Trial purpose
Cancer treatment
Tumor type
Breast
Age
18+
Clinical summary
Summary
This is a randomised, open label study recruiting postmenopausal women with early-stage ER+, PR+, HER-negative breast cancer. The trial has three arms, each running for 14 days. Participants will receive treatment after diagnosis but prior to surgery. In Arm 1, participants will receive letrozole 2.5mg, administered orally once daily. In Arm 2, participants will receive letrozole 2.5mg and prometrium 300mg, administered orally once daily. In Arm 3, participants will receive tamoxifen 20mg and prometrium 300mg, administered orally once daily.
Conditions
This trial is treating patients with early stage ER+, PR+, HER-negative breast cancer
Eligibility
Inclusion
- 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
Exclusion
- Women currently on hormone therapies, including hormone replacement therapy and oral contraceptive pill
- Locally advanced/inoperable and inflammatory breast cancer
- Planned for a mastectomy (due to increased risk of venous thromboembolism)
- Clinical evidence of metastatic disease
- Patients treated with other preoperative systemic therapies
- Nut allergy (prometrium contains peanut oil)
- Prior history of uterine cancer, deep vein thrombosis, pulmonary embolism or clotting disorder
- Women who are pregnant or breast-feeding
Inclusion
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
St. Vincent's Hospital-Manhattan
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.
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