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

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

This study is testing a new way to treat women with recurring breast cancer by using targeted radiation again to see if it can help them keep their breast instead of needing surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Meldola, Forlì Cesena)
• Trial ID: NCT05772390 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women over 18 years old with isolated, unifocal breast lesions that are less than 2 cm in size and have undergone prior conservative surgery and whole breast irradiation.

Not a fit: Patients with distant metastases or those who do not meet the specific eligibility criteria, such as having positive margins or axillary lymph node involvement, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive treatment option that preserves the breast and improves quality of life for women with recurrent breast cancer.

How similar studies have performed: Other studies have shown promising results with partial breast re-irradiation as a viable alternative to mastectomy, indicating that this approach is gaining traction in clinical practice.

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;

Where this trial is running

Meldola, Forlì Cesena

• UO Radioterapia, IRST IRCCS — Meldola, Forlì Cesena, Italy (Recruiting)

Study contacts

• Study coordinator: Oriana Nanni

Conditions Breast Cancer; Recurrent; Partial re-irradiation; recurrent breast cancer; conservative surgery