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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Single Pre-Operative Radiation Therapy - with Delayed Surgery
Sponsored by
Michael Yassa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring radiation therapy

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Maisonneuve-Rosemont Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Pre-Operative Radiation Therapy with Delayed Surgery

Arm Description

Single Pre-Operative Radiation Therapy with Delayed Surgery

Outcomes

Primary Outcome Measures

rate of pathological complete response

Secondary Outcome Measures

incidence of radiation toxicity

Full Information

First Posted
April 11, 2019
Last Updated
August 30, 2021
Sponsor
Michael Yassa
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1. Study Identification

Unique Protocol Identification Number
NCT03917498
Brief Title
Single Pre-Operative Radiation Therapy - With Delayed Surgery for Low Risk Breast Cancer
Acronym
SPORT-DS
Official Title
Single Pre-Operative Radiation Therapy - With Delayed Surgery (SPORT-DS) for Low Risk Breast Cancer: A Phase 1 Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Yassa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
radiation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Pre-Operative Radiation Therapy with Delayed Surgery
Arm Type
Experimental
Arm Description
Single Pre-Operative Radiation Therapy with Delayed Surgery
Intervention Type
Radiation
Intervention Name(s)
Single Pre-Operative Radiation Therapy - with Delayed Surgery
Intervention Description
Single Pre-Operative Radiation Therapy - with Delayed Surgery
Primary Outcome Measure Information:
Title
rate of pathological complete response
Time Frame
at the time of surgery
Secondary Outcome Measure Information:
Title
incidence of radiation toxicity
Time Frame
in the 2 years after treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female aged 65 years or older World Health Organization (WHO) performance status 0-2 Invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start Unifocal disease on preoperative staging ultrasound done ≤ 12 weeks from treatment start Tumors less than 2cm clinically on physical exam, as well as on breast ultrasound No clinical evidence of nodal disease (i.e. cN0), on physical examination done ≤ 12 weeks from treatment start, as well as on breast ultrasound Estrogen receptor status (ER) positive on biopsy Her2 negative on biopsy Grade 1 or 2 on biopsy Planned surgery is a partial mastectomy with sentinel lymph node biopsy Localisation markers placed before treatment Exclusion Criteria: Age less than 65 years A known deleterious mutation in BRCA 1 and/or BRCA 2 Clinical tumor size > 2.0 cm in greatest diameter on staging ultrasound Tumor histology limited to lobular carcinoma only Clinically positive axillary nodes (cN+) Lymphovascular invasion on biopsy Pure ductal or lobular carcinoma in situ on biopsy Extensive intraductal component on biopsy Neoadjuvant hormonal manipulation or chemotherapy Prior history of cancer (Patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial) More than one primary tumor in different quadrants of the same breast Diffuse microcalcifications on mammography Paget's disease of the nipple Previous irradiation to the ipsilateral breast Presence of an ipsilateral breast implant or pacemaker Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment Estrogen receptor status (ER) not known Currently pregnant or lactating Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol Geographic inaccessibility for follow-up Lack of preoperative staging with breast and axillary ultrasound Inability to adequately plan the patient for the experimental technique
Facility Information:
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada

12. IPD Sharing Statement

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

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