Clinical trial · Interventional
The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer
NCT04129216CI-TRIAL-00076835completedPhase 2Results postedClinicalTrials.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)
The investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blueprint | Diagnostic Test | — | UNRESOLVED |
| Exemestane | Drug | Exemestane | ALIAS |
| Letrozole | Drug | Letrozole | ALIAS |
| Mammaprint | Diagnostic Test | — | UNRESOLVED |
| Tamoxifen Citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Tamoxifen arm
- description
- for premenopausal patients
- interventionNames
- Drug: Tamoxifen Citrate
- Diagnostic Test: Blueprint
- Diagnostic Test: Mammaprint
- type
- EXPERIMENTAL
- label
- Letrozole arm
- description
- for postmenopausal patients
- interventionNames
- Drug: Letrozole
- Diagnostic Test: Blueprint
- Diagnostic Test: Mammaprint
- type
- EXPERIMENTAL
- label
- Exemestane arm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion criteria * Treatment-naïve, histologically confirmed invasive ductal breast cancer between stages 1 to 3. * Co-enrollment in the FLEX Registry * Estrogen Receptor Positive (ER+) Progesterone Receptor Positive (PR+) confirmed hormone receptor status measured by immunohistochemistry (IHC) * Patients should understand patients' condition and be able to give informed consent to participate Exclusion criteria * History of hormonal therapy, chemotherapy, radiation therapy, or novel therapy to treat the current breast cancer. * Allergic reactions/hypersensitivity to tamoxifen, letrozole, or exemestane or any of the ingredients of these drugs. * Any contraindication to hormonal therapy, such as history of thromboembolic disease or uterine cancer. * Patients without invasive disease (stage 0) * Patients with metastatic breast cancer(stageIV) * Patients that are Human Epidermal Growth Factor 2+(HER2+) by IHC/Fluorescence in situ hybridization (FISH).
References
Publications (1)
- BACKGROUNDSuman VJ, Ellis MJ, Ma CX. The ALTERNATE trial: assessing a biomarker driven strategy for the treatment of post-menopausal women with ER+/Her2- invasive breast cancer. Chin Clin Oncol. 2015 Sep;4(3):34. doi: 10.3978/j.issn.2304-3865.2015.09.01. PMID 26408301