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Radiation
Partial vs Whole Breast Irradiation for Early-Stage Breast Cancer
Phase 3
Recruiting
Led By Timothy Whelan, M.D.
Research Sponsored by Ontario Clinical Oncology Group (OCOG)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection
Treated by BCS with microscopically clear resection margins ≥ 1mm for invasive and non-invasive disease or no residual disease on re-excision
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks post-radiation treatment, then at 3 and 5 years post-randomization.
Awards & highlights
Study Summary
This trial is testing whether a new, once-a-day radiation treatment is as effective as the current standard treatment for early-stage breast cancer, and whether it causes less cosmetic damage.
Who is the study for?
This trial is for women over 50 with node-negative breast cancer that's 3cm or smaller, treated by surgery with clear margins. They must not be pregnant, lactating, BRCA positive, have a tumor larger than 3cm, multiple primary tumors in different quadrants of the same breast, a history of other cancers within the last five years (except certain skin cancers), or previous/synchronous contralateral breast cancer.Check my eligibility
What is being tested?
The study compares Partial Breast Irradiation (PBI) to Whole Breast Irradiation (WBI) in patients after breast-conserving surgery. Both treatments are given once daily over one week. The goal is to see if PBI is as effective as WBI at preventing local recurrence and maintaining good cosmetic results three years post-treatment.See study design
What are the potential side effects?
Potential side effects from both PBI and WBI may include skin changes like redness and irritation, fatigue during treatment weeks, potential discomfort in the treated area, and rare risks of more serious complications such as tissue damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My underarm lymph nodes do not have cancer, confirmed by biopsy or surgery.
Select...
My breast cancer surgery removed all visible cancer with clear margins of at least 1mm.
Select...
I am a woman newly diagnosed with invasive breast cancer without spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks post-radiation treatment, then at 3 and 5 years post-randomization.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks post-radiation treatment, then at 3 and 5 years post-randomization.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Local Recurrence
Patient Assessment Cosmesis at 3 years
Secondary outcome measures
Disease Free Survival (DFS)
Distant Disease Free Survival (DDSF)
Nurse/Clinical Research Associate assessed cosmesis at 3 and 5 years.
+4 moreSide effects data
From 2017 Phase 1 & 2 trial • 100 Patients • NCT003255986%
Erythema
6%
Hyperpigmentation
6%
Fibrosis/induration
4%
Breast pain
4%
Fatigue
4%
Edema - breast
2%
Edema - Nipple/Areolar
2%
Dyspnea
2%
Shoulder pain
2%
Chest wall pain
2%
Breast edema
2%
Fever
2%
Rigors/chills
2%
Pelvic pain
2%
Chest pain
2%
Infection (mastitis)
2%
Costochondritis
2%
Throat pain
2%
Dysphagia
2%
Rash/desquamation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1 (36 Gy) Acute Toxicities
Cohort 1 (36 Gy) Late Toxicities
Cohort 2 (40 Gy) Acute Toxicities
Cohort 2 (40 Gy) Late Toxicities
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Partial Breast Irradiation (PBI)Experimental Treatment1 Intervention
26 Gy in 5 fractions to the tumour bed with a margin of normal tissue
Group II: Whole Breast Irradiation (WBI)Active Control1 Intervention
26 Gy in 5 fractions to the whole breast
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Partial Breast Irradiation (PBI)
2006
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Ontario Clinical Oncology Group (OCOG)Lead Sponsor
62 Previous Clinical Trials
40,975 Total Patients Enrolled
16 Trials studying Breast Cancer
9,118 Patients Enrolled for Breast Cancer
Timothy Whelan, M.D.Principal InvestigatorJuravinski Cancer Centre and McMaster University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer other than non-melanoma skin cancer or in-situ carcinoma in the last 5 years.My tumor bed cannot be seen on a CT scan.My underarm lymph nodes do not have cancer, confirmed by biopsy or surgery.My tumor is larger than 3cm in size.I have tested positive for BRCA 1 or BRCA 2.I am under 50 years old.My breast cancer surgery removed all visible cancer with clear margins of at least 1mm.I have more than one tumor in different areas of the same breast.I cannot participate in the experimental technique planned for the study.My breast cancer is lobular carcinoma.I am a woman newly diagnosed with invasive breast cancer without spread.I have or had cancer in my other breast but not invasive cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Partial Breast Irradiation (PBI)
- Group 2: Whole Breast Irradiation (WBI)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the goal of this experiment?
"The aim of this research, which will be observed for 5 years after patients are randomly assigned to a treatment group, is to assess Patient Cosmesis at 3 years. Other objectives include measuring Distant Disease Free Survival (DDSF), Disease Free Survival (DFS), and Overall Survival."
Answered by AI
Are researchers looking for test subjects who are over 20 years old?
"Those wishing to enroll in this clinical trial must be aged between 50 and 120 years old, as stipulated by the inclusion criteria."
Answered by AI
Am I an eligible candidate for this research project?
"Eligibility for this study includes having had radiotherapy and being between 50-120 years old. Around 910 individuals are needed for the research."
Answered by AI
Does Partial Breast Irradiation (PBI) have any harmful side effects?
"PBI has received a score of 3 from our team at Power. This is because PBI is in Phase 3, meaning that there are data to support its efficacy and multiple rounds of safety data."
Answered by AI
Are we still looking for test subjects for this trial?
"The clinical trial in question was posted on October 1st, 2022 and was last updated September 19th, 2022. According to the website, this study is no longer recruiting participants; however, there are 2428 other trials that remain active."
Answered by AI
Are there several hospitals testing this treatment in North America?
"So far, this clinical trial has recruited patients from 35 locations, some of which include BCCA-Vancouver Island Cancer Centre in Victoria, London Regional Cancer Centre in London, and Royal Victoria Hospital in Barrie."
Answered by AI
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