Phase II Single Vs Hypofractionated Irradiation for Timely Access to Partial Breast Radiotherapy

Launched by BRITISH COLUMBIA CANCER AGENCY · Mar 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to deliver partial breast radiation therapy (PBI) to women with early-stage breast cancer after they have had surgery to remove their tumor. PBI targets the area where the tumor was located, which helps minimize radiation exposure to nearby organs like the lungs and heart. The trial will compare a single dose of radiation (single fraction) to the traditional method that involves multiple doses over a longer period (multiple fraction). This is important because many women, especially those living in rural areas, may find it difficult to travel for treatment that takes a long time.

To participate in the trial, women must be 40 years or older, have a specific type of early-stage breast cancer (less than 3 cm in size), and be able to provide consent for themselves. Participants will need to complete some questionnaires about their health, and they should be able to stay still during their treatment. Women who are pregnant or have certain medical conditions may not be eligible. This trial is still in the planning phase and has not started enrolling participants yet. If you or a loved one meet the criteria and are interested in learning more, it could be a good option to explore.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female participants age 40 or older
• • Able to provide informed consent
• • pTis-2 pN0 cM0 breast cancer less than 3 cm in maximum size
• • Able to complete electronic or paper entry of participant reported outcomes independently or with assistance from caregiver/family/friend/research staff
• • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
• • A history and physical examination, including ECOG performance status, performed within 8 weeks prior to enrollment.
• * Participant is judged able to:
• • Maintain a stable position during therapy
• • Tolerate immobilization device(s) that may be required to deliver PBI safely
• • Negative pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of RT start date
• Exclusion Criteria:
• • History of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for ≥ 5 years.
• • Seroma not visible
• • Ipsilateral implanted cardiac device
• • Prior radiotherapy requiring summation for planning.
• • Requirement for a radiation boost (as determined by the treating investigator)
• • Positive lymph nodes \> 3 cm
• • Positive surgical margins
• • Surgical cavities lacking clear delineation
• • Known germline BRCA1/2 mutation.
• • Serious medical comorbidities precluding radiotherapy (e.g., connective tissue disorders such as lupus or scleroderma)
• • Pregnant or breastfeeding