Clinical Trials /

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

NCT03917498

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: SPORT-DS
  • NCT ID: NCT03917498

Conditions

  • Breast Cancer

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Single Pre-Operative Radiation Therapy with Delayed SurgeryExperimentalSingle Pre-Operative Radiation Therapy with Delayed Surgery

    Eligibility Criteria

            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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:65 Years
    Eligible Gender:Female
    Healthy Volunteers:Accepts Healthy Volunteers

    Primary Outcome Measures

    Measure:rate of pathological complete response
    Time Frame:at the time of surgery
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:incidence of radiation toxicity
    Time Frame:in the 2 years after treatment
    Safety Issue:
    Description:

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Michael Yassa

    Trial Keywords

    • radiation therapy

    Last Updated