Clinical trial · Interventional
Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer
Everolimus (RAD001) in Combination With Intravenous Carboplatin in Taxane- and Anthracycline-pretreated Patients With Progressive 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)
This is an open-label, mono-center phase I/II study designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of RAD001 in combination with carboplatin in taxane- and anthracycline-pretreated patients with progressive metastatic breast cancer. Additionally, the study is designed to characterize the safety, the tolerability and efficacy of this study.
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 |
|---|---|---|---|
| RAD001 (Everolimus) in combination with carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Phase I: dose limiting toxicity
- timeFrame
- after three weeks
- measure
- Phase II: response rate
- timeFrame
- every six weeks
Secondary outcomes (1)
- measure
- Phase I: adverse events
- timeFrame
- after three weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult female patients * at least two prior chemotherapies due to metastatic or inoperable breast cancer * Karnofsky performance status of at least 60% * pretreatment with at least one taxane and one anthracycline Exclusion Criteria: * previous treatment with mTOR-inhibitors, carboplatin, cisplatin or oxaliplatin * inadequate organ function including bone marrow function * bleeding tumours * known uncontrolled metastases in CNS or carcinomatous meningosis * patients who have been treated during the last five days with inhibitors or inducers of CYP3A * serious pulmonary, neurological, endocrinological or other disorders interfering with this study medication, especially patients with known lung fibrosis, emphysema or severe COPD
References
Publications (0)
Data not yet available