Single Pre-Operative Radiation Therapy - With Delayed Surgery for Low Risk Breast Cancer

NCT03917498 | Active Not Recruiting

• 1 other identifier: SPORT-DS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To study a single dose of preoperative partial radiotherapy to a low-risk breast tumour. The radiotherapy will be goven 3 months before surgery.

Conditions

Breast Cancer

Keywords

radiation therapy

Outcome Measures

Primary Outcomes (1)

• rate of pathological complete response

  at the time of surgery

Secondary Outcomes (1)

• incidence of radiation toxicity

  in the 2 years after treatment

Study Arms (1)

Single Pre-Operative Radiation Therapy with Delayed Surgery

EXPERIMENTAL

Single Pre-Operative Radiation Therapy with Delayed Surgery

Radiation: Single Pre-Operative Radiation Therapy - with Delayed Surgery

Interventions

Single Pre-Operative Radiation Therapy - with Delayed Surgery RADIATION

Single Pre-Operative Radiation Therapy - with Delayed Surgery

Single Pre-Operative Radiation Therapy with Delayed Surgery

Eligibility Criteria

• Age: 65 Years+
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Female aged 65 years or older
• 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 done ≤ 12 weeks from treatment start
• Tumors less than 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
• Her2 negative on biopsy
• Grade 1 or 2 on biopsy
• Planned surgery is a partial mastectomy with sentinel lymph node biopsy
• Localisation markers placed before treatment

You may not qualify if:

• Age less than 65 years
• 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 history of cancer (Patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial)
• 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

Sponsors & Collaborators

• Michael Yassa: lead

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (1)

• Lavigne D, Hijal T, Vavassis P, Guilbert MC, Sideris L, Dube P, Gervais MK, Leblanc G, Dufresne MP, Nguyen D, Tiberi D, Mahmoud D, Yassa M. Single preoperative radiation therapy with delayed surgery for low-risk breast cancer: Oncologic outcome, toxicity and cosmesis of the SPORT-DS phase I trial. Radiother Oncol. 2024 Nov;200:110515. doi: 10.1016/j.radonc.2024.110515. Epub 2024 Aug 30.

  PMID: 39218041 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 17, 2019
• Study Start: April 1, 2018
• Primary Completion: February 28, 2020
• Study Completion: December 31, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

CA (1)