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Clinical Trials/NCT03917498
NCT03917498Active, not recruitingNot Applicable

Single Pre-Operative Radiation Therapy - With Delayed Surgery (SPORT-DS) for Low Risk Breast Cancer: A Phase 1 Study

Michael Yassa2 sites in 1 country20 target enrollmentStarted: April 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
20
Locations
2
Primary Endpoint
rate of pathological complete response

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

rate of pathological complete response

Time Frame: at the time of surgery

Secondary Outcomes

  • incidence of radiation toxicity(in the 2 years after treatment)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Michael Yassa

Radiation Oncologist

Maisonneuve-Rosemont Hospital

Study Sites (2)

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