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

Last updated: November 18, 2024
Sponsor: Maisonneuve-Rosemont Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Radiation: Single Pre-Operative Radiation Therapy

Clinical Study ID

NCT05217966
MP-12-2021-2565
  • Ages > 50
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Female aged 50 years or older.

  2. Postmenopausal status (Defined as: age 60 OR bilateral ovariectomy OR amenorrhea > 12 months prior to breast cancer diagnosis without using oral contraceptives/hormonereplacement therapy) (65).

  3. World Health Organization (WHO) performance status 0-2.

  4. Invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start.

  5. Unifocal disease on preoperative staging ultrasound or MRI done ≤ 12 weeks fromtreatment start.

  6. Tumors less than or equal to 2cm clinically on physical exam, as well as on breastultrasound.

  7. No clinical evidence of nodal disease (i.e. cN0), on physical examination done ≤ 12weeks from treatment start, as well as on breast ultrasound.

  8. Estrogen receptor status (ER) positive on biopsy ≥ 80%.

  9. Progesterone receptor status (PR) positive on biopsy ≥ 20%.

  10. Her2 negative on biopsy.

  11. No lymphovascular invasion on biopsy.

  12. Low Oncotype DX recurrence score performed on biopsy specimen (RS ≤18).

  13. Planned surgery is a partial mastectomy with sentinel lymph node biopsy.

Exclusion

Exclusion Criteria:

  1. Age less than 50 years.

  2. Premenopausal or uncertain menopausal status.

  3. A known deleterious mutation in BRCA 1 and/or BRCA 2.

  4. Clinical tumor size > 2.0 cm in greatest diameter on staging ultrasound.

  5. Tumor histology limited to lobular carcinoma only.

  6. Clinically positive axillary nodes (cN+).

  7. Lymphovascular invasion on biopsy.

  8. Pure ductal or lobular carcinoma in situ on biopsy.

  9. Extensive intraductal component on biopsy.

  10. Neoadjuvant hormonal manipulation or chemotherapy.

  11. Prior non basal cell or squamous cell skin cancers within 5 years.

  12. More than one primary tumor in different quadrants of the same breast.

  13. Diffuse microcalcifications on mammography.

  14. Paget's disease of the nipple.

  15. Previous irradiation to the ipsilateral breast.

  16. Presence of an ipsilateral breast implant or pacemaker.

  17. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupuserythematosus (SLE), scleroderma) which would preclude definitive radiationtreatment.

  18. Estrogen receptor status (ER) not known.

  19. Currently pregnant or lactating.

  20. Psychiatric or addictive disorders which would preclude obtaining informed consentor adherence to protocol.

  21. Geographic inaccessibility for follow-up.

  22. Lack of preoperative staging with breast and axillary ultrasound.

  23. Inability to adequately plan the patient for the experimental technique.

  24. Prior breast cancer.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Radiation: Single Pre-Operative Radiation Therapy
Phase:
Study Start date:
October 08, 2021
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec H1T 2M4
    Canada

    Active - Recruiting

  • McGill University Health Center

    Montréal, Quebec H4A 3J1
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.