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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02889874


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT02889874
Ethics application status
Date submitted
25/08/2016
Date registered
7/09/2016

Titles & IDs
Public title
EXamining PErsonalised Radiation Therapy for Low-risk Early Breast Cancer
Scientific 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
Secondary ID [1] 0 0
2016-003527-33
Secondary ID [2] 0 0
ANZ1601/BIG 16-02
Universal Trial Number (UTN)
Trial acronym
EXPERT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Stage Breast Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Omission of radiation therapy

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.


Treatment: Other: Omission of radiation therapy
Omission of radiation therapy (adjuvant endocrine therapy only).
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Local recurrence rate after breast conserving surgery
Timepoint [1] 0 0
10 years
Secondary outcome [1] 0 0
Local-regional recurrence-free interval (LRRFI)
Timepoint [1] 0 0
10 years
Secondary outcome [2] 0 0
Distant recurrence-free interval (DRFI)
Timepoint [2] 0 0
10 years
Secondary outcome [3] 0 0
Disease free survival including DCIS (DFS-DCIS)
Timepoint [3] 0 0
10 years
Secondary outcome [4] 0 0
Invasive disease free survival (iDFS)
Timepoint [4] 0 0
10 years
Secondary outcome [5] 0 0
Recurrence-free interval
Timepoint [5] 0 0
10 years
Secondary outcome [6] 0 0
Overall survival (OS)
Timepoint [6] 0 0
10 years
Secondary outcome [7] 0 0
Salvage RT or mastectomy rate
Timepoint [7] 0 0
10 years
Secondary outcome [8] 0 0
Adverse events for patients
Timepoint [8] 0 0
5 years
Secondary outcome [9] 0 0
Assessment of the impact of endocrine therapy
Timepoint [9] 0 0
5 years

Eligibility
Key inclusion criteria
for registration in the study:

1. Female patients aged = 50 years of any menopausal status.
2. 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
* 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.
3. 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.
4. 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).
5. No evidence of distant metastasis.
6. Eligible for and willing to have adjuvant endocrine therapy.
7. ECOG performance status 0-2.
8. 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
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Any one of the following is regarded as a criterion for exclusion from the study:

1. 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;
* Presence of lymphovascular invasion
2. Contra-indication or unwillingness to have adjuvant endocrine therapy.
3. 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.
4. Treated with neoadjuvant endocrine therapy, chemotherapy or biologic therapy prior to breast cancer surgery.
5. Prior breast or thoracic RT for any condition.
6. Pre-operative breast imaging evidence of disease aside from the primary carcinoma resected by breast conserving surgery.
7. Concurrent invasive breast carcinoma or ductal carcinoma in situ (synchronous or metachronous).
8. Prior diagnosis of invasive breast carcinoma or ductal carcinoma in situ in either breast irrespective of disease free interval.
9. 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.
10. Significant comorbidity precluding definitive RT for breast cancer (e.g. cardiovascular or pulmonary disease, scleroderma, systemic lupus erythematosus).
11. Life expectancy <10 years.
12. Documented mutation of BRCA1, BRCA2 or TP53, or at high genetic risk of breast cancer.
13. Pregnant or lactating patients.
14. Inability to be registered to the study =8 weeks after the last surgical procedure for breast cancer.
15. Inability to commence RT (if randomised to receive RT) no later than 12 weeks from the last surgical procedure for breast cancer.
16. Inability to provide written informed consent.
17. Psychiatric, addictive, or any disorder that precludes compliance with protocol requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
1167
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Macarthur Cancer Therapy Centre - Campbelltown
Recruitment hospital [3] 0 0
The Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [4] 0 0
St Vincent's Hospital, Sydney - Darlinghurst
Recruitment hospital [5] 0 0
Genesis Cancer Care Newcastle - Gateshead
Recruitment hospital [6] 0 0
Gosford Hospital - Gosford
Recruitment hospital [7] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [8] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [9] 0 0
Mater Hospital Sydney - North Sydney
Recruitment hospital [10] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [11] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [12] 0 0
Tamworth Rural Referral Hospital - Tamworth;
Recruitment hospital [13] 0 0
Westmead Hospital - Westmead
Recruitment hospital [14] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [15] 0 0
Genesis Cancer Care Wesley - Auchenflower
Recruitment hospital [16] 0 0
Cancer Care Service - Bundaberg - Bundaberg
Recruitment hospital [17] 0 0
Cancer Care Service - Hervey Bay - Bundaberg
Recruitment hospital [18] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [19] 0 0
GenesisCare Tennyson - Kurralta Park
Recruitment hospital [20] 0 0
Ballarat Austin Radiation Oncology Centre - Ballarat
Recruitment hospital [21] 0 0
Peter MacCallum Cancer Centre - Bendigo - Bendigo
Recruitment hospital [22] 0 0
Peter MacCallum Cancer Centre - Moorabin - Bentleigh East
Recruitment hospital [23] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [24] 0 0
Icon Cancer Centre Richmond - East Melbourne
Recruitment hospital [25] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [26] 0 0
GenesisCare Radiation Oncology Centre Frankston - Frankston
Recruitment hospital [27] 0 0
University Hospital Geelong - Geelong
Recruitment hospital [28] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [29] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [30] 0 0
Ringwood Radiation Oncology Centre - Ringwood East
Recruitment hospital [31] 0 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [32] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 0 0
2290 - Gateshead
Recruitment postcode(s) [6] 0 0
2250 - Gosford
Recruitment postcode(s) [7] 0 0
1871 - Liverpool
Recruitment postcode(s) [8] 0 0
2298 - Newcastle
Recruitment postcode(s) [9] 0 0
2060 - North Sydney
Recruitment postcode(s) [10] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [11] 0 0
2031 - Randwick
Recruitment postcode(s) [12] 0 0
2340 - Tamworth;
Recruitment postcode(s) [13] 0 0
2145 - Westmead
Recruitment postcode(s) [14] 0 0
2500 - Wollongong
Recruitment postcode(s) [15] 0 0
4066 - Auchenflower
Recruitment postcode(s) [16] 0 0
4670 - Bundaberg
Recruitment postcode(s) [17] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [18] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [19] 0 0
3353 - Ballarat
Recruitment postcode(s) [20] 0 0
3550 - Bendigo
Recruitment postcode(s) [21] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [22] 0 0
3128 - Box Hill
Recruitment postcode(s) [23] 0 0
3002 - East Melbourne
Recruitment postcode(s) [24] 0 0
3065 - Fitzroy
Recruitment postcode(s) [25] 0 0
3199 - Frankston
Recruitment postcode(s) [26] 0 0
3220 - Geelong
Recruitment postcode(s) [27] 0 0
3084 - Heidelberg
Recruitment postcode(s) [28] 0 0
8006 - Melbourne
Recruitment postcode(s) [29] 0 0
3135 - Ringwood East
Recruitment postcode(s) [30] 0 0
3844 - Traralgon
Recruitment postcode(s) [31] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Santa Fe
Country [2] 0 0
Argentina
State/province [2] 0 0
Sarmiento
Country [3] 0 0
Chile
State/province [3] 0 0
Region Metropolitana
Country [4] 0 0
Chile
State/province [4] 0 0
Antofagasta
Country [5] 0 0
Chile
State/province [5] 0 0
Puente Alto
Country [6] 0 0
Chile
State/province [6] 0 0
San Miguel
Country [7] 0 0
Chile
State/province [7] 0 0
Santiago
Country [8] 0 0
Ireland
State/province [8] 0 0
Dublin
Country [9] 0 0
Ireland
State/province [9] 0 0
Galway
Country [10] 0 0
Italy
State/province [10] 0 0
Lecco
Country [11] 0 0
Italy
State/province [11] 0 0
Milan
Country [12] 0 0
New Zealand
State/province [12] 0 0
Christchurch
Country [13] 0 0
New Zealand
State/province [13] 0 0
Hamilton
Country [14] 0 0
New Zealand
State/province [14] 0 0
Palmerston North
Country [15] 0 0
New Zealand
State/province [15] 0 0
Wellington
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Lleida
Country [18] 0 0
Spain
State/province [18] 0 0
Seville
Country [19] 0 0
Switzerland
State/province [19] 0 0
Chêne-Bougeries
Country [20] 0 0
Switzerland
State/province [20] 0 0
Locarno
Country [21] 0 0
Switzerland
State/province [21] 0 0
Winterthur
Country [22] 0 0
Switzerland
State/province [22] 0 0
Zurich
Country [23] 0 0
Taiwan
State/province [23] 0 0
Changhua
Country [24] 0 0
Taiwan
State/province [24] 0 0
Kaohsiung
Country [25] 0 0
Taiwan
State/province [25] 0 0
Taichung
Country [26] 0 0
Taiwan
State/province [26] 0 0
Tainan
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taipei
Country [28] 0 0
Taiwan
State/province [28] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Other
Name
Breast Cancer Trials, Australia and New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Breast International Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
ETOP IBCSG Partners Foundation
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Heath Badger
Address 0 0
Breast Cancer Trials, Australia and New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Heath Badger
Address 0 0
Country 0 0
Phone 0 0
+61 2 4925 3022
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised Individual Patient Data (IPD) collected during the trial as per BCT Data Sharing Guidelines.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Analytic code
When will data be available (start and end dates)?
Data will be made available for request after publication of the main/final study results; no end date.
Available to whom?
Subject to approval by Breast Cancer Trials: contact [email protected] for further information.

Note that there may be additional circumstances preventing BCT from sharing requested data as outlined in the BCT Data Sharing Guidelines .
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02889874

Additional trial details provided through ANZCTR
Accrual to date
230
Recruiting in Australia
Recruitment state(s)
ACT,NSW,QLD,WA,VIC
Recruiting in New Zealand
Province(s)/district(s)
Christchurch, Palmerston North, Waikato, Wellington.
Funding & Sponsors
Funding source category [1] 11
Government body
Name [1] 11
National Health and Medical Research Council
Address [1] 11
GPO Box 1421 Canberra ACT 2601
Country [1] 11
Australia
Primary sponsor
Other Collaborative groups
Primary sponsor name
Breast Cancer Trials
Primary sponsor address
PO Box 283
The Junction NSW 2291
Primary sponsor country
Australia
Other collaborator category [1] 10
Other Collaborative groups
Name [1] 10
Breast International Group (BIG)
Address [1] 10
Blvd de Waterloo 76 B-1000 Brussels
Country [1] 10
Belgium
Ethics approval
Ethics application status
Approved
 
Public notes

Contacts
Principal investigator
Title 25 0
Prof
Name 25 0
Boon Chua
Address 25 0
Director of Cancer and Haematology Services Nelune Comprehensive Cancer Centre Level 1, Bright Building Prince of Wales Hospital Barker Street Randwick NSW 2031
Country 25 0
Australia
Phone 25 0
Fax 25 0
Email 25 0
Contact person for public queries
Title 26 0
Ms
Name 26 0
Corinna Beckmore
Address 26 0
Breast Cancer Trials PO Box 283 The Junction NSW 2291
Country 26 0
Australia
Phone 26 0
+61 2 4925 5235
Fax 26 0
Email 26 0
[email protected]
Contact person for scientific queries
Title 27 0
Prof
Name 27 0
Boon Chua
Address 27 0
Director of Cancer and Haematology Services Nelune Comprehensive Cancer Centre Level 1, Bright Building Prince of Wales Hospital Barker Street Randwick NSW 2031
Country 27 0
Australia
Phone 27 0
+61 2 4925 5235
Fax 27 0
Email 27 0
[email protected]