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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
Must not have
History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma
Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks post-radiation treatment, then at 3 and 5 years post-randomization.
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.
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.
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 below
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't had cancer other than non-melanoma skin cancer or in-situ carcinoma in the last 5 years.
Select...
My tumor bed cannot be seen on a CT scan.
Select...
My tumor is larger than 3cm in size.
Select...
I have tested positive for BRCA 1 or BRCA 2.
Select...
I am under 50 years old.
Select...
My breast cancer is lobular carcinoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks post-radiation treatment, then at 3 and 5 years post-randomization.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks post-radiation treatment, then at 3 and 5 years post-randomization. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Local Recurrence
Patient Assessment Cosmesis at 3 years
Secondary study objectives
Disease Free Survival (DFS)
Distant Disease Free Survival (DDSF)
Nurse/Clinical Research Associate assessed cosmesis at 3 and 5 years.
+4 more

Side effects data

From 2017 Phase 1 & 2 trial • 100 Patients • NCT00325598
6%
Erythema
6%
Hyperpigmentation
6%
Fibrosis/induration
4%
Breast pain
4%
Fatigue
4%
Edema - breast
2%
Dyspnea
2%
Edema - Nipple/Areolar
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

Awards & Highlights

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.

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
64 Previous Clinical Trials
41,177 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

Partial Breast Irradiation (PBI) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05417516 — Phase 3
Breast Cancer Research Study Groups: Partial Breast Irradiation (PBI), Whole Breast Irradiation (WBI)
Breast Cancer Clinical Trial 2023: Partial Breast Irradiation (PBI) Highlights & Side Effects. Trial Name: NCT05417516 — Phase 3
Partial Breast Irradiation (PBI) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05417516 — Phase 3
~607 spots leftby Nov 2029
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