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

Study Overview
=================
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.

Official Title
-----------------
Single Pre-Operative Radiation Therapy - With Delayed Surgery (SPORT-DS) for Low Risk Breast Cancer: A Phase 1 Study

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Radiation: Single Pre-Operative Radiation Therapy - with Delayed Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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 Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment Estrogen receptor status (ER) not known Currently pregnant or lactating Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol Geographic inaccessibility for follow-up Lack of preoperative staging with breast and axillary ultrasound Inability to adequately plan the patient for the experimental technique

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Pre-Operative Radiation Therapy with Delayed Surgery<br>Single Pre-Operative Radiation Therapy with Delayed Surgery | Radiation: Single Pre-Operative Radiation Therapy - with Delayed Surgery<br>* Single Pre-Operative Radiation Therapy - with Delayed Surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of pathological complete response |  | at the time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of radiation toxicity |  | in the 2 years after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiation therapy