Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS) (SPORT-DNS)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Radiation: Single Pre-Operative Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring ablative radiotherapy, preoperative radiotherapy, neoadjuvant radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Female aged 50 years or older.
- Postmenopausal status (Defined as: age 60 OR bilateral ovariectomy OR amenorrhea > 12 months prior to breast cancer diagnosis without using oral contraceptives/hormone replacement therapy) (65).
- 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 or MRI done ≤ 12 weeks from treatment start.
- Tumors less than or equal to 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 ≥ 80%.
- Progesterone receptor status (PR) positive on biopsy ≥ 20%.
- Her2 negative on biopsy.
- No lymphovascular invasion on biopsy.
- Low Oncotype DX recurrence score performed on biopsy specimen (RS ≤18).
- Planned surgery is a partial mastectomy with sentinel lymph node biopsy.
Exclusion Criteria:
- Age less than 50 years.
- Premenopausal or uncertain menopausal status.
- 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 non basal cell or squamous cell skin cancers within 5 years.
- 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.
- Prior breast cancer.
Sites / Locations
- Maisonneuve-Rosemont HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Preoperative radiotherapy for early breast cancer
Arm Description
Radiation: Single Pre-Operative Radiation Therapy
Outcomes
Primary Outcome Measures
Incidence of pathological complete response
Secondary Outcome Measures
Incidence of grade 3 or greater radiation toxicity
Full Information
NCT ID
NCT05217966
First Posted
January 18, 2022
Last Updated
January 31, 2022
Sponsor
Maisonneuve-Rosemont Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05217966
Brief Title
Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS)
Acronym
SPORT-DNS
Official Title
Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS) for Low Risk Breast Cancer: A Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maisonneuve-Rosemont Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Eligible women will receive neoadjuvant single fraction radiotherapy followed by surgery performed after one year
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
ablative radiotherapy, preoperative radiotherapy, neoadjuvant radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preoperative radiotherapy for early breast cancer
Arm Type
Experimental
Arm Description
Radiation: Single Pre-Operative Radiation Therapy
Intervention Type
Radiation
Intervention Name(s)
Radiation: Single Pre-Operative Radiation Therapy
Intervention Description
Ablative preoperative partial breast radiation therapy
Primary Outcome Measure Information:
Title
Incidence of pathological complete response
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence of grade 3 or greater radiation toxicity
Time Frame
0-5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female aged 50 years or older.
Postmenopausal status (Defined as: age 60 OR bilateral ovariectomy OR amenorrhea > 12 months prior to breast cancer diagnosis without using oral contraceptives/hormone replacement therapy) (65).
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 or MRI done ≤ 12 weeks from treatment start.
Tumors less than or equal to 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 ≥ 80%.
Progesterone receptor status (PR) positive on biopsy ≥ 20%.
Her2 negative on biopsy.
No lymphovascular invasion on biopsy.
Low Oncotype DX recurrence score performed on biopsy specimen (RS ≤18).
Planned surgery is a partial mastectomy with sentinel lymph node biopsy.
Exclusion Criteria:
Age less than 50 years.
Premenopausal or uncertain menopausal status.
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 non basal cell or squamous cell skin cancers within 5 years.
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.
Prior breast cancer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josée Abi-Saad
Phone
514-252-3400
Ext
3227
Email
josee.abi-saad.cemtl@ssss.gouv.qc.ca
Facility Information:
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Yassa, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS)
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