Breast NeoplasmsPREVENTNCT01978171
Prediction of Everolimus-induced Interstitial Lung Disease
An observational study of Breast Neoplasms, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 27 participants
- Where
- 2 sitesNetherlands
- Study dates
- May 2014to 15 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Antonius Ziekenhuis
Nieuwegein
Radboud university medical center
Nijmegen
About this study
Official title: Prediction of Everolimus-induced Interstitial Lung Disease in Breast Cancer Patients; Maximizing Efficacy by Reducing Toxicity
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.
Read the detailed description
In this study the investigators will prospectively investigate pulmonary adverse events during treatment with everolimus. The investigators will distinguish the following everolimus-induced pulmonary adverse events: pulmonary infection, everolimus-induced airway disease and everolimus-induced interstitial lung disease (ILD). The investigators will investigate the predictive value of pneumoproteins, everolimus exposure, pulmonary function tests, four distinct radiological patterns, baseline patient characteristics and the development of skin toxicity or oral mucositis for the development and severity of everolimus-induced ILD.
- Conditions
- Breast Neoplasms
- Keywords
- breast neoplasms, everolimus, interstitial lung disease, pneumonitis
- Medical subject headings
- Breast Neoplasms, Lung Diseases, Interstitial, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| breast cancer patients | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictive factors of everolimus-induced ILD
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
Measured: six months
Secondary outcomes (3)
temporal relation pneumoproteins and ILD
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
Measured: six months
pathophysiology of everolimus-induced ILD
Investigate which immunological changes (cytokines, T-cells, dendritic cells) are observed in peripheral blood, skin biopsies and bronchoalveolar lavage fluid of patients with everolimus-induced toxicity
Measured: six months
relation ILD and exposure and outcome
Define the correlation between everolimus-induced ILD on the one hand and everolimus exposure (as per AUC0-24h) on day 14) and outcome (time to progression, as determined by treating physician) on the other hand
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startMay 2014
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carla van Herpen, MD, PhD, Principal investigator, Radboud university medical center, department of medical oncologyNielka van Erp, PharmD, PhD, Principal investigator, Radboud university medical center, department of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978171
- Sponsor's protocol ID
- UMCNONCO201302
- Acronym
- PREVENT
- Status last verified
- Sep 2017
- First submitted
- 31 Oct 2013
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Willemsen 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.
PubMed 31325105
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Everolimus-induced Interstitial Lung Disease in Breast Cancer Patients; Maximizing Efficacy by Reducing Toxicity
- ClinicalTrials.gov ID
- NCT01978171
- Acronym / sponsor ID
- PREVENT / UMCNONCO201302
- Conditions
- Breast Neoplasms
- Keywords
- breast neoplasms, everolimus, interstitial lung disease, pneumonitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study the investigators will prospectively investigate pulmonary adverse events during treatment with everolimus. The investigators will distinguish the following everolimus-induced pulmonary adverse events: pulmonary infection, everolimus-induced airway disease and everolimus-induced interstitial lung disease (ILD). The investigators will investigate the predictive value of pneumoproteins, everolimus exposure, pulmonary function tests, four distinct radiological patterns, baseline patient characteristics and the development of skin toxicity or oral mucositis for the development and severity of everolimus-induced ILD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast cancer patients | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
predictive factors of everolimus-induced ILD
Time frame: six months
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
3 secondary outcomes
temporal relation pneumoproteins and ILD
Time frame: six months
pathophysiology of everolimus-induced ILD
Time frame: six months
relation ILD and exposure and outcome
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Derived from this study: PubMed 31325105Willemsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla van Herpen, MD, PhD principal investigator
Radboud university medical center, department of medical oncology
Nielka van Erp, PharmD, PhD principal investigator
Radboud university medical center, department of Pharmacy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictive factors of everolimus-induced ILD (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01978171, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.