EXamining PErsonalised Radiation Therapy for Low-risk Early Breast Cancer (EXPERT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02889874|
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : June 30, 2022
|Condition or disease||Intervention/treatment||Phase|
|Early Stage Breast Carcinoma||Radiation: Omission of radiation therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1167 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Phase III Trial of Adjuvant Radiation Therapy Versus Observation Following Breast Conserving Surgery and Endocrine Therapy in Patients With Molecularly Characterised Luminal A Early Breast Cancer|
|Actual Study Start Date :||August 21, 2017|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
No Intervention: A: Radiation Therapy & endocrine therapy
Patients randomized to Arm A will receive standard radiation therapy and adjuvant endocrine therapy (standard of care).
Experimental: B: No Radiation Therapy (ET only)
Patients randomized to Arm B will not receive radiation therapy (omission of radiation therapy) and receive adjuvant endocrine therapy only.
Radiation: Omission of radiation therapy
Omission of radiation therapy (adjuvant endocrine therapy only).
- Local recurrence rate after breast conserving surgery [ Time Frame: 10 years ]The time from randomisation to the date of local recurrence (LR) as a site of first recurrence.
- Local-regional recurrence-free interval (LRRFI) [ Time Frame: 10 years ]Time from randomisation to the date of local or regional recurrence as a site of first recurrence.
- Distant recurrence-free interval (DRFI) [ Time Frame: 10 years ]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.
- Disease free survival including DCIS (DFS-DCIS) [ Time Frame: 10 years ]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.
- Invasive disease free survival (iDFS) [ Time Frame: 10 years ]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.
- Recurrence-free interval [ Time Frame: 10 years ]Time from randomisation to the date of local, regional or distant recurrence as a site of first recurrence.
- Overall survival (OS) [ Time Frame: 10 years ]Time from randomisation to date of death from any cause.
- Salvage RT or mastectomy rate [ Time Frame: 10 years ]Time from randomisation to the receipt of salvage RT or mastectomy, individually and in combination (one or the other) as a composite endpoint.
- Adverse events for patients [ Time Frame: 5 years ]Adverse events during treatment (up to 5 years of endocrine therapy) assessed using NCI CTCAE v4.0.
- Assessment of the impact of endocrine therapy [ Time Frame: 5 years ]FACT-ES measure of endocrine symptoms.
- Quality of Life: Fear of recurrence [ Time Frame: 5 years ]Fear of Cancer Recurrence Inventory
- Quality of Life: Convenience of care [ Time Frame: 5 years ]Visual Analogue Scales (convenience and impact of treatment)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889874
|Contact: Heath Badger||+61 2 4925 email@example.com|
|Contact: Akiko Fong||+61 2 4925 firstname.lastname@example.org|
|Study Director:||Heath Badger||Breast Cancer Trials, Australia and New Zealand|
|Study Chair:||Boon H Chua, Prof||Prince of Wales Hospital|