NCT05772390 Partial Breast Re-irradiation in Women in Women with Locally Recurrent Breast Cancer Previously Treated with Conservative Surgery and Whole Breast Irradiation
| NCT ID | NCT05772390 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2023-03-31 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 68 participants in total. It began in 2023-03-31 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A prospective study of partial breast re-irradiation in patients with local recurrence of breast cancer
Eligibility Criteria
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) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and bone scan (if clinically relevant); 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. 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 RT performed with IORT, brachytherapy or previous partial breast treatment; 5. Known pathogenic mutation of BRCA1, BRCA2 or TP53 gene; 6. Patients who had chemotherapy within 2 weeks prior to study RT; 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 RT 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;
Contact & Investigator
Simona Cima
STUDY CHAIR
IRCCS IRST
Frequently Asked Questions
Who can join the NCT05772390 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05772390 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05772390 currently recruiting?
Yes, NCT05772390 is actively recruiting participants. Contact the research team at oriana.nanni@irst.emr.it for enrollment information.
Where is the NCT05772390 trial being conducted?
This trial is being conducted at Meldola, Italy.
Who is sponsoring the NCT05772390 clinical trial?
NCT05772390 is sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS. The principal investigator is Simona Cima at IRCCS IRST. The trial plans to enroll 68 participants.
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