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

NCT05217966 | Recruiting DMC

• 1 other identifier: MP-12-2021-2565
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Breast Cancer

Keywords

ablative radiotherapy; preoperative radiotherapy; neoadjuvant radiotherapy

Outcome Measures

Primary Outcomes (1)

• Incidence of pathological complete response

  12 months

Secondary Outcomes (1)

• Incidence of grade 3 or greater radiation toxicity

  0-5 years

Study Arms (1)

Preoperative radiotherapy for early breast cancer

EXPERIMENTAL

Radiation: Single Pre-Operative Radiation Therapy

Radiation: Radiation: Single Pre-Operative Radiation Therapy

Interventions

Radiation: Single Pre-Operative Radiation Therapy RADIATION

Ablative preoperative partial breast radiation therapy

Preoperative radiotherapy for early breast cancer

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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+).
• 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.

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (2)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Michael Yassa

CONTACT

514-252-3425; michael.yassa.med@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 1, 2022
• Study Start: October 8, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

CA (2)