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
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring radiation therapy
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
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
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
Learn more about this trial
Single Pre-Operative Radiation Therapy - With Delayed Surgery for Low Risk Breast Cancer
We'll reach out to this number within 24 hrs