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Radiation Therapy

SBRT for Breast Cancer

N/A

Recruiting

Led By Danny Vesprini, MD, FRCPC

Research Sponsored by Toronto Sunnybrook Regional Cancer Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post treatment

Awards & highlights

Study Summary

This trial will study if SBRT is an effective treatment for 24 patients with unresectable breast cancer.

Who is the study for?

This trial is for adults with advanced breast cancer who can't have surgery due to metastasis, inoperability, or personal choice. They must not have had chemotherapy within the last 3 weeks but can be on endocrine therapy. Participants need a confirmed diagnosis of invasive non-lobular breast carcinoma and must commit to attending all treatment sessions and follow-ups.Check my eligibility

What is being tested?

The study tests Stereotactic Body Radiation Therapy (SBRT) as a primary treatment for unresectable breast cancer. It involves giving patients four high-dose radiation treatments over approximately two weeks to see how effective it is against their cancer.See study design

What are the potential side effects?

Potential side effects of SBRT may include skin reactions, fatigue, pain at the site of treatment, swelling or firmness in the treated area, and rarely more serious complications like damage to nearby organs such as the heart or lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acute toxicity

Secondary outcome measures

Breast Symptom Scores

Patient Reported Pain Level

Patient Reported Quality of Life

+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Pneumothorax

Malnutrition, Hypercalcemia and Weakness

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: SBRT to the Primary Breast TumourExperimental Treatment1 Intervention

SBRT to the breast using 4 sequentially escalating dose levels from 9Gy to 12 Gy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SBRT

2014

Completed Phase 2

~1060

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Toronto Sunnybrook Regional Cancer CentreLead Sponsor

9 Previous Clinical Trials

929 Total Patients Enrolled

1 Trials studying Breast Cancer

30 Patients Enrolled for Breast Cancer

Danny Vesprini, MD, FRCPCPrincipal InvestigatorSunnybrook Health Sciences Centre, University of Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for prospective participants to join this research endeavor?

"Affirmative. Clinicaltrials.gov records indicate that this medical trial is actively seeking participants, with the first posting on July 17th 2018 and an update dated to May 5th 2022. 24 individuals are being sought from one research centre for recruitment into the study."

Answered by AI

How many participants are being recruited for this research endeavor?

"Affirmative. Clinicaltrials.gov indicates that this research study is recruiting patients, which began on July 17th 2018 and was last updated on May 5th 2022. 24 participants are being sought from one clinical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Body Radiation Therapy for Breast Cancer

Danny Vesprini, MD, MSc, FRCPC 2018. "Stereotactic Body Radiation Therapy for Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03585621.