Partial Breast Re-irradiation for Breast Cancer

Launched by UNIVERSITY HOSPITAL HEIDELBERG · Apr 24, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for women with breast cancer who have had a recurrence after previous radiation therapy. Specifically, the study is looking at the use of proton beam therapy, which is a type of radiation treatment that targets the cancer more precisely, potentially reducing side effects. The trial will include 20 women who have been diagnosed with invasive breast cancer that has returned after surgery and radiation, and who are eligible for a repeat surgery. To participate, women must be between 18 and 74 years old, have a tumor smaller than 3 cm, and have had at least 12 months since their last radiation treatment.

Participants in this trial can expect to receive a targeted radiation treatment for their breast cancer over the course of 15 days. The main goal of the study is to monitor any serious skin reactions that may occur within six months after starting the treatment. It’s important to note that women with distant cancer spread, certain health conditions, or those currently receiving other types of chemotherapy may not be eligible to join the trial. This study is not yet recruiting participants, but it represents an innovative approach to managing breast cancer recurrences and aims to improve treatment options for patients in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • histologically confirmed recurrent (or new primary) ipsilateral invasive breast cancer or DCIS after prior RT of the ipsilateral breast
• • indication for re-irradiation after repeat breast conserving surgery (e.g. lumpectomy, wide excision, ...)
• • tumor size \< 3 cm
• • clinically node-negative (cN0)
• • negative resection margin (R0)
• • time interval: start of re-RT to prior RT ≥ 12 months
• • ECOG Performance status ≤ 2
• • ability of subject to understand character and individual consequences of the clinical trial
• • written informed consent
• • ≥18 years of age
• Exclusion Criteria:
• • distant metastases
• • concomitant chemotherapy (concomitant endocrine hormonal therapy is allowed; sequential chemotherapy is allowed)
• • patients who have not recovered from acute toxicities of prior therapies
• • known carcinoma \< 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
• • pregnant or lactating women
• • participation in another competing clinical study or observation period of competing trials
• • history of active connective tissue disorder (i.e. systemic lupus erythematosus, scleroderma, dermatomyositis, xeroderma pigmentosum, ...)
• • medical implants, which are at the time of reirradiation not eligible for particle therapy at Heidelberg Ion Beam Therapy Center