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

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ClinicalTrials.gov Identifier: NCT03917498
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Yassa, Maisonneuve-Rosemont Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Single Pre-Operative Radiation Therapy - with Delayed Surgery Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Pre-Operative Radiation Therapy - With Delayed Surgery (SPORT-DS) for Low Risk Breast Cancer: A Phase 1 Study
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Single Pre-Operative Radiation Therapy with Delayed Surgery
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




Primary Outcome Measures :
  1. rate of pathological complete response [ Time Frame: at the time of surgery ]

Secondary Outcome Measures :
  1. incidence of radiation toxicity [ Time Frame: in the 2 years after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917498


Locations
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Canada, Quebec
Maisonneuve-Rosemont Hospital Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Linda Roy-Huneault    5142523425    lroyhuneault.hmr@ssss.gouv.qc.ca   
Principal Investigator: Michael Yassa, MD         
Sponsors and Collaborators
Michael Yassa

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Responsible Party: Michael Yassa, Radiation Oncologist, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT03917498     History of Changes
Other Study ID Numbers: SPORT-DS
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Yassa, Maisonneuve-Rosemont Hospital:
radiation therapy

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases