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EXamining PErsonalised Radiation Therapy for Low-risk Early Breast Cancer
This is a randomised, phase III, non-inferiority trial evaluating radiation therapy versus observation following breast conserving surgery and planned endocrine therapy in patients with stage I breast cancer of luminal A subtype defined using the Prosigna (PAM50) Assay.
Study details:
Radiation therapy (RT) after breast conserving surgery to improve local control and survival is the current standard of care for patients with early breast cancer. However, breast cancer is a heterogeneous disease, and the absolute benefit of RT in individual patients varies substantially. Thus, a pressing priority in contemporary breast cancer management is to tailor RT utilisation to the individual recurrence risks by identifying patients who are unlikely to benefit from RT, thereby avoiding the morbidity and costs of over-treatment.
It is recognised that selected patients with early breast cancer are unlikely to derive benefits from RT after breast conserving surgery. However, randomised trials have not consistently identified patients who may safely omit RT using conventional clinical-pathologic characteristics. Breast cancer intrinsic subtypes distinguished by gene expression profiling are shown to be associated with distinct clinical outcomes.
There is substantial evidence supporting the clinical validity of multigene assays including the PAM50-based Prosigna Assay that identifies intrinsic subtypes and generates a Risk of Recurrence score (ROR) to quantify individual risks of distant relapse. Multigene assays are increasingly integrated into clinical practice to inform chemotherapy decision, highlighting their substantial practice changing potential in personalising the use of RT for early breast cancer. A recent analysis of archived tumour specimens of 1,308 patients with early breast cancer has shown significant associations between local recurrence risk and the PAM50-defined intrinsic subtypes and ROR score.
EXPERT presents a unique opportunity of clinical and public health importance to optimise personalised local therapy for early breast cancer through precise, individualised quantification of local recurrence risk to identify low-risk patients for whom RT after breast conserving surgery may be safely omitted.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 50 and older
Healthy volunteers accepted : No
Gender eligible for study: Female
Things to know
Study dates
Study start: 2017-08-21
Primary completion: 2025-10-01
Study completion finish: 2026-04-01
Study type
TREATMENT
Phase
NA
Trial ID
NCT02889874
Intervention or treatment
RADIATION: Omission of radiation therapy
Conditions
- • Early Stage Breast Carcinoma
Find a site
Closest Location:
St Vincent's Hospital, Sydney
Research sites nearby
Select from list below to view details:
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, Australia
Gosford Hospital
Gosford, New South Wales, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
NO_INTERVENTION: A: Radiation Therapy & endocrine therapy
| Not specified |
EXPERIMENTAL: B: No Radiation Therapy (ET only)
| RADIATION: Omission of radiation therapy
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Local recurrence rate after breast conserving surgery | The time from randomisation to the date of local recurrence (LR) as a site of first recurrence. | 10 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Local-regional recurrence-free interval (LRRFI) | Time from randomisation to the date of local or regional recurrence as a site of first recurrence. | 10 years |
Distant recurrence-free interval (DRFI) | Time from randomisation to the date of distant recurrence, regardless of occurrence of any intervening local or regional recurrence, contralateral breast cancer or second (non-breast) primary invasive cancer. | 10 years |
Disease free survival including DCIS (DFS-DCIS) | Time from randomisation to date of first evidence of local (invasive breast carcinoma or DCIS), regional or distanct recurrence; contralateral breast cancer (invasive breast carcinoma or DCIS); second (non-breast) primary invasive cancer; or death. | 10 years |
Invasive disease free survival (iDFS) | Time from randomisation to date of first evidence of local (invasive breast carcinoma), regional or distanct recurrence; contralateral breast cancer (invasive breast carcinoma); second (non-breast) primary invasive cancer; or death. | 10 years |
Recurrence-free interval | Time from randomisation to the date of local, regional or distant recurrence as a site of first recurrence. | 10 years |
Overall survival (OS) | Time from randomisation to date of death from any cause. | 10 years |
Salvage RT or mastectomy rate | Time from randomisation to the receipt of salvage RT or mastectomy, individually and in combination (one or the other) as a composite endpoint. | 10 years |
Adverse events for patients | Adverse events during treatment (up to 5 years of endocrine therapy) assessed using NCI CTCAE v4.0. | 5 years |
Assessment of the impact of endocrine therapy | FACT-ES measure of endocrine symptoms. | 5 years |
Frequently Asked Questions
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