Single Pre-Operative Radiation Therapy - With Delayed Surgery for Low Risk Breast Cancer

Breast Cancer Clinical Trial

— SPORT-DS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03917498
• Other study ID #: SPORT-DS
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Single Pre-Operative Radiation Therapy - with Delayed Surgery
Single Pre-Operative Radiation Therapy - with Delayed Surgery

Locations

Country	Name	City	State
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Michael Yassa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of pathological complete response		at the time of surgery
Secondary	incidence of radiation toxicity		in the 2 years after treatment