Re-irradiation for women with recurrent breast cancer after previous treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and efficacy of partial breast re-irradiation in women who have experienced a local recurrence of breast cancer after undergoing conservative surgery and whole breast irradiation. The goal is to provide an alternative to mastectomy, which has been the traditional treatment for such recurrences, by allowing for breast preservation. Participants will be selected based on specific criteria, including the size and characteristics of their breast lesions, and will undergo a thorough evaluation before treatment. The study aims to improve quality of life for patients by offering a less invasive treatment option.

Why it matters

Who can join: the full rules

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;

Where it's running

• UO Radioterapia, IRST IRCCS
  Meldola, Forlì Cesena, Italy Recruiting

Study contacts

• Study coordinator: Oriana Nanni
• Email: oriana.nanni@irst.emr.it
• Phone: +390543739266

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.