Pre-operative radiation therapy for breast cancer with delayed surgery

Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS) for Low Risk Breast Cancer: A Phase II Study

This study is testing whether giving one dose of radiation therapy before surgery can help postmenopausal women with certain types of breast cancer feel better and have better outcomes, even if their surgery is delayed for a year.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 50 Years and up
• Sex: Female
• Sponsor: Maisonneuve-Rosemont Hospital (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Montreal, Quebec and 1 other locations)
• Trial ID: NCT05217966 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of a single fraction of pre-operative radiation therapy in women with breast cancer, followed by surgery that occurs after a one-year delay. Eligible participants are postmenopausal women aged 50 and older with specific tumor characteristics, including unifocal invasive ductal carcinoma and favorable hormone receptor status. The study aims to evaluate the safety and efficacy of this approach in potentially improving patient outcomes. Participants will receive radiation treatment before surgery, allowing for a novel approach to managing their condition.

Who should consider this trial

Good fit: Ideal candidates for this study are postmenopausal women aged 50 years or older with specific characteristics of breast cancer, including unifocal invasive ductal carcinoma and favorable hormone receptor status.

Not a fit: Patients with advanced breast cancer, those with evidence of nodal disease, or those with tumors larger than 2cm may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for women with breast cancer by allowing for effective tumor control while delaying surgery.

How similar studies have performed: While the approach of using pre-operative radiation therapy is established, the specific methodology of delayed surgery following single fraction radiation is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Female aged 50 years or older.
2. Postmenopausal status (Defined as: age 60 OR bilateral ovariectomy OR amenorrhea \> 12 months prior to breast cancer diagnosis without using oral contraceptives/hormone replacement therapy) (65).
3. World Health Organization (WHO) performance status 0-2.
4. Invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start.
5. Unifocal disease on preoperative staging ultrasound or MRI done ≤ 12 weeks from treatment start.
6. Tumors less than or equal to 2cm clinically on physical exam, as well as on breast ultrasound.
7. No clinical evidence of nodal disease (i.e. cN0), on physical examination done ≤ 12 weeks from treatment start, as well as on breast ultrasound.
8. Estrogen receptor status (ER) positive on biopsy ≥ 80%.
9. Progesterone receptor status (PR) positive on biopsy ≥ 20%.
10. Her2 negative on biopsy.
11. No lymphovascular invasion on biopsy.
12. Low Oncotype DX recurrence score performed on biopsy specimen (RS ≤18).
13. Planned surgery is a partial mastectomy with sentinel lymph node biopsy.

Exclusion Criteria:

1. Age less than 50 years.
2. Premenopausal or uncertain menopausal status.
3. A known deleterious mutation in BRCA 1 and/or BRCA 2.
4. Clinical tumor size \> 2.0 cm in greatest diameter on staging ultrasound.
5. Tumor histology limited to lobular carcinoma only.
6. Clinically positive axillary nodes (cN+).
7. Lymphovascular invasion on biopsy.
8. Pure ductal or lobular carcinoma in situ on biopsy.
9. Extensive intraductal component on biopsy.
10. Neoadjuvant hormonal manipulation or chemotherapy.
11. Prior non basal cell or squamous cell skin cancers within 5 years.
12. More than one primary tumor in different quadrants of the same breast.
13. Diffuse microcalcifications on mammography.
14. Paget's disease of the nipple.
15. Previous irradiation to the ipsilateral breast.
16. Presence of an ipsilateral breast implant or pacemaker.
17. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
18. Estrogen receptor status (ER) not known.
19. Currently pregnant or lactating.
20. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol.
21. Geographic inaccessibility for follow-up.
22. Lack of preoperative staging with breast and axillary ultrasound.
23. Inability to adequately plan the patient for the experimental technique.
24. Prior breast cancer.

Where this trial is running

Montreal, Quebec and 1 other locations

• Maisonneuve-Rosemont Hospital — Montreal, Quebec, Canada (Recruiting)
• McGill University Health Center — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Michael Yassa

Conditions Breast Cancer; ablative radiotherapy; preoperative radiotherapy; neoadjuvant radiotherapy