Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer

NCT ID: NCT01717261

Last Updated: 2023-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2023-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single Pre-Operative Radiation Therapy

Group Type EXPERIMENTAL

Single Pre-Operative Radiation Therapy

Intervention Type RADIATION

Dose escalation: 3 patients will receive 15 Gy in a single fraction. The following 3 patients will receive 18 Gy. The final 4 patients will receive 20 Gy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Single Pre-Operative Radiation Therapy

Dose escalation: 3 patients will receive 15 Gy in a single fraction. The following 3 patients will receive 18 Gy. The final 4 patients will receive 20 Gy.

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female aged 60 years or older.
* Invasive ductal carcinoma.
* Unifocal disease.
* Tumors less than 2cm.
* No clinical evidence of nodal disease.
* Estrogen receptor status (ER) positive.
* Her2 negative.

Exclusion Criteria

* Age less than 60 years.
* BRCA 1 and/or BRCA 2 mutation.
* Tumour histology limited to lobular carcinoma only.
* Neoadjuvant hormonal manipulation or chemotherapy.
* More than one primary tumour in different quadrants of the same breast.
* Inability to view tumor on imaging.
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Yassa

Radiation Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Yassa, MD

Role: STUDY_CHAIR

Maisonneuve-Rosemon Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12030

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Concurrent Boost Radiotherapy
NCT00981864 COMPLETED PHASE2