A Window of Opportunity Study of Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Hormone Receptor-positive Breast Cancer.
Who is this study for? Patients with Breast Cancer, Tumor
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically confirmed ER+ and PR+ breast cancer (defined as ≥10% positive staining cells)
• Histologically confirmed HER2-negative breast cancer (defined as IHC 0-1 and/or FISH/CISH \<2.2)
• Tumour size ≥1 cm as measured by ultrasound and/or mammogram
• 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
• Aged 18 years or older
Locations
Other Locations
Australia
St Vincent's Hospital
RECRUITING
Sydney
Contact Information
Primary
Robert Kent
SVHS.CancerResearch@svha.org.au
+61293555611
Time Frame
Start Date: 2018-03-20
Estimated Completion Date: 2024-04
Participants
Target number of participants: 200
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: St Vincent's Hospital