Early Stage Breast CarcinomaEXPERTNCT02889874
EXamining PErsonalised Radiation Therapy for Low-risk Early Breast Cancer
A study testing Omission of radiation therapy in people with Early Stage Breast Carcinoma, run by Breast Cancer Trials, Australia and New Zealand at 68 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Early Stage Breast Carcinoma
- What is being tested?
- Omission of radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,167 participants
- Where
- 68 sitesin 9 countries
- Study dates
- 21 Aug 2017to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥ 50 years of any menopausal status.
- Primary tumour characteristics as assessed by conventional histopathology:
- Unifocal histologically confirmed invasive breast carcinoma
- Maximum microscopic size ≤2 cm
- Grade 1 or 2 histology
- ER and PR positive in ≥10% of tumour cells in either the biopsy or breast conserving surgical specimen
Show all 17Show fewer
- HER2 negative on IHC (score 0 or 1+) or in situ hybridisation (ERBB2-amplification Ratio ERBB2/centromeres <2.0 or mean gene copy number <6). Equivocal IHC score (2+) must be assessed by ISH.
- Primary tumour must be resected by breast conserving surgery with microscopically negative margins for invasive carcinoma and any associated ductal carcinoma in situ (no cancer cells adjacent to any inked edge/surface of specimen) or re-excision showing no residual disease.
- Histologically confirmed negative nodal status determined by sentinel node biopsy or axillary dissection. Patients with pN0 (i+) disease are eligible for study participation (malignant cells ≤0.2 mm in regional lymph node(s) detected by hematoxylin-eosin (H\&E) stain or IHC, including isolated tumour cells).
- No evidence of distant metastasis.
- Eligible for and willing to have adjuvant endocrine therapy.
- ECOG performance status 0-2.
- Availability of FFPE tumour block for Prosigna (PAM50) Assay.
- For randomization to the study, patients must fulfill all of the following criteria:
- 1. Primary tumour characteristics as assessed by Prosigna (PAM50) Assay:
- Luminal A intrinsic subtype
- ROR score ≤60
Who cannot join
- Any one of the following is regarded as a criterion for exclusion from the study:
- Primary tumour characteristics:
- Presence of multifocal or multicentric invasive carcinoma or ductal carcinoma in situ;
- Evidence of clinical or pathologic T4 disease (extension to the chest wall, oedema or ulceration of skin, satellite skin nodules, inflammatory carcinoma);
- The invasive component of the primary tumour is present as micro-invasion only;
- Grade 3 histology;
Show all 25Show fewer
- Presence of lymphovascular invasion
- Contra-indication or unwillingness to have adjuvant endocrine therapy.
- Planned to receive adjuvant chemotherapy or biologic therapy after breast cancer surgery, i.e. any systemic therapy other than endocrine therapy is not permitted. Any therapy unrelated to cancer is permitted at the discretion of investigators.
- Treated with neoadjuvant endocrine therapy, chemotherapy or biologic therapy prior to breast cancer surgery.
- Prior breast or thoracic RT for any condition.
- Pre-operative breast imaging evidence of disease aside from the primary carcinoma resected by breast conserving surgery.
- Concurrent invasive breast carcinoma or ductal carcinoma in situ (synchronous or metachronous).
- Prior diagnosis of invasive breast carcinoma or ductal carcinoma in situ in either breast irrespective of disease free interval.
- A diagnosis of non-breast malignancy <5 years prior to randomisation with the following exceptions:
- Patients who are diagnosed with carcinoma in situ of cervix, endometrium or colon; melanoma in situ; and basal or squamous cell carcinoma of the skin at any time prior to randomisation are not excluded from study participation.
- Patients who are diagnosed with other non-breast malignancy ≥5 years prior to randomisation and without evidence of disease recurrence are not excluded from study participation.
- Significant comorbidity precluding definitive RT for breast cancer (e.g. cardiovascular or pulmonary disease, scleroderma, systemic lupus erythematosus).
- Life expectancy <10 years.
- Documented mutation of BRCA1, BRCA2 or TP53, or at high genetic risk of breast cancer.
- Pregnant or lactating patients.
- Inability to be registered to the study ≤8 weeks after the last surgical procedure for breast cancer.
- Inability to commence RT (if randomised to receive RT) no later than 12 weeks from the last surgical procedure for breast cancer.
- Inability to provide written informed consent.
- Psychiatric, addictive, or any disorder that precludes compliance with protocol requirements.
Trial locations and contacts
68 sites in 9 countries.
68 sites in 9 countries
Australia32 sites
Genesis Cancer Care Wesley
Auchenflower, Queensland, 4066
Ballarat Austin Radiation Oncology Centre
Ballarat, Victoria, 3353
Peter MacCallum Cancer Centre - Bendigo
Bendigo, Victoria, 3550
Peter MacCallum Cancer Centre - Moorabin
Bentleigh East, Victoria, 3165
Box Hill Hospital
Box Hill, Victoria, 3128
Cancer Care Service - Bundaberg
Bundaberg, Queensland, 4670
Cancer Care Service - Hervey Bay
Bundaberg, Queensland, 4670
Macarthur Cancer Therapy Centre
Campbelltown, New South Wales, 2560
The Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
The Canberra Hospital
Canberra, Australian Capital Territory, 2605
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, 2010
Icon Cancer Centre Richmond
East Melbourne, Victoria, 3002
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
GenesisCare Radiation Oncology Centre Frankston
Frankston, Victoria, 3199
Genesis Cancer Care Newcastle
Gateshead, New South Wales, 2290
University Hospital Geelong
Geelong, Victoria, 3220
Gosford Hospital
Gosford, New South Wales, 2250
Austin Hospital
Heidelberg, Victoria, 3084
GenesisCare Tennyson
Kurralta Park, South Australia, 5037
Liverpool Hospital
Liverpool, New South Wales, 1871
Peter MacCallum Cancer Centre
Melbourne, Victoria, 8006
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Calvary Mater Newcastle
Newcastle, New South Wales, 2298
Mater Hospital Sydney
North Sydney, New South Wales, 2060
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444
Prince of Wales Hospital
Randwick, New South Wales, 2031
Ringwood Radiation Oncology Centre
Ringwood East, Victoria, 3135
Tamworth Rural Referral Hospital
Tamworth, New South Wales, 2340
Latrobe Regional Hospital
Traralgon, Victoria, 3844
Westmead Hospital
Westmead, New South Wales, 2145
Wollongong Hospital
Wollongong, New South Wales, 2500
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Taiwan10 sites
Changhua Christian Hospital
Changhua, 500
Kaohsiung Medical University Hospital
Kaohsiung City
Taichung Veterans General Hospital
Taichung, 407204
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100
Mackay Memorial Hospital
Taipei, 10449
Taipei Veterans General Hospital
Taipei, 11217
Tri-Service General Hospital
Taipei, 114
Taipei Medical University Hospital
Taipei
Chang-Gung Memorial Hospital
Taoyuan, 10449
Chile5 sites
Centro Oncologico del Norte
Antofagasta
Hospital Sotero del Rio
Puente Alto
Hospital Barros Luco Trudeau
San Miguel
Hospital Luis Tisne Brousse
Santiago, Santiago Metropolitan
Instituto Nacional del Cancer
Santiago, 1010
Spain5 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona
Hospital Universitari Arnoa de Vilanova de Lleida
Lleida
Hospital Universitario Virgen de la Macarena
Seville
Hospital Universitario Virgen del Rocio
Seville
Switzerland5 sites
Hirslanden Clinique des Grangettes
Chêne-Bougeries, 1224
Fondazione Oncologia Lago Maggiore
Locarno, 6600
Kantonsspital Winterthur
Winterthur, 8400
Brust-Zentrum AG Zurich
Zurich, 8008
Universitatsspital Zurich
Zurich, 8091
New Zealand4 sites
Christchurch Hospital
Christchurch, 8011
Waikato Hospital
Hamilton, 3240
Palmerston North Hospital
Palmerston North, 4414
Wellington Hospital
Wellington, 6021
Argentina3 sites
Sanatorio Britanico Rosariio
Rosario, Santa Fe Province, S2000
Instituto de Oncologia de Rosario
Santa Fe
Clinica Viedma
Sarmiento, R8500ACE
Ireland2 sites
St Luke's Radiation Oncology Network
Dublin
University Hospital Galway
Galway
Italy2 sites
ASST Ospedale A. Manzoni UOS Oncologia
Lecco
Istituto Europeo di Oncologia
Milan
About this study
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
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.
Read the detailed description
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.
- Conditions
- Early Stage Breast Carcinoma
- Being tested
- Omission of radiation therapy
- Keywords
- Radiation therapy, omission, non-inferiority, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omission of radiation therapyRadiation
Omission of radiation therapy (adjuvant endocrine therapy only).
| Study group | Role | What they receive |
|---|---|---|
| A: Radiation Therapy & endocrine therapy | No intervention | Patients randomized to Arm A will receive standard radiation therapy and adjuvant endocrine therapy (standard of care). |
| B: No Radiation Therapy (ET only) | Experimental | Patients randomized to Arm B will not receive radiation therapy (omission of radiation therapy) and receive adjuvant endocrine therapy only. Receives: Radiation: Omission of radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence rate after breast conserving surgery
The time from randomisation to the date of local recurrence (LR) as a site of first recurrence.
Measured: 10 years
Secondary outcomes (9)
Local-regional recurrence-free interval (LRRFI)
Time from randomisation to the date of local or regional recurrence as a site of first recurrence.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 years
Recurrence-free interval
Time from randomisation to the date of local, regional or distant recurrence as a site of first recurrence.
Measured: 10 years
Overall survival (OS)
Time from randomisation to date of death from any cause.
Measured: 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.
Measured: 10 years
Adverse events for patients
Adverse events during treatment (up to 5 years of endocrine therapy) assessed using NCI CTCAE v4.0.
Measured: 5 years
Assessment of the impact of endocrine therapy
FACT-ES measure of endocrine symptoms.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start21 Aug 2017
- Primary completionSep 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Breast Cancer Trials, Australia and New Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- Breast International Group, ETOP IBCSG Partners Foundation
- Responsible party
- Sponsor
- Investigators
- Heath Badger, Study director, Breast Cancer Trials, Australia and New ZealandBoon H Chua, Prof, Study chair, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889874
- Sponsor's protocol ID
- ANZ1601/BIG 16-02
- Other IDs
- 2016-003527-33, 2016
- Acronym
- EXPERT
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2016
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised Individual Patient Data (IPD) collected during the trial as per BCT Data Sharing Guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02889874
- Acronym / sponsor ID
- EXPERT / ANZ1601/BIG 16-02
- Conditions
- Early Stage Breast Carcinoma
- Keywords
- Radiation therapy, omission, non-inferiority, breast cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,167 participants (estimated)
- Lead sponsor
- Breast Cancer Trials, Australia and New ZealandUniversity, hospital or other
- Collaborators
- Breast International Group, ETOP IBCSG Partners Foundation
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Radiation Therapy & endocrine therapy | No intervention | –Patients randomized to Arm A will receive standard radiation therapy and adjuvant endocrine therapy (standard of care). |
| B: No Radiation Therapy (ET only) | Experimental | Radiation: Omission of radiation therapyPatients randomized to Arm B will not receive radiation therapy (omission of radiation therapy) and receive adjuvant endocrine therapy only. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Female patients aged ≥ 50 years of any menopausal status.
- Primary tumour characteristics as assessed by conventional histopathology:
- Primary tumour must be resected by breast conserving surgery with microscopically negative margins for invasive carcinoma and any associated ductal carcinoma in situ (no cancer cells adjacent to any inked edge/surface of specimen) or re-excision showing no residual disease.
- Histologically confirmed negative nodal status determined by sentinel node biopsy or axillary dissection. Patients with pN0 (i+) disease are eligible for study participation (malignant cells ≤0.2 mm in regional lymph node(s) detected by hematoxylin-eosin (H\&E) stain or IHC, including isolated tumour cells).
- No evidence of distant metastasis.
Key exclusion criteria (25 listed)
- Primary tumour characteristics:
- Contra-indication or unwillingness to have adjuvant endocrine therapy.
- Planned to receive adjuvant chemotherapy or biologic therapy after breast cancer surgery, i.e. any systemic therapy other than endocrine therapy is not permitted. Any therapy unrelated to cancer is permitted at the discretion of investigators.
- Treated with neoadjuvant endocrine therapy, chemotherapy or biologic therapy prior to breast cancer surgery.
- Prior breast or thoracic RT for any condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omission of radiation therapyOmission of radiation therapy (adjuvant endocrine therapy only). | Radiation | B: No Radiation Therapy (ET only) |
Primary outcome
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.
9 secondary outcomes
Local-regional recurrence-free interval (LRRFI)
Time frame: 10 years
Distant recurrence-free interval (DRFI)
Time frame: 10 years
Disease free survival including DCIS (DFS-DCIS)
Time frame: 10 years
Invasive disease free survival (iDFS)
Time frame: 10 years
Recurrence-free interval
Time frame: 10 years
Overall survival (OS)
Time frame: 10 years
Salvage RT or mastectomy rate
Time frame: 10 years
Adverse events for patients
Time frame: 5 years
Assessment of the impact of endocrine therapy
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Breast Cancer Trials (formerly Australia \& New Zealand Breast Cancer Trials GroupLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymised Individual Patient Data (IPD) collected during the trial as per BCT Data Sharing Guidelines.
Related trials for Early Stage Breast Carcinoma
RecruitingObservational study
A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
Early-stage HER2+ Breast Cancer
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 2
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Breast Cancer Invasive, Early-stage Breast Cancer
Active, not recruitingObservational study
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Breast Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heath Badger study director
Breast Cancer Trials, Australia and New Zealand
Boon H Chua, Prof study chair
Prince of Wales Hospital, Shatin, Hong Kong
68 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omission of radiation therapy in people with Early Stage Breast Carcinoma, run by Breast Cancer Trials, Australia and New Zealand at 68 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in Australia, Taiwan, Chile, Spain, Switzerland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence rate after breast conserving surgery (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.