Breast-preserving treatment using repeat radiation for recurrent breast cancer

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.