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Completed

NCT Number: NCT01717261

Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer

The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female aged 60 years or older.
  • Invasive ductal carcinoma.
  • Unifocal disease.
  • Tumors less than 2cm.
  • No clinical evidence of nodal disease.
  • Estrogen receptor status (ER) positive.
  • Her2 negative.

Exclusion criteria

  • Age less than 60 years.
  • BRCA 1 and/or BRCA 2 mutation.
  • Tumour histology limited to lobular carcinoma only.
  • Neoadjuvant hormonal manipulation or chemotherapy.
  • More than one primary tumour in different quadrants of the same breast.
  • Inability to view tumor on imaging.

Treatment and study plan

Single Pre-Operative Radiation Therapy

Radiation

Dose escalation: 3 patients will receive 15 Gy in a single fraction. The following 3 patients will receive 18 Gy. The final 4 patients will receive 20 Gy.

Primary outcomes

  1. Acute toxicity

    Time frame: 6 months

    Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.

Secondary outcomes

  1. Chronic toxicity

    Time frame: 2 years

    Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale

  2. Cosmetic outcome

    Time frame: 5 years

    Cosmesis will be evaluated as per the EORTC Breast Cancer Cosmetic Rating scale.

Other outcomes

  1. Ipsilateral breast cancer recurrence

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Registry information

Acronym: SPORT

Important dates

Study start
2012
Primary completion
2018
Study completion
2023
First posted
Oct 30, 2012
Registry last updated
Nov 1, 2023

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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