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Stereotactic Body Radiation Therapy for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03585621
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : May 9, 2022
Sponsor:
Information provided by (Responsible Party):
Danny Vesprini, MD, MSc, FRCPC, Toronto Sunnybrook Regional Cancer Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: SBRT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential dose escalation design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I-II Study of Stereotactic Body Radiation Therapy for Breast Cancer (SBRT Breast)
Actual Study Start Date : July 17, 2018
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : July 17, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: SBRT to the Primary Breast Tumour
SBRT to the breast using 4 sequentially escalating dose levels from 9Gy to 12 Gy.
 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.
Other Name: SABR


Outcome Measures
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Primary Outcome Measures :
  1. Acute toxicity [ Time Frame: 12 weeks post treatment ]
    Incidence of side effects /toxicity associated with SBRT to the breast, during and in the three months following treatment using CTCAE v4.0


Secondary Outcome Measures :
  1. Breast Symptom Scores [ Time Frame: 2 years post treatment ]
    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. Patient Reported Quality of Life [ Time Frame: 2 years post treatment ]
    Patient reported quality of life measured using the combined EORTC QLQ-C30 and QLQ-BR23 questionnaires

  3. Patient Reported Quality of Life [ Time Frame: 2 years post treatment ]
    Patient reported quality of life measured using the VES13 questionnaire.

  4. Patient Reported Pain Level [ Time Frame: 2 years post treatment ]
    Patient reported pain levels measured on a scale from 1 (no pain) to 10 (maximum pain tolerable) using the Visual Analogue Scale for Pain

  5. Tumour Response Rate [ Time Frame: 2 years post treatment ]
    Measured on follow-up MRI or CT imaging using RECIST criteria


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585621


Contacts
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Contact: Danny Vesprini, MD, FRCPC 4164804806 Danny.Vesprini@sunnybrook.ca
Contact: Merrylee McGuffin, MSc, MRT(T) 4164806100 ext 85454 Merrylee.McGuffin@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Danny J Vesprini, MD, FRCPC    416-480-4806    danny.vesprini@sunnybrook.ca   
Contact: Merrylee M McGuffin, MSc, MRT(T)    416-480-6100 ext 85454    Merrylee.McGuffin@sunnybrook.ca   
Principal Investigator: Danny J Vesprini, MD, FRCPC         
Sub-Investigator: Claire McCann, PhD         
Sponsors and Collaborators
Toronto Sunnybrook Regional Cancer Centre
Investigators
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Principal Investigator: Danny Vesprini, MD, FRCPC Sunnybrook Health Sciences Centre, University of Toronto
More Information
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Responsible Party: Danny Vesprini, MD, MSc, FRCPC, Deputy Chief, Department of Radiation Oncology - Clinical Care, Toronto Sunnybrook Regional Cancer Centre
ClinicalTrials.gov Identifier: NCT03585621    
Other Study ID Numbers: 003-2017
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases