Pre-operative hormone therapy with and without Prometrium for early-stage breast cancer in postmenopausal women
A Window of Opportunity Study of Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Hormone Receptor-positive Breast Cancer.
This study is testing whether adding a natural hormone called Prometrium to standard breast cancer treatments helps postmenopausal women with early-stage hormone receptor positive breast cancer before their surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | St Vincent's Hospital Academic / other |
| Locations | 1 site (Sydney, New South Wales) |
| Trial ID | NCT03906669 on ClinicalTrials.gov |
What this trial studies
This phase II randomized, open-label study investigates the effects of pre-operative endocrine therapy in postmenopausal women with early-stage hormone receptor positive (HR+) and HER2-negative breast cancer. Participants will be randomly assigned to receive either letrozole alone, letrozole with Prometrium, or tamoxifen with Prometrium for 14 days before surgery. The study aims to explore the potential additive anti-cancer effects of combining natural progesterone with standard endocrine therapies. The research will involve 200 eligible women and will assess the impact of these treatments on tumor characteristics prior to definitive surgery.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 18 and older with early-stage ER+, PR+, HER2-negative breast cancer.
Not a fit: Patients with locally advanced or inflammatory breast cancer, or those currently on hormone therapies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of pre-operative treatments for early-stage breast cancer, potentially improving patient outcomes.
How similar studies have performed: While the specific combination of treatments in this study is novel, previous studies have shown promising results with similar approaches in hormone receptor positive breast cancer.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sydney, New South Wales
- St Vincent's Hospital — Sydney, New South Wales, Australia (Recruiting)
Study contacts
- Principal investigator: Elgene Lim, MBBS FRACP PhD — Garvan Research Institute
- Study coordinator: Robert Kent
- Email: SVHS.CancerResearch@svha.org.au
- Phone: +61293555611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.