Breast Cancer Clinical Trial
— PBReIOfficial title:
Partial Breast Re-irradiation in Women With Locally Recurrent Breast Cancer Previously Treated With Conservative Surgery and Whole Breast Irradiation: A Prospective Phase II Clinical Study
A prospective study of partial breast re-irradiation in patients with local recurrence of breast cancer
Status | Recruiting |
Enrollment | 68 |
Est. completion date | March 2032 |
Est. primary completion date | March 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Isolated ipsilateral unifocal breast lesions; 2. Histologically confirmed invasive breast carcinoma or carcinoma in situ; 3. Limited size (< 2 cm) without evidence of skin involvement; 4. Negative histologic margins of resection; 5. Negative axillary lymph nodes; 6. No synchronous distant metastases; 7. Bilateral breast mammogram or MRI within 120 days prior to study entry; 8. 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; 9. = 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: 1. Regional recurrences (axillary, supraclavicular); 2. Positive histologic margins at resection; 3. Metastatic disease; 4. Previous breast Radiotherapy performed with Intraoperative radiotherapy, brachytherapy or previous partial breast treatment; 5. Known pathogenic mutation of BRCA1, BRCA2 or Tumor Protein 53 gene; 6. Patients who had chemotherapy within 2 weeks prior to study Radiotherapy; 7. Participation in another clinical trial with any investigational agents within 30 days prior to study screening; 8. 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; 9. 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 |
Country | Name | City | State |
---|---|---|---|
Italy | UO Radioterapia, IRST IRCCS | Meldola | Forlì Cesena |
Lead Sponsor | Collaborator |
---|---|
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 12 months | |
Secondary | 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 | 5 years | |
Secondary | 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 | 5 years | |
Secondary | 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 | 5 years | |
Secondary | Overall survival | Overall survival is defined as time from registration to date of death or last follow-up | 5 years | |
Secondary | Patient satisfaction | Patients satisfaction is assessed with the Breast-Q questionnaire (from 0 (worst) to 100 (best). Higher scores reflect a better outcome) | 5 years |
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