Omitting radiation therapy for certain breast cancer patients 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 observational study aims to evaluate the omission of adjuvant whole breast radiation therapy (WBRT) in women with clinically node negative breast cancer who achieve a pathological complete response (pCR) after neoadjuvant chemotherapy and breast conserving surgery. It is a prospective, multi-center, single arm cohort study that will enroll female patients with newly diagnosed T1-3 node negative breast cancer, following specific eligibility criteria. Participants will be monitored for ipsilateral breast tumor recurrence and other outcomes over a median follow-up period of 5 years, without receiving the standard adjuvant WBRT treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type).
2. Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy.
3. Treated with a minimum of 8 weeks NAC, with patients with Her2+ disease receiving targeted anti-Her2+ therapy.
4. Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified.
5. Treated by BCS with complete excision of the tumour bed and axillary staging surgery (either sentinel lymph node biopsy or axillary lymph node dissection).
6. Final pathology demonstrating a pCR \[defined as absence of residual invasive and in-situ breast cancer within the breast or lymph nodes (ypT0N0)\].

Exclusion Criteria:

1. Age less than 50 years.
2. Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4 disease).
3. Multicentric disease (i.e., breast cancer involving more than one quadrant in the same breast).
4. Prior history of ipsilateral or contralateral in-situ or invasive breast cancer. Patients with a history of lobular carcinoma in-situ (LCIS) are ineligible.
5. Synchronous contralateral in-situ or invasive breast cancer.
6. BRCA (breast cancer gene) 1 or 2 genetic mutation carrier, or other genetic mutation present associated with increased risk of breast cancer.
7. Other previous non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers or other cancers curatively treated with no evidence of disease for ≥ 5 years.
8. Inability to complete entire course of neoadjuvant therapy (minimum of 8 weeks of treatment).
9. Patients with HR+ (hormone receptor) disease who are not planned to have endocrine therapy initiated.
10. Patients with Her2+ disease who have not received or are not planned to receive Her2 targeted therapy.
11. ECOG (Eastern Cooperative Oncology Group) performance status \> 3.
12. Inability to provide informed consent.

Where it's running

• Tweed Valley Hospital
  Cudgen, Cudgen, Australia Recruiting
• Liverpool Hospital
  Liverpool, New South Wales, Australia Recruiting
• Mater Hospital Sydney
  North Sydney, New South Wales, Australia Recruiting
• Westmead Hospital
  Westmead, New South Wales, Australia Recruiting
• Royal Brisbane and Women's Hospital
  Herston, Queensland, Australia Recruiting
• Princess Alexandra Hospital
  Woolloongabba, Queensland, Australia Recruiting

Study contacts

• Principal investigator: Elena Parvez, MD — Juravinski Cancer Centre
• Study coordinator: Adrianne Van Dam
• Email: avandam@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.