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EXamining PErsonalised Radiation Therapy for Low-risk Early Breast Cancer (EXPERT)

Primary Purpose

Early Stage Breast Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Omission of radiation therapy
Sponsored by
Breast Cancer Trials, Australia and New Zealand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Stage Breast Carcinoma focused on measuring Radiation therapy, omission, non-inferiority, breast cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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.

Sites / Locations

  • Sanatorio Britanico RosariioRecruiting
  • Instituto de Oncologia de RosarioRecruiting
  • Clinica ViedmaRecruiting
  • The Canberra HospitalRecruiting
  • Macarthur Cancer Therapy CentreRecruiting
  • The Chris O'Brien LifehouseRecruiting
  • St Vincent's Hospital, SydneyRecruiting
  • Genesis Cancer Care NewcastleRecruiting
  • Gosford HospitalRecruiting
  • Liverpool HospitalRecruiting
  • Calvary Mater NewcastleRecruiting
  • Mater Hospital SydneyRecruiting
  • Port Macquarie Base HospitalRecruiting
  • Prince of Wales HospitalRecruiting
  • Tamworth Rural Referral HospitalRecruiting
  • Westmead HospitalRecruiting
  • Wollongong HospitalRecruiting
  • Genesis Cancer Care WesleyRecruiting
  • Cancer Care Service - BundabergRecruiting
  • Cancer Care Service - Hervey BayRecruiting
  • Princess Alexandra HospitalRecruiting
  • GenesisCare TennysonRecruiting
  • Ballarat Austin Radiation Oncology CentreRecruiting
  • Peter MacCallum Cancer Centre - BendigoRecruiting
  • Peter MacCallum Cancer Centre - MoorabinRecruiting
  • Box Hill HospitalRecruiting
  • Icon Cancer Centre RichmondRecruiting
  • St Vincent's Hospital MelbourneRecruiting
  • GenesisCare Radiation Oncology Centre FrankstonRecruiting
  • University Hospital GeelongRecruiting
  • Austin HospitalRecruiting
  • Peter MacCallum Cancer CentreRecruiting
  • Ringwood Radiation Oncology CentreRecruiting
  • Latrobe Regional HospitalRecruiting
  • Sir Charles Gairdner HospitalRecruiting
  • Hospital Luis Tisne BrousseRecruiting
  • Centro Oncologico del NorteRecruiting
  • Hospital Sotero del RioRecruiting
  • Hospital Barros Luco TrudeauRecruiting
  • Instituto Nacional del CancerRecruiting
  • Christchurch HospitalRecruiting
  • Waikato HospitalRecruiting
  • Palmerston North HospitalRecruiting
  • Wellington HospitalRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Clinic de BarcelonaRecruiting
  • Hospital Universitari Arnoa de Vilanova de LleidaRecruiting
  • Hospital Universitario Virgen de la MacarenaRecruiting
  • Hospital Universitario Virgen del RocioRecruiting
  • Hirslanden Clinique des GrangettesRecruiting
  • Fondazione Oncologia Lago Maggiore
  • Kantonsspital WinterthurRecruiting
  • Brust-Zentrum AG ZurichRecruiting
  • Universitatsspital ZurichRecruiting
  • Changhua Christian HospitalRecruiting
  • Kaohsiung Medical University HospitalRecruiting
  • Taichung Veterans General HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Mackay Memorial HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Tri-Service General HospitalRecruiting
  • Chang-Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

A: Radiation Therapy & endocrine therapy

B: No Radiation Therapy (ET only)

Arm Description

Patients randomized to Arm A will receive standard radiation therapy and adjuvant endocrine therapy (standard of care).

Patients randomized to Arm B will not receive radiation therapy (omission of radiation therapy) and receive adjuvant endocrine therapy only.

Outcomes

Primary Outcome Measures

Local recurrence rate after breast conserving surgery
The time from randomisation to the date of local recurrence (LR) as a site of first recurrence.

Secondary Outcome Measures

Local-regional recurrence-free interval (LRRFI)
Time from randomisation to the date of local or regional recurrence as a site of first recurrence.
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.
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.
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.
Recurrence-free interval
Time from randomisation to the date of local, regional or distant recurrence as a site of first recurrence.
Overall survival (OS)
Time from randomisation to date of death from any cause.
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.
Adverse events for patients
Adverse events during treatment (up to 5 years of endocrine therapy) assessed using NCI CTCAE v4.0.
Assessment of the impact of endocrine therapy
FACT-ES measure of endocrine symptoms.

Full Information

First Posted
August 25, 2016
Last Updated
November 22, 2022
Sponsor
Breast Cancer Trials, Australia and New Zealand
Collaborators
Breast International Group, ETOP IBCSG Partners Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02889874
Brief Title
EXamining PErsonalised Radiation Therapy for Low-risk Early Breast Cancer
Acronym
EXPERT
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Breast Cancer Trials, Australia and New Zealand
Collaborators
Breast International Group, ETOP IBCSG Partners Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage Breast Carcinoma
Keywords
Radiation therapy, omission, non-inferiority, breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1167 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: Radiation Therapy & endocrine therapy
Arm Type
No Intervention
Arm Description
Patients randomized to Arm A will receive standard radiation therapy and adjuvant endocrine therapy (standard of care).
Arm Title
B: No Radiation Therapy (ET only)
Arm Type
Experimental
Arm Description
Patients randomized to Arm B will not receive radiation therapy (omission of radiation therapy) and receive adjuvant endocrine therapy only.
Intervention Type
Radiation
Intervention Name(s)
Omission of radiation therapy
Intervention Description
Omission of radiation therapy (adjuvant endocrine therapy only).
Primary Outcome Measure Information:
Title
Local recurrence rate after breast conserving surgery
Description
The time from randomisation to the date of local recurrence (LR) as a site of first recurrence.
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Local-regional recurrence-free interval (LRRFI)
Description
Time from randomisation to the date of local or regional recurrence as a site of first recurrence.
Time Frame
10 years
Title
Distant recurrence-free interval (DRFI)
Description
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.
Time Frame
10 years
Title
Disease free survival including DCIS (DFS-DCIS)
Description
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.
Time Frame
10 years
Title
Invasive disease free survival (iDFS)
Description
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.
Time Frame
10 years
Title
Recurrence-free interval
Description
Time from randomisation to the date of local, regional or distant recurrence as a site of first recurrence.
Time Frame
10 years
Title
Overall survival (OS)
Description
Time from randomisation to date of death from any cause.
Time Frame
10 years
Title
Salvage RT or mastectomy rate
Description
Time from randomisation to the receipt of salvage RT or mastectomy, individually and in combination (one or the other) as a composite endpoint.
Time Frame
10 years
Title
Adverse events for patients
Description
Adverse events during treatment (up to 5 years of endocrine therapy) assessed using NCI CTCAE v4.0.
Time Frame
5 years
Title
Assessment of the impact of endocrine therapy
Description
FACT-ES measure of endocrine symptoms.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Quality of Life: Fear of recurrence
Description
Fear of Cancer Recurrence Inventory
Time Frame
5 years
Title
Quality of Life: Convenience of care
Description
Visual Analogue Scales (convenience and impact of treatment)
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: for registration in the study: 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 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 Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heath Badger
Phone
+61 2 4925 3022
Email
expert@bctrials.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Akiko Fong
Phone
+61 2 4925 3022
Email
expert@bctrials.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heath Badger
Organizational Affiliation
Breast Cancer Trials, Australia and New Zealand
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Boon H Chua, Prof
Organizational Affiliation
Prince of Wales Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sanatorio Britanico Rosariio
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo Tatangelo, Dr
Facility Name
Instituto de Oncologia de Rosario
City
Santa Fe
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Fein, Dr
Facility Name
Clinica Viedma
City
Sarmiento
ZIP/Postal Code
R8500ACE
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruben Kowalyszsyn, Dr
Facility Name
The Canberra Hospital
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Sullivan, Dr
Facility Name
Macarthur Cancer Therapy Centre
City
Campbelltown
State/Province
New South Wales
ZIP/Postal Code
2560
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Papadatos, Dr
Facility Name
The Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgia Harris, Dr
Facility Name
St Vincent's Hospital, Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne Toohey, Dr
Facility Name
Genesis Cancer Care Newcastle
City
Gateshead
State/Province
New South Wales
ZIP/Postal Code
2290
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter O'Brien, A/Prof
Facility Name
Gosford Hospital
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hester Lieng, Dr
First Name & Middle Initial & Last Name & Degree
Hester Lieng, Dr
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
1871
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Boxer, Dr
Facility Name
Calvary Mater Newcastle
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Ludbrook, Dr
Facility Name
Mater Hospital Sydney
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Spillane, Prof
Facility Name
Port Macquarie Base Hospital
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Hansen, Dr
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boon H Chua, Prof
Facility Name
Tamworth Rural Referral Hospital
City
Tamworth;
State/Province
New South Wales
ZIP/Postal Code
2340
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Pendlebury, Dr
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Verity Ahern, A/Prof
Facility Name
Wollongong Hospital
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
de Leon Jeremiah, Dr
Facility Name
Genesis Cancer Care Wesley
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Burke, Dr
Facility Name
Cancer Care Service - Bundaberg
City
Bundaberg
State/Province
Queensland
ZIP/Postal Code
4670
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerard Adams, Dr
Facility Name
Cancer Care Service - Hervey Bay
City
Bundaberg
State/Province
Queensland
ZIP/Postal Code
4670
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bryan Burmeister, Prof
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margot Lehman, A/Prof
Facility Name
GenesisCare Tennyson
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phuong Tran, Dr
Facility Name
Ballarat Austin Radiation Oncology Centre
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3353
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Gorman, Dr
Facility Name
Peter MacCallum Cancer Centre - Bendigo
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3550
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Solveig Grenfell, Dr
Facility Name
Peter MacCallum Cancer Centre - Moorabin
City
Bentleigh East
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven David, Dr
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bianca Devitt, Dr
Facility Name
Icon Cancer Centre Richmond
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew See, Dr
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Moore, Dr
Facility Name
GenesisCare Radiation Oncology Centre Frankston
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Blakey, Dr
Facility Name
University Hospital Geelong
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Francis, Dr
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Chao, Dr
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
8006
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prue Francis, A/Prof
Facility Name
Ringwood Radiation Oncology Centre
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Chao, Dr
Facility Name
Latrobe Regional Hospital
City
Traralgon
State/Province
Victoria
ZIP/Postal Code
3844
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Nardone, Dr
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandy Taylor, Dr
Facility Name
Hospital Luis Tisne Brousse
City
Santiago
State/Province
Region Metropolitana
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paola Ruiz de Vinaspre, Dr
Facility Name
Centro Oncologico del Norte
City
Antofagasta
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paves Gonzalo, Dr
Facility Name
Hospital Sotero del Rio
City
Puente Alto
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Manzor, Dr
Facility Name
Hospital Barros Luco Trudeau
City
San Miguel
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocio Guerra, Dr
Facility Name
Instituto Nacional del Cancer
City
Santiago
ZIP/Postal Code
1010
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camila Concha, Dr
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa James, Dr
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Campbell, A/Prof
Facility Name
Palmerston North Hospital
City
Palmerston North
ZIP/Postal Code
4414
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Hardie, Dr
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Nicholson, Dr
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Reyes, Dr
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meritxell Molla, Dr
Facility Name
Hospital Universitari Arnoa de Vilanova de Lleida
City
Lleida
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serafin Morales, Dr
Facility Name
Hospital Universitario Virgen de la Macarena
City
Seville
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eloisa Bayo, Dr
Facility Name
Hospital Universitario Virgen del Rocio
City
Seville
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Salvador Bofill, Dr
Facility Name
Hirslanden Clinique des Grangettes
City
Chêne-Bougeries
ZIP/Postal Code
1224
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Conny Vrieling, Dr
Facility Name
Fondazione Oncologia Lago Maggiore
City
Locarno
ZIP/Postal Code
6600
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michail Kouros, Dr
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8400
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Zwahlen, Dr
Facility Name
Brust-Zentrum AG Zurich
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Tausch, Dr
Facility Name
Universitatsspital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linsenmeier Claudia, Dr
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shou-Tung Chen, Dr
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang-Ming Chen, Dr
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407204
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih-Chiang Hung, Dr
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao-Lung Kuo, Dr
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiun-Sheng Huang, Dr
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan-ching Chang, Dr
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling-Ming Tseng, Dr
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo-Hsiou Liao, Dr
Facility Name
Chang-Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenling Kuo, Dr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised Individual Patient Data (IPD) collected during the trial as per BCT Data Sharing Guidelines.
IPD Sharing Time Frame
Data will be made available for request after publication of the main/final study results; no end date.
IPD Sharing Access Criteria
Subject to approval by Breast Cancer Trials: contact concept@bctrials.org.au for further information. Note that there may be additional circumstances preventing BCT from sharing requested data as outlined in the BCT Data Sharing Guidelines .
Links:
URL
https://www.breastcancertrials.org.au/home
Description
Breast Cancer Trials (formerly Australia & New Zealand Breast Cancer Trials Group

Learn more about this trial

EXamining PErsonalised Radiation Therapy for Low-risk Early Breast Cancer

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