Clinical trial NCT03585621: Stereotactic Body Radiation Therapy for Breast Cancer
Official title: A Phase I-II Study of Stereotactic Body Radiation Therapy for Breast Cancer (SBRT Breast)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Toronto Sunnybrook Regional Cancer Centre
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Sequential dose escalation design
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Acute toxicity
timeFrame: 12 weeks post treatment
Secondary outcomes:
measure: Breast Symptom Scores
timeFrame: 2 years post treatment
measure: Patient Reported Quality of Life
timeFrame: 2 years post treatment
measure: Patient Reported Quality of Life
timeFrame: 2 years post treatment
measure: Patient Reported Pain Level
timeFrame: 2 years post treatment
measure: Tumour Response Rate
timeFrame: 2 years post treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre, University of Toronto
name: Danny Vesprini, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: