Clinical trial · Interventional
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.
A Window of Opportunity Study of Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Hormone Receptor-positive Breast Cancer.
NCT03906669CI-TRIAL-00071597WinProunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
| Hormone Receptor Positive Tumor | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
| Letrozole and Prometrium | Drug | — | UNRESOLVED |
| Tamoxifen and Prometrium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Letrozole
- description
- Letrozole 2.5mg PO daily for 14 days between diagnosis of breast cancer and definite surgery
- interventionNames
- Drug: Letrozole
- type
- EXPERIMENTAL
- label
- Letrozole and Prometrium
- description
- Letrozole 2.5mg PO daily and Prometrium 300mg PO daily for 14 days between diagnosis of breast cancer and definite surgery
- interventionNames
- Drug: Letrozole and Prometrium
- type
- EXPERIMENTAL
- label
- Tamoxifen and Prometrium
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDMohammed 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 ERalpha action in breast cancer. Nature. 2015 Jul 16;523(7560):313-7. doi: 10.1038/nature14583. Epub 2015 Jul 8. PMID 26153859
- BACKGROUNDLim 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. doi: 10.1530/ERC-16-0427. Epub 2016 Oct 11. PMID 27729416