Recruiting

Radiation Therapy

Sponsor:

Maisonneuve-Rosemont Hospital

Code:

NCT05217966

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Radiation: Single Pre-Operative Radiation Therapy

Study Details

Brief summary:

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

Conditions

Breast Cancer

Study ID

NCT05217966

Start date

Oct 8, 2021

Status verified date

Nov, 2024

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

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/hormone replacement 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 from treatment start.
6. Tumors less than or equal to 2cm clinically on physical exam, as well as on breast ultrasound.
7. No clinical evidence of nodal disease (i.e. cN0), on physical examination done ≤ 12 weeks 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 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 lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
18. Estrogen receptor status (ER) not known.
19. Currently pregnant or lactating.
20. Psychiatric or addictive disorders which would preclude obtaining informed consent or 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

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Preoperative radiotherapy for early breast cancer

Radiation: Single Pre-Operative Radiation Therapy

Interventions

Radiation: Single Pre-Operative Radiation Therapy

Ablative preoperative partial breast radiation therapy

Primary outcome measure

  • Incidence of pathological complete response [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

Maisonneuve-Rosemont Hospital

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Michael Yassa, MD

514-252-3425

Principal Investigator:

Michael Yassa, MD

McGill University Health Center

Recruiting

Montréal, Quebec, Canada, H4A 3J1

Contacts

Tarek Hijal, MD

(514) 934-1934

Principal Investigator:

Tarek Hijal, MD

More Information

Sponsor

Maisonneuve-Rosemont Hospital

Last update posted

Nov 19, 2024

Last verified

Nov, 2024

Keywords

  • ablative radiotherapy
  • preoperative radiotherapy
  • neoadjuvant radiotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maisonneuve-Rosemont Hospital on 2024-11-19.