Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000695606
Ethics application status
Approved
Date submitted
26/06/2014
Date registered
2/07/2014
Date last updated
3/12/2020
Date data sharing statement initially provided
6/08/2019
Date results information initially provided
3/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
PRE-TREAT: A window study evaluating short term treatment with tamoxifen or letrozole in oestrogen receptive positive breast cancer
Scientific title
PRE-TREAT - A window study to determine short-term effects of Pre-operative Treatment with tamoxifen or letrozole on the expression of pro-survival genes in oestrogen receptor (ER) positive breast cancer
Secondary ID [1] 284874 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Pre-Treat
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 292308 0
Condition category
Condition code
Cancer 292644 292644 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tamoxifen for pre- or peri-menopausal women
20mg oral once daily for 5-7 days before surgery

Letrozole for post-menopausal women
2.5mg oral once daily for 5-7 days before surgery

All unadministered tablets will be returned. Patients will also be asked about compliance to treatment.
Intervention code [1] 289681 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292483 0
Global changes in mRNA expression, including BCL-2 family members, following short-term treatment with tamoxifen or letrozole in ER-positive breast cancer. This will be assessed by gene expression profiling and RT-PCR on paired tumour samples obtained at diagnosis and at the time of surgery.
Timepoint [1] 292483 0
At baseline (diagnosis) and after 5-7 days of treatment (at surgery)
Secondary outcome [1] 309079 0
Changes in BCL-2 protein by gene expression profiling and RT-PCR on paired tumour samples.
Timepoint [1] 309079 0
At baseline and at surgery (after 5-7 days of treatment)
Secondary outcome [2] 309080 0
Changes in ER and PR expression using immunohistochemistry
Timepoint [2] 309080 0
At baseline and at surgery (after 5-7 days of treatment)
Secondary outcome [3] 309081 0
Changes in Ki67 expression using immunohistochemistry
Timepoint [3] 309081 0
At baseline and at surgery (after 5-7 days of treatment)

Eligibility
Key inclusion criteria
1. Female
2. Histologically confirmed invasive ductal or lobular carcinoma of the breast
3. Consented to Breast Biomarker Project (TransBCR MH HREC No:2013.025)
4. Oestrogen-positive breast cancer, defined as ++ to +++, i.e. moderate to strong tumour immunostaining in >20% of the tumour cells
5. Intention to treat with surgery
6. ECOG 0-1
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known metastatic breast cancer
2. Previous invasive carcinoma of the breast
3. Pregnancy or lactation
4. Subjects deemed to require any neoadjuvant therapy prior to definitive surgery
5. Concurrent therapy with a Selective Oestrogen Receptor Modulator (SERM), aromatase inhibitor or pure ER antagonist e.g. fulvestrant
6. Prior endocrine therapy or chemotherapy
7. Contraindication to tamoxifen use for tamoxifen arm (past or strong family history of venous thromboembolic events, BMI>35, planned surgery >4 hours)
8. Current anti-coagulation therapy for thromboembolic event
9. History of severe osteoporosis defined by osteoporosis-related fractures or limiting activities of daily living in post-menopausal women

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/07/2014
Actual
23/12/2014
Date of last participant enrolment
Anticipated
Actual
19/08/2019
Date of last data collection
Anticipated
Actual
31/03/2020
Sample size
Target
20
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18149 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 32146 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 289490 0
Government body
Name [1] 289490 0
Victorian Cancer Agency
Country [1] 289490 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
The Royal Melbourne Hospital
300 Grattan Street, Parkville
3050 VIC
Country
Australia
Secondary sponsor category [1] 288175 0
None
Name [1] 288175 0
Address [1] 288175 0
Country [1] 288175 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291246 0
Melbourne Health
Ethics committee address [1] 291246 0
The Royal Melbourne Hospital
300 Grattan Street,
Parkville 3050
VIC
Ethics committee country [1] 291246 0
Australia
Date submitted for ethics approval [1] 291246 0
Approval date [1] 291246 0
12/05/2014
Ethics approval number [1] 291246 0
2014.073

Summary
Brief summary
This study aims to determine the effects of short-term treatment with endocrine therapy (tamoxifen or letrozole) when given to women with newly diagnosed oestrogen receptor positive (ER+) breast cancer.

Who is it for?
You may be eligible to join this study if you are a woman aged 18 years or above, have been recently diagnosed with oestrogen-receptor positive breast cancer. Eligible candidates must have already provided consent to be part of the Breast Biomarker Project at Royal Melbourne Hospital.

Study details
All participants in this study will receive endocrine therapy for 5-7 days prior to surgery. Pre- or peri- menopausal women will receive 20mg oral tablet of tamoxifen per day whilst post-menopausal women will receive 2.5mg oral tablet of letrozole per day. Blood and tumour samples taken at the time of diagnosis will be compared to those taken at the time of surgery to determine changes in the tumour cells. The findings from this study will provide valuable information on the changes in breast cancer cells and their "signatures" following short-term exposure to endocrine therapy, and help with development of future breast cancer treatment.
Trial website
https://www.transbcr.org.au
Trial related presentations / publications
Public notes
Study is now closed.

Contacts
Principal investigator
Name 49490 0
Prof Geoffrey Lindeman
Address 49490 0
Department of Medical Oncology
The Royal Melbourne Hospital
300 Grattan Street, Parkville
3050 VIC
Country 49490 0
Australia
Phone 49490 0
+61-3-93452611
Fax 49490 0
Email 49490 0
[email protected]
Contact person for public queries
Name 49491 0
Ms Kirsten Hogg
Address 49491 0
The Royal Melbourne Hospital
300 Grattan Street, Parkville
3050 VIC
Country 49491 0
Australia
Phone 49491 0
+61-3-93452805
Fax 49491 0
Email 49491 0
[email protected]
Contact person for scientific queries
Name 49492 0
Dr Christine Muttiah
Address 49492 0
The Royal Melbourne Hospital
300 Grattan Street, Parkville
3050 VIC
Country 49492 0
Australia
Phone 49492 0
+61-3-93452805
Fax 49492 0
Email 49492 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Given the small sample size of this window study, participant numbers are not sufficient to ensure data remains deidentified.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA phase 1b dose-escalation and expansion study of the BCL-2 inhibitor venetoclax combined with tamoxifen in ER and BCL-2-positive metastatic breast cancer2019https://doi.org/10.1158/2159-8290.cd-18-1151
N.B. These documents automatically identified may not have been verified by the study sponsor.