About this trial
A prospective study of partial breast re-irradiation in patients with local recurrence of breast cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Regional recurrences (axillary, supraclavicular);
Positive histologic margins at resection;
Metastatic disease;
Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment;
Trial design
Single group
Treatments tested in this trial
Partial breast re-irradiation
Radiationpartial breast re-irradiation
Treatment groups
Trial outcomes
Primary outcomes
Treatment related toxicity
determine the toxicity of partial breast re-irradiation (PBrI) as rate of grade ≥ 3 treatment-related skin, fibrosis, and breast pain Adverse Events, accordin to Common Terminology Criteria for Adverse Events scale 5.0 (Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE) up to 1 year from completion of radiation treatment
Secondary outcomes
in-breast recurrence in the ipsilateral breast
In-breast recurrence is defined histologic evidence of recurrent carcinoma, invasive or noninvasive (excluding lobular carcinoma in situ), in the ipsilateral breast
Number of patients free from mastectomy over total number of patients
Freedom from mastectomy is calculated from mastectomy failure rates. Failure is a mastectomy of the treated breast performed for any reason
To evaluate distant-metastasis free survival
Distant metastasis-free survival is defined as time from registration to the appearance of a distant metastasis confirmed radiographically and/or pathologically or death from any cause
Overall survival
Overall survival is defined as time from registration to date of death or last follow-up
Sponsors and contacts
Click on the lead sponsor to view all of their trials.