Clinical trial · Interventional
The EMPOwER Study Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers
Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers: The EMPOwER Study
NCT03211572CI-TRIAL-00028523OTT 17-01unknownPhase 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)
Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endocrine Therapy
- description
- Anastrozole 1 mg (postmenopausal) or tamoxifen 20mg (premenopausal) are to be taken orally each evening and would be started exactly 2 weeks prior to their surgery.
- interventionNames
- Drug: Tamoxifen
Primary outcomes (1)
- measure
- Endocrine Therapy response
- timeFrame
- at one year
- description
- Introduction and validation of the use of NanoString® technology and a development of a custom gene codeset predictive of endocrine therapy response into the window setting as a more robust and reliable method of biomarker assessment as compared to Ki67.
Secondary outcomes (1)
- measure
- Biomarker Predictive value
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient with histologically confirmed newly diagnosed operable ER+, Her2 negative invasive carcinoma on diagnostic core biopsy that has a radiographic size ≥ 1.5 cm * Histology has to be ductal, lobular or mixed * Surgery date planned in the next 2-6 weeks * Negative pregnancy test if of child baring potential * Post-menopausal status verified by FSH and Estradiol (with 6 months of amenorrhea) Exclusion Criteria: * Previous treatment with endocrine therapy, chemotherapy or chest wall radiation within last 6 months * Known metastatic or recurrent breast cancer.
References
Publications (0)
Data not yet available
No reference posted for this study.