Clinical trial · Observational
Prediction of Everolimus-induced Interstitial Lung Disease
Prediction of Everolimus-induced Interstitial Lung Disease in Breast Cancer Patients; Maximizing Efficacy by Reducing Toxicity
NCT01978171CI-TRIAL-00032483PREVENTcompletedClinicalTrials.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 will determine which factors are predictive for the development and severity of everolimus-induced interstitial lung disease and will develop a prediction model based on these risk factors.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- breast cancer patients
- description
- Postmenopausal women with estrogen receptor (ER) positive advanced breast cancer whose disease is refractory to non steroidal aromatase inhibitors, and are eligible for treatment with exemestane and everolimus.
Primary outcomes (1)
- measure
- predictive factors of everolimus-induced ILD
- timeFrame
- six months
- description
- Find the correlation between: * pneumoproteins * everolimus exposure * pulmonary function tests * four distinct radiological patterns of 1.0mm CT slices of the lungs * baseline patient characteristics * the development and grade of everolimus-induced skin toxicity and oral mucositis and the development and grade of everolimus-induced ILD
Secondary outcomes (3)
- measure
- temporal relation pneumoproteins and ILD
- timeFrame
- six months
- description
- Analyze the temporal relationship between a decrease in pulmonary function or the occurrence of new radiological pulmonary abnormalities and an increase in the level of pneumoproteins
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy. * Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer * Postmenopausal women * Radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment * Resistance to treatment with a non-steroidal aromatase inhibitor * Serum platelets ≥ 100x10E9/l * Everolimus dose adjustment is recommended for patients with hepatic impairment (Child-Pugh A/B/C) * Performance status ECOG 0 - 2 (Karnofsky index: 60 - 100) Exclusion Criteria: * Patients with a HER2-overexpressing tumor * Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin). * Patients with a known history of HIV seropositivity or hepatitis B or C * Uncontrolled diabetes mellitus * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome) * Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
References
Publications (1)
- DERIVEDWillemsen AECAB, Tol J, van Erp NP, Jonker MA, de Boer M, Meek B, de Jong PC, van Moorsel C, Gerritsen WR, Grutters JC, van Herpen CML. Prospective Study of Drug-induced Interstitial Lung Disease in Advanced Breast Cancer Patients Receiving Everolimus Plus Exemestane. Target Oncol. 2019 Aug;14(4):441-451. doi: 10.1007/s11523-019-00656-2. PMID 31325105