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New treatment option for Breast Cancer
Official title Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS)
ClinicalTrials.gov ID: NCT05217966
What this study is testing
- What it's testing
- Eligible women will receive neoadjuvant single fraction radiotherapy followed by surgery performed after one year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, women only
You may be able to join if
- Female aged 50 years or older.
- Postmenopausal status (Defined as: age 60 OR bilateral ovariectomy OR amenorrhea \> 12 months prior to breast cancer diagnosis without using oral...
- 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 or MRI done ≤ 12 weeks from treatment start.
You likely can't join if
- Age less than 50 years.
- Premenopausal or uncertain menopausal status.
- 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+).
See the full eligibility criteria
- Female aged 50 years or older.
- Postmenopausal status (Defined as: age 60 OR bilateral ovariectomy OR amenorrhea \> 12 months prior to breast cancer diagnosis without using oral contraceptives/hormone replacement therapy) (65).
- 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 or MRI done ≤ 12 weeks from treatment start.
- Tumors less than or equal to 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 ≥ 80%.
- Progesterone receptor status (PR) positive on biopsy ≥ 20%.
- Her2 negative on biopsy.
- No lymphovascular invasion on biopsy.
- Low Oncotype DX recurrence score performed on biopsy specimen (RS ≤18).
- Planned surgery is a partial mastectomy with sentinel lymph node biopsy.
- Age less than 50 years.
- Premenopausal or uncertain menopausal status.
- 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 non basal cell or squamous cell skin cancers within 5 years.
- 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.
- Prior breast cancer.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.