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Radiation Therapy

Pre-Operative Radiation Therapy for Breast Cancer (SPORT-DS Trial)

N/A
Waitlist Available
Research Sponsored by Michael Yassa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tumors less than 2cm clinically on physical exam, as well as on breast ultrasound
World Health Organization (WHO) performance status 0-2
Must not have
Age less than 65 years
Previous irradiation to the ipsilateral breast
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether giving a single dose of radiotherapy to low-risk breast tumours 3 months before surgery is effective.

Who is the study for?
This trial is for women aged 65 or older with low-risk breast cancer. Eligible participants have a small tumor (less than 2cm), no nodal disease, positive estrogen receptor status, negative Her2, and are planning partial mastectomy. Exclusions include prior cancers (except certain skin cancers), large tumors, lobular carcinoma only, positive lymph nodes, and serious non-cancer illnesses.
What is being tested?
The study tests a single dose of preoperative partial radiotherapy given three months before surgery on patients with low-risk breast tumors. It aims to assess the effectiveness and safety of this approach compared to traditional treatment timelines.
What are the potential side effects?
Potential side effects may include skin changes at the radiation site, fatigue, mild swelling or tenderness in the treated area. More serious but less common risks involve damage to nearby organs like the heart or lungs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is smaller than 2cm according to a physical exam and ultrasound.
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I can take care of myself and perform light activities.
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I am a woman aged 65 or older.
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I am scheduled for a partial mastectomy and sentinel lymph node biopsy.
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My biopsy shows my cancer is estrogen receptor positive.
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My biopsy shows I am HER2 negative.
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My biopsy results show low to moderate abnormality.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 65 years old.
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I have had radiation therapy on the same side breast before.
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My underarm lymph nodes are affected by cancer.
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My cancer's estrogen receptor status is unknown.
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I have a harmful BRCA1 or BRCA2 gene mutation.
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My tumor is larger than 2 cm according to an ultrasound.
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I have multiple primary tumors in different areas of the same breast.
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My cancer is specifically lobular carcinoma.
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I do not have a serious illness like heart or lung disease that would prevent me from receiving radiation therapy.
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I have Paget's disease of the nipple.
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My biopsy shows I have a non-invasive type of breast cancer.
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I did not have a breast and underarm ultrasound before surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Pre-Operative Radiation Therapy with Delayed SurgeryExperimental Treatment1 Intervention
Single Pre-Operative Radiation Therapy with Delayed Surgery

Find a Location

Who is running the clinical trial?

Michael YassaLead Sponsor
~3 spots leftby Nov 2025
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