Stereotactic Body Radiation Therapy for Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase I-II Study of Stereotactic Body Radiation Therapy for Breast Cancer (SBRT Breast)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03585621
• Other study ID #: 003-2017
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2018
• Est. completion date: July 17, 2025

Study information

• Verified date: April 2024
• Source: Toronto Sunnybrook Regional Cancer Centre
• Contact: Danny Vesprini, MD, FRCPC
• Phone: 4164804806
• Email: Danny.Vesprini[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, single institution, phase I-II study of stereotactic body radiotherapy (SBRT) for unresected breast cancer. Twenty-four patients with advanced breast cancer who are not candidates for surgery (metastatic disease, unresectable, medically inoperable) or decline surgery will be enrolled in a prospective study using SBRT (4 fractions of radiation therapy over 12-15 days) as the primary treatment modality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 17, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology.

Unifocal tumour Previously assessed by a breast surgeon and medical oncologist, with no surgery being recommended at time of enrollment.

Primary breast and axillary surgery not recommended/performed due to any of the following:

• distant metastatic disease

• unresectable T4 disease and/or

• medically inoperable and/or

• patient declined breast surgery Stages T1-T4, N1-N2, M0-M1 disease Ability to attend radiation planning and therapy, able to attend for follow-up care Able to provide written informed consent.

Exclusion Criteria:

Received chemotherapy within 3 weeks prior to breast SBRT. (Concurrent endocrine therapy is permitted) Multifocal or multicentric tumours. Ipsilateral supraclavicular or infraclavicular nodal disease >= 1cm size that is at the level of or superior to the brachial plexus Unable to meet the brachial plexus dose constraints despite compromising coverage of target volumes - as per the discretion of the treating physician Treatment target volume estimated to occupy > 50% of the ipsilateral whole breast volume.

Locally recurrent breast cancer, with previous radiotherapy to the breast, or previous lumpectomy or mastectomy. Ipsilateral breast implant. Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g.

scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).

Women who are pregnant or lactating. Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• SBRT
Each radiation treatment plan will be customized to the patient and tumour in order to deliver highly conformal, conebeam CT guided SBRT radiotherapy in 4 fractions delivered over 2-4 weeks.

Locations

Country	Name	City	State
Canada	Sunnybrook Odette Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Toronto Sunnybrook Regional Cancer Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute toxicity	Incidence of side effects /toxicity associated with SBRT to the breast, during and in the three months following treatment using CTCAE v4.0	12 weeks post treatment
Secondary	Breast Symptom Scores	Patient reported breast symptom scores for bleeding, discharge and odour measured on a scale from 1 (no symptoms) to 10 (worst possible/continuous symptoms) using the Visual Analogue Scale tool	2 years post treatment
Secondary	Patient Reported Quality of Life	Patient reported quality of life measured using the combined EORTC QLQ-C30 and QLQ-BR23 questionnaires	2 years post treatment
Secondary	Patient Reported Quality of Life	Patient reported quality of life measured using the VES13 questionnaire.	2 years post treatment
Secondary	Patient Reported Pain Level	Patient reported pain levels measured on a scale from 1 (no pain) to 10 (maximum pain tolerable) using the Visual Analogue Scale for Pain	2 years post treatment
Secondary	Tumour Response Rate	Measured on follow-up MRI or CT imaging using RECIST criteria	2 years post treatment