Breast-preserving treatment using repeat radiation for recurrent breast cancer
Study on Recurrent Breast Cancer and Repeated Radiation Therapy
The trial will try breast-conserving surgery plus repeat radiation to see if people 55 or older with a small, local recurrent breast cancer can safely keep their breast instead of having a mastectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 55 Years and up |
| Sex | Female |
| Sponsor | Turku University Hospital Government |
| Drugs / interventions | radiation |
| Locations | 2 sites (Helsinki and 1 other locations) |
| Trial ID | NCT06704659 on ClinicalTrials.gov |
What this trial studies
This interventional study will enroll 30 patients at Turku and Helsinki University Hospitals who have a local breast cancer recurrence after prior breast-conserving surgery and radiation. Eligible patients are at least 55 years old, have a tumor no larger than 3 cm with no evidence of regional or distant metastasis (N0M0), and completed prior radiotherapy at least three years earlier; prior receipt of a boost dose excludes enrollment. Participants undergo repeat breast-conserving surgery planned without contralateral tissue transfer followed by carefully planned re-irradiation following standard radiotherapy techniques. The study will collect safety, surgical, radiation planning, and patient outcome data to inform strategies for breast preservation in the recurrent setting.
Who should consider this trial
Good fit: Ideal candidates are patients aged 55 or older with a single local breast recurrence ≤3 cm, no evidence of metastasis (N0M0), at least three years since prior whole-breast irradiation, prior breast-conserving surgery, and a tumor that can be removed without complex tissue transfer.
Not a fit: Patients who received a prior radiotherapy boost, have multifocal disease, tumors larger than 3 cm, metastatic disease, or who cannot achieve a breast-conserving resection are unlikely to benefit from repeat breast conservation.
Why it matters
Potential benefit: If successful, this approach could allow selected patients to keep their breast after a local recurrence, reducing the need for mastectomy and improving cosmetic outcomes and quality of life.
How similar studies have performed: Small series and institutional reports have suggested repeat breast-conserving surgery with re-irradiation can be feasible and safe in selected patients, but high-quality randomized data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient has a diagnosed breast cancer or tumor area in the breast with a maximum diameter of 3 cm, where a previous breast-conserving surgery has been performed (either invasive breast cancer or carcinoma in situ, DCIS). The patient has only a local recurrence, and imaging studies show no suspicion of metastases outside the breast (preoperative staging N0M0). At least 3 years have passed since the completion of prior radiation therapy. The new breast cancer can be technically treated with another breast-conserving surgery using a technique that does not require tissue transfer from areas opposite the removed tumor to restore the shape of the breast. The patient is at least 55 years old at the time of surgery. The patient is willing to participate in the study. The patient is capable of providing informed consent. Exclusion Criteria: * A booster dose, also known as a "boost," was administered during prior radiation therapy. Preoperative assessments suggest multifocal breast cancer, with the tumor area to be removed exceeding 3 cm. The planned radiation therapy per the study protocol cannot be administered due to factors such as shoulder joint stiffness, a pacemaker located in the radiation field, or a skin condition (e.g., scleroderma). The patient is unable to provide informed consent or is unwilling to participate in the study. Metastases outside the breast (e.g., axillary or distant metastases) are present.
Where this trial is running
Helsinki and 1 other locations
- Helsinki University Hospital — Helsinki, Finland (Recruiting)
- Turku University Hospital — Turku, Finland (Recruiting)
Study contacts
- Study coordinator: Anselm Tamminen, MD, PhD
- Email: jlatam@utu.fi
- Phone: +3583130000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.