Clinical trial · Interventional
Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer
A Phase Ib/II Study Investigating the Combination of Everolimus With Trastuzumab and Paclitaxel in Patients With HER2-overexpressing Metastatic Breast Cancer
- 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)
Phase I: will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer. Phase II: will assess the efficacy and safety of the 10mg daily dose of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic 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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus | Drug | Everolimus | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase I - RAD001 5mg + PT, daily
- description
- Daily dosing schedule of EPT = Paclitaxel \& Trastuzumab verolimus 5mg plus Paclitaxel plus Trastuzumab.
- interventionNames
- Drug: Everolimus
- Drug: Trastuzumab
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- Phase I - RAD001 10mg + PT, daily
- description
- Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel \& Trastuzumab
- interventionNames
- Drug: Everolimus
- Drug: Trastuzumab
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female or male patients ≥ 18 years old with WHO performance status ≤ 1 * HER-2 over-expressing metastatic breast cancer cells confirmed by histology * Progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy (phase l) * Patient resistance to trastuzumab and taxanes (Phase ll) * Measurable disease according to RECIST (Phase ll) * Patients neurologically stable with adequate bone marrow, liver and renal function Exclusion Criteria: * Patients receiving endocrine therapy for breast cancer ≤ 2 weeks prior to study treatment start * Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these ≤ 4 weeks prior to study treatment start or patients who have received lapatinib ≤ 2 weeks prior to study treatment start * Patients who have previously received mTOR inhibitors Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available