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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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001284257
Ethics application status
Approved
Date submitted
18/03/2016
Date registered
30/07/2018
Date last updated
30/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
This study will examine the impact of a prognostic gene profiling test EndoPredict® – on adjuvant treatment recommendations in early breast cancer patients, who are ER positive seen at Westmead BCI, VCCC or St Vincent's Hospital.
Scientific title
'This is a prospective study designed to evaluate the impact of the EndoPredict® test to change treatment decisions regarding adjuvant chemotherapy for women with breast cancer'
Secondary ID [1] 294756 0
None
Universal Trial Number (UTN)
Trial acronym
PROSPER 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Breast Cancer with ER/PR positive and HER2 Negative 298058 0
Condition category
Condition code
Cancer 298220 298220 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All consenting and eligible patients will be enrolled into the Study. For the enrolled patients, the allocated pathologist will select the appropriate tumour material for testing with the EndoPredict® . All enrolled patients will be discussed at a multidisciplinary team (MDT) meeting, no later than 14 days from their surgical date. Adjuvant treatment decisions regarding chemotherapy and hormonal therapy will be documented, based firstly on the standard histopathology results only (including Ki-67) (the Initial MDT Recommendation) and secondly, on the basis of additional information from the EndoPredict® test result (the Final MDT Recommendation). Information regarding the specific chemotherapy and endocrine regimen, including name of drug, and intended treatment duration, will be recorded if the information is routinely avaialable. If not, site needs to document if chemotherapy, chemotherapy plus endocrine therapy or radiotherapy is recommended .
Patients will be seen by the treating clinician (medical oncologist/breast surgeon) who will deliver and discuss the final MDT recommendation. Should the treating clinician medical oncologist not accept the final MDT recommendation, and another treatment (Clinical Treatment Decision) was recommended upon meeting the patient, the treatment change and the reason for this change will be documented.
Should the patient not accept the recommendation of the medical oncologist, then the reason for the refusal should be documented (Final Treatment Plan).
This Study will record the treatment that was actually received by the patient (Actual Treatment – type and duration). Patients enrolled in this study will be followed up annually in clinic for a total 10 years. Long-term follow-up (greater than 10 years) will record dates of breast cancer recurrence and death only, if feasible.
Intervention code [1] 294244 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297723 0
It will examine the proportion of patients whose recommendations were changed from recommending chemotherapy to not recommending chemotherapy or recommending Endocrine therapy only to chemotherapy plus endocrine therapy after the results of the endopredict results are made available to the clinicians by reviewing the medical record.
Timepoint [1] 297723 0
.
We will know the MDT recommendation change 2 weeks after the surgery. But data analysis will happen at 1 year after the recommendation.
Secondary outcome [1] 322011 0

ki-67 expression from surgical specimen will be compared with the EPclin scores of EndoPredict® to check how they correlate.
Timepoint [1] 322011 0
At one year after the surgery.

Eligibility
Key inclusion criteria
Females (18 – 80 years)
ECOG Performance Status 0-1
Resected estrogen-receptor-positive, HER2-negative, early stage invasive breast cancer (T1-T2N0-1M0)
Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells of any intensity will be considered positive.
HER2 status will be evaluated by in situ hybridisation using current ASCOCAP guidelines for scoring (HER2:CEP17 ratio >2 will be considered positive
Minimum age
18 Years
Maximum age
80 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Tumor size T3-T4
Non-invasive breast cancer (e.g., Paget's disease, DCIS)
Greater than 3 involved axillary nodes
Tumors that are estrogen-receptor negative or HER2 positive
Distant metastatic disease
Unable to give informed consent Significant co-morbidities or contraindications for adjuvant chemotherapy
ECOG Performance Status 2-4

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Analysis will be performed using SPSS version 23 by the WLHD statistician. The pre and post Prosigna recommendations are collated and compared at the conclusion of the study Chi-square test or Fishers exact test will be used to compare the difference in the recommendations without and with Prosigna test results. Univariate comparisons will be performed using chi-square tests for equal proportion, student t-tests for normally distributed outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 5468 0
Westmead Hospital - Westmead
Recruitment hospital [2] 11131 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [3] 11132 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 22948 0
2145 - Wentworthville
Recruitment postcode(s) [2] 22949 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 22950 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 293159 0
Hospital
Name [1] 293159 0
Westmead Breast Cancer Institute, westmead Hospital
Address [1] 293159 0
Westmead Breast Cancer Institute
Level 1, Westmead Hospital
Cnr Hawkesbury and Darcy Ro, Westmead, NSW 2145
Country [1] 293159 0
Australia
Primary sponsor type
Hospital
Name
Westmead Breast cancer Institute, Westmead Hospital
Address
Westmead Breast Cancer Institute
Cnr Darcy and Hawkesbury Roads, Westmead NSW l PO Box 143 Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 291954 0
Commercial sector/Industry
Name [1] 291954 0
Myriad Genetics Pty Ltd ,
Address [1] 291954 0
Level 12 / 222 Pitt Street, Sydney, NSW 2000
Country [1] 291954 0
Australia
Other collaborator category [1] 280094 0
Hospital
Name [1] 280094 0
The Royal Melbourne Hospital
Address [1] 280094 0
300 Grattan street Parkville, Vic 3050
Country [1] 280094 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294652 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 294652 0
Po Box 574, Wentworthville NSW2145
Ethics committee country [1] 294652 0
Australia
Date submitted for ethics approval [1] 294652 0
17/08/2015
Approval date [1] 294652 0
05/11/2015
Ethics approval number [1] 294652 0
(4460) AU RED LNR/15/WMEAD/429

Summary
Brief summary
This study will examine the impact of prognostic gene profile testing using EndoPredict on adjuvant treatment recommendations in early breast cancer patients who are ER positive.

Who is it for?
You may be eligible for this study if you are a female aged between 18-80 years and have early stage invasive breast cancer which is estrogen receptor positive and HER2 negative. Potential participants will also need to be patients at the Westmead Breast Cancer Institute, Victorian Comprehensive Cancer Centre and St Vincent’s Hospital Sydney.

Study details
This study will involve participants going through their usual cancer treatment. Participants will be followed up for 10 years on an annual basis to assess treatment recommendations and decisions in that time.
This study will enable the researchers to accurately identify those women who can safely avoid chemotherapy
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2652 2652 0 0

Contacts
Principal investigator
Name 64490 0
A/Prof Nirmala Pathmanathan
Address 64490 0
Westmead Breast Cancer Institute
Westmead Hospital
Cnr Darcy and Hawkesbury Roads, Westmead NSW PO Box 143
Country 64490 0
Australia
Phone 64490 0
(612) 9845 8458
Fax 64490 0
612 9845 7246
Email 64490 0
nirmala.pathmanathan@health.nsw.gov.au
Contact person for public queries
Name 64491 0
Ms Masrura Kabir
Address 64491 0
Westmead Breast Cancer Institute
Westmead Hospital

Cnr Darcy and Hawkesbury Roads, Westmead NSW 2145
Country 64491 0
Australia
Phone 64491 0
612 9845 9684
Fax 64491 0
612 9845 7246
Email 64491 0
masrura.kabir@health.nsw.gov.au
Contact person for scientific queries
Name 64492 0
A/Prof Nirmala Pathmanathan
Address 64492 0
Westmead Breast Cancer Institute
Westmead Hospital
Cnr Darcy and Hawkesbury Roads, Westmead NSW 2145
Country 64492 0
Australia
Phone 64492 0
T +61 2 9845 5200
Fax 64492 0
61 2 9845 6391
Email 64492 0
Nirmala.pathmanathan@health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results