NCT01717261

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

6.3 years

First QC Date

October 22, 2012

Last Update Submit

October 30, 2023

Conditions

Breast Cancer

Keywords

breast cancerearly breast cancerpartial breast irradiationpreoperative radiation

Outcome Measures

Primary Outcomes (1)

  • Acute toxicity

    Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.

    6 months

Secondary Outcomes (2)

  • Chronic toxicity

    2 years

  • Cosmetic outcome

    5 years

Other Outcomes (1)

  • Ipsilateral breast cancer recurrence

    5 years

Study Arms (1)

Single Pre-Operative Radiation Therapy

EXPERIMENTAL
Radiation: Single Pre-Operative Radiation Therapy

Interventions

Single Pre-Operative Radiation TherapyRADIATION

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.

Single Pre-Operative Radiation Therapy

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael Yassa, MD

    Maisonneuve-Rosemon Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

October 22, 2012

First Posted

October 30, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2018

Study Completion

October 1, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations

CA(1)