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NCT Number: NCT03917498

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

To study a single dose of preoperative partial radiotherapy to a low-risk breast tumour. The radiotherapy will be goven 3 months before surgery.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single Pre-Operative Radiation Therapy - with Delayed Surgery

Radiation

Single Pre-Operative Radiation Therapy - with Delayed Surgery

Primary outcomes

  1. rate of pathological complete response

    Time frame: at the time of surgery

Secondary outcomes

  1. incidence of radiation toxicity

    Time frame: in the 2 years after treatment

Sponsors and collaborators

Lead sponsor

Michael Yassa

Other

Registry information

Official study title

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

Acronym: SPORT-DS

Important dates

Study start
2018
Primary completion
2020
Study completion
2025
First posted
Apr 17, 2019
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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