RecruitingNot Applicable

Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS)

Canada80 participantsStarted 2021-10-08

Plain-language summary

Eligible women will receive neoadjuvant single fraction radiotherapy followed by surgery performed after one year

Age range50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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%.

Incidence of pathological complete response

Timeframe: 12 months

NCT IDNCT05217966

SponsorMaisonneuve-Rosemont Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Michael Yassa

Who can participate

Age range50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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%.