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

November 18, 2024 updated by: Michael Yassa

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: at the time of surgery
at the time of surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Yassa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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