Comparing two types of breast radiation therapy after surgery

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 clinical trial aims to compare the effectiveness of Partial Breast Irradiation (PBI) versus Whole Breast Irradiation (WBI) in women with node-negative breast cancer that is 3 cm or smaller. Participants will be randomly assigned to receive either treatment after undergoing breast-conserving surgery. The study will assess local recurrence rates and patient-reported cosmetic outcomes three years after treatment. The trial is designed to ensure that participants are unaware of their treatment allocation to minimize bias in their assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

For inclusion in this study, patients must fulfill all of the following criteria:

1. Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging, Appendix II).
2. Treated by BCS with microscopically clear resection margins \>= 1mm for invasive and non-invasive disease or no residual disease on re-excision.
3. Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection or clinical assessment with a negative axillary ultrasound and/or biopsy, for women with unifocal tumours \<= 2cm, histologic grade 1 or 2, ER or PR+ and HER2-ve that are being planned for endocrine therapy

Exclusion Criteria:

Patients who satisfy any of the following exclusion criteria are NOT eligible for this study:

1. Age less than 50 years.
2. Known to be BRCA 1 and/or BRCA 2 positive.
3. Tumour size \>3cm in greatest diameter on pathological examination.
4. Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least 25% and extending beyond the invasive component to surrounding normal breast tissue) with the following exception: smaller tumours with EIC where the combined size (of the invasive and DCIS components) are \<= 3cm remain eligible
5. Evidence of a DCIS component \> 3cm
6. Lobular carcinoma only.
7. More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).
8. Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).
9. History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.
10. Known pregnancy or currently lactating.
11. Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).
12. Inability to plan the patient for the experimental technique.

Where it's running

• GenesisCare Darlinghurst
  Darlinghurst, New South Wales, Australia Recruiting
• GenesisCare Hurstville
  Hurstville, New South Wales, Australia Recruiting
• GenesisCare Mater Hospital
  North Sydney, New South Wales, Australia Recruiting
• GenesisCare Bundaberg
  Bundaberg, Queensland, Australia Recruiting
• GenesisCare Southport
  Southport, Queensland, Australia Recruiting
• GenesisCare Tugun
  Tugun, Queensland, Australia Recruiting

Study contacts

• Principal investigator: Timothy Whelan, M.D. — Juravinski Cancer Centre and McMaster University
• Study coordinator: Shelley Chambers, MA
• Email: schamber@mcmaster.ca
• Phone: 905-527-2299

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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.