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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03906669




Registration number
NCT03906669
Ethics application status
Date submitted
18/09/2018
Date registered
8/04/2019
Date last updated
8/04/2019

Titles & IDs
Public title
A Window of Opportunity Study of Pre-operative Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Breast Hormone Receptor Positive (HR+) Human Epidermal Receptor 2 Negative (HER2-) Breast Cancer.
Scientific title
A Window of Opportunity Study of Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Hormone Receptor-positive Breast Cancer.
Secondary ID [1] 0 0
ACTRN1261000928213
Universal Trial Number (UTN)
Trial acronym
WinPro
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early-stage Breast Cancer 0 0
Hormone Receptor Positive Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Letrozole
Treatment: Drugs - Letrozole and Prometrium
Treatment: Drugs - Tamoxifen and Prometrium

Active Comparator: Letrozole - Letrozole 2.5mg PO daily for 14 days between diagnosis of breast cancer and definite surgery

Experimental: Letrozole and Prometrium - Letrozole 2.5mg PO daily and Prometrium 300mg PO daily for 14 days between diagnosis of breast cancer and definite surgery

Experimental: Tamoxifen and Prometrium - Tamoxifen 20mg PO daily and Prometrium 300mg PO daily for 14 days between diagnosis of breast cancer and definite surgery


Treatment: Drugs: Letrozole
PO daily for 14 days

Treatment: Drugs: Letrozole and Prometrium
PO daily for 14 days

Treatment: Drugs: Tamoxifen and Prometrium
PO daily for 14 days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Geometric mean suppression of proliferation marker Ki67 - The geometric mean suppression of the centrally assessed proliferation marker Ki67, after two weeks of intervention, compared with baseline
Timepoint [1] 0 0
After two weeks of intervention, compared with baseline
Secondary outcome [1] 0 0
Safety and tolerability: number of participants with treatment-related adverse events as assessed by CTCAE v4.0 - Safety and tolerability of combination therapy (NCI-CTCAE v4.0)
Timepoint [1] 0 0
2 years

Eligibility
Key inclusion criteria
1. Histologically confirmed ER+ and PR+ breast cancer (defined as =10% positive staining
cells)

2. Histologically confirmed HER2-negative breast cancer (defined as IHC 0-1 and/or
FISH/CISH <2.2)

3. Tumour size =1 cm as measured by ultrasound and/or mammogram

4. Ability to understand all patient information and informed-consent documents, written
informed consent to participate in the trial, and to avail tissue and blood samples
for research

5. Aged 18 years or older
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women currently on hormone therapies, including hormone replacement therapy and oral
contraceptive pill

2. Locally advanced/inoperable and inflammatory breast cancer

3. Planned for a mastectomy (due to increased risk of venous thromboembolism)

4. Clinical evidence of metastatic disease

5. Patients treated with other preoperative systemic therapies

6. Nut allergy (prometrium contains peanut oil)

7. Prior history of uterine cancer, deep vein thrombosis, pulmonary embolism or clotting
disorder

8. Women who are pregnant or breast-feeding

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
Phase 2
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
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
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
St. Vincent's Hospital-Manhattan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A phase II randomised, open label study of pre-operative endocrine therapy with & without
prometrium in postmenopausal women with early stage breast hormone receptor positive (HR+)
human epidermal receptor 2 negative (HER2-) breast cancer.
Trial website
https://clinicaltrials.gov/show/NCT03906669
Trial related presentations / publications
Mohammed H, Russell IA, Stark R, Rueda OM, Hickey TE, Tarulli GA, Serandour AA, Birrell SN, Bruna A, Saadi A, Menon S, Hadfield J, Pugh M, Raj GV, Brown GD, D'Santos C, Robinson JL, Silva G, Launchbury R, Perou CM, Stingl J, Caldas C, Tilley WD, Carroll JS. Progesterone receptor modulates ERa action in breast cancer. Nature. 2015 Jul 16;523(7560):313-7. doi: 10.1038/nature14583. Epub 2015 Jul 8. Erratum in: Nature. 2015 Oct 1;526(7571):144. Serandour, Aurelien A A[Corrected to Serandour, Aurelien A].
Lim E, Tarulli G, Portman N, Hickey TE, Tilley WD, Palmieri C. Pushing estrogen receptor around in breast cancer. Endocr Relat Cancer. 2016 Dec;23(12):T227-T241. Epub 2016 Oct 11. Review.
Public notes

Contacts
Principal investigator
Name 0 0
Elgene Lim, MBBS FRACP PhD
Address 0 0
Garvan Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Robert Kent
Address 0 0
Country 0 0
Phone 0 0
+61293555611
Fax 0 0
Email 0 0
SVHS.CancerResearch@svha.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03906669