Clinical trial · Interventional
Study of GnRH-A [Leuprorelin(Lorelin Depot] Plus Leterozole +/- Everolimus for Premenopausal Women With Metastatic Breast Cancer
Ovarian Suppression Plus Letrozole Plus Everolimus for Hormone Receptor-Positive, Tamoxifen and Ovarian Suppression Pretreated, Premenopausal Women With Recurrent or Metastatic Breast Cancer[LEO]
NCT02344550CI-TRIAL-00046279LEOcompletedPhase 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)
The purpose of this study is to evaluate the efficacy of addition of everolimus to letrozole with LHRH agonist in premenopausal metastatic breast cancer patients who failed to tamoxifen treatment.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus(afinitor) | Drug | Everolimus | ALIAS |
| Letrozole | Drug | Letrozole | ALIAS |
| Leuprolide(Lorelin Depot) | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Everolimus arm
- description
- Everolimus 10mg p.o. daily Letrozole 2.5 mg p.o. daily Leuprorelin (Leuprolide) 3.75mg SC every 4 weeks
- interventionNames
- Drug: Everolimus(afinitor)
- Drug: Letrozole
- Drug: Leuprolide(Lorelin Depot)
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- Letrozole 2.5 mg p.o. daily Leuprorelin (Leuprolide) 3.75mg SC every 4 weeks
- interventionNames
- Drug: Letrozole
- Drug: Leuprolide(Lorelin Depot)
Primary outcomes (1)
- measure
- Progression free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 20 years * Histologically or cytologically confirmed, HER-2 negative breast cancer with recurrent or metastatic disease * No HER2 overexpressing breast cancer * Premenopausal status, defined as either * ER and/or PR positive * Progressive disease on tamoxifen treatment or sequential or combined treatment of tamoxifen and GnRH agonist as a palliative or an adjuvant endocrine treatment * Duration of tamoxifen treatment should be at least 3 months or more * No prior treatment with an aromatase inhibitor or inactivator or fulvestrant, or mTOR inhibitors * One line of chemotherapy in metastatic setting is permitted * ECOG performance status 0,1 or 2 * At least one measurable lesion or mainly lytic bone lesions in the absence of measurable disease * Adequate hematologic, liver and kidney function Exclusion Criteria: * Pregnant women or patients in lactation * More than one line of prior chemotherapy for metastatic breast cancer * GnRH agonist with tamoxifen treatment within 2 weeks. * Active malignancy other than breast cancer, in situ carcinoma of the cervix, controlled resected thyroid well differentiated carcinoma or non-melanomatous skin cancer in the past 5 years * Active cardiovascular disease such as angina, ventricular tachycardia, uncontrolled hypertension * Active uncontrolled infection * Symptomatic brain metastases * Lymphangitic carcinomatosis involving \>50% of the lungs * Evidence of metastases involving more than one third of the liver on sonogram or CT * Patients not able or unwilling to give informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.