent for participation in the study; Exclusion Criteria: Regional recurrences (axillary, supraclavicular); Positive histologic margins at resection; Metastatic disease; Previous breast Radiotherapy performed with Intraoperative radiotherapy, brachytherapy or previous partial breast treatment; Known pathogenic mutation of BRCA1, BRCA2 or Tumor Protein 53 gene; Patients who had chemotherapy within 2 weeks prior to study Radiotherapy; Participation in another clinical trial with any investigational agents within 30 days prior to study screening; Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; Significant comorbidity precluding radiotherapy for breast cancer (cardiovascular or pulmonary disease, sclerodermia, systemic lupus erythematosus); 10. Other known malignant neoplastic diseases in the patient's medical history with a disease free interval of less than 5 years (except for previously treated basal cell carcinoma of the skin and in situ carcinoma of the uterine cervix, endometrium or colon); 11. Inaccessibility for follow-up
Sites / Locations
- UO Radioterapia, IRST IRCCSRecruiting
Arms of the Study
Arm 1
Experimental
Partial breast re-irradiation
partial breast re-irradiation in patients with local recurrence of breast cancer, previously treated with breast conservative surgery and whole breast radiotherapy. A total dose of 35 Gy in 10 daily fractions, 5 fractions per week, will be prescribed.