Single Pre-Operative Radiation Therapy - With Delayed Surgery for Low Risk Breast Cancer (SPORT-DS)

Single Pre-Operative Radiation Therapy - With Delayed Surgery (SPORT-DS) for Low Risk Breast Cancer: A Phase 1 Study

To study a single dose of preoperative partial radiotherapy to a low-risk breast tumour. The radiotherapy will be goven 3 months before surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Single Pre-Operative Radiation Therapy - with Delayed Surgery

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Maisonneuve-Rosemont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Female aged 65 years or older
2. World Health Organization (WHO) performance status 0-2
3. Invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start
4. Unifocal disease on preoperative staging ultrasound done ≤ 12 weeks from treatment start
5. Tumors less than 2cm clinically on physical exam, as well as on breast ultrasound
6. No clinical evidence of nodal disease (i.e. cN0), on physical examination done ≤ 12 weeks from treatment start, as well as on breast ultrasound
7. Estrogen receptor status (ER) positive on biopsy
8. Her2 negative on biopsy
9. Grade 1 or 2 on biopsy
10. Planned surgery is a partial mastectomy with sentinel lymph node biopsy
11. Localisation markers placed before treatment

Exclusion Criteria:

1. Age less than 65 years
2. A known deleterious mutation in BRCA 1 and/or BRCA 2
3. Clinical tumor size > 2.0 cm in greatest diameter on staging ultrasound
4. Tumor histology limited to lobular carcinoma only
5. Clinically positive axillary nodes (cN+)
6. Lymphovascular invasion on biopsy
7. Pure ductal or lobular carcinoma in situ on biopsy
8. Extensive intraductal component on biopsy
9. Neoadjuvant hormonal manipulation or chemotherapy
10. Prior history of cancer (Patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial)
11. More than one primary tumor in different quadrants of the same breast
12. Diffuse microcalcifications on mammography
13. Paget's disease of the nipple
14. Previous irradiation to the ipsilateral breast
15. Presence of an ipsilateral breast implant or pacemaker
16. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment
17. Estrogen receptor status (ER) not known
18. Currently pregnant or lactating
19. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol
20. Geographic inaccessibility for follow-up
21. Lack of preoperative staging with breast and axillary ultrasound
22. Inability to adequately plan the patient for the experimental technique

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Pre-Operative Radiation Therapy with Delayed Surgery	Radiation: Single Pre-Operative Radiation Therapy - with Delayed Surgery; Single Pre-Operative Radiation Therapy - with Delayed Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
rate of pathological complete response	at the time of surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
incidence of radiation toxicity	in the 2 years after treatment

Collaborators and Investigators

• Sponsor: Michael Yassa

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: radiation therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SPORT-DS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No