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.

Launched by ST VINCENT'S HOSPITAL · Apr 5, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment approach for postmenopausal women with early-stage breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 negative (HER2-). The study is looking at the effects of a pre-operative endocrine therapy, with and without a medication called Prometrium, to see how it may help before surgery. The goal is to better understand how these treatments work for women whose cancer is sensitive to hormones.

To participate, women must be at least 18 years old and have a confirmed diagnosis of HR+ and HER2- breast cancer with a tumor size of at least 1 cm. However, those currently on hormone therapies, with certain medical conditions, or who are pregnant or breastfeeding cannot join. If eligible, participants will receive one of the treatment options and will be closely monitored throughout the study. This trial is actively recruiting, and it offers an opportunity to contribute to important research that could improve future breast cancer treatments.

Gender

FEMALE

Eligibility criteria

• 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
• 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