ER Positive, HER2 Negative Breast Cancer NeoplasmsIPSOC-mammaNCT02875951
Investigating Patient Satisfaction With Oral Anti-cancer Treatment in Patients With Hormone-receptor Positive, HER2-receptor Negative, Advanced Breast Cancer
An observational study of ER Positive, HER2 Negative Breast Cancer Neoplasms, run by KU Leuven at 1 site in Belgium.
Trial summary
A prospective, non-interventional, non-controlled multicenter observational study to evaluate aspects of pharmaceutical care and the treatment of postmenopausal patients with hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with everolimus and exemestane. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- ER Positive, HER2 Negative Breast Cancer Neoplasms
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2015to Dec 2017
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal women with hormone-receptor positive, HER2 receptor negative advanced breast cancer, without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor, starting with a combination treatment of everolimus \& exemestane
Who may be able to join
- Postmenopausal women, 18 years or older
- Signed written informed consent
- Patient can be contacted by phone and/or e-mail
- HR+, HER2- advanced or metastatic breast cancer
- Recurrence or progression following a non-steroidal aromatase inhibitor
- Able to swallow and retain oral medication
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
Who cannot join
- Patients who are not able to understand Dutch or French
- Symptomatic visceral metastatic disease
- Patients who have taken an investigational drug within 28 days or 5 half-lives, whichever is shorter, prior to recruitment
- Current use of a prohibited medication as described in the SPC
- Any serious or unstable pre-existing medical conditions, psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedure
- Hypersensitivity to the active substances or to any of the excipients
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Katholieke Universiteit Leuven - Clinical Pharmacology and Pharmacotherapeutics
Leuven, Brabant, 3000
Sandra De Coster, pharmacist, +3216377180, sandra.decoster@pharm.kuleuven.be
Veerle Foulon, professor, +3216323464, veerle.foulon@pharm.kuleuven.be
About this study
Official title: Prospective, Non-interventional, Non-controlled Multicenter Observational Study to Evaluate Aspects of Pharmaceutical Care and the Treatment of Postmenopausal Patients With Hormone-receptor Positive, HER2-receptor Negative, Advanced Breast Cancer Treated With Everolimus and Exemestane.
A prospective, non-interventional, non-controlled multicenter observational study to evaluate aspects of pharmaceutical care and the treatment of postmenopausal patients with hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with everolimus and exemestane.
The main objective of the study is to evaluate medication adherence in postmenopausal, hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with a combination of everolimus and exemestane. Additionally, other aspects of the pharmacotherapy, with focus on the patient perspective, will be investigated:
Read more
- Patient satisfaction with treatment information
- Patient satisfaction with treatment
- Health-related quality of life
- Treatment efficacy
- Treatment-related toxicity
- Patient follow-up by the oncologic team/general practitioner and or specialized home nurses
This study should reveal information necessary for the development of pharmacotherapeutic care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug over a long period.
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 |
|---|---|---|
| ER positive, HER2 negative breast cancer patients | Postmenopausal patients with hormone receptor positive, HER2 receptor negative breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
At the first visit patients will receive their anti-cancer medication by the hospital in two separate pill boxes which electronically record openings cf. Medication Event Monitoring System (MEMS®, Aardex). The recorded information in these chips will be read in the hospital pharmacy each time the patient gets new capsules. This information is strictly confidential and can only be consulted by the research team at the KULeuven.
Measured: one year
Secondary outcomes (8)
Patient Satisfaction with Cancer Treatment Education (Ps-CaTE)
Satisfaction with cancer treatment information will be assessed, using a standardised questionnaire at the start of the treatment and after approximately 1, 3, 6 and 12 months of treatment
Measured: one year
Morisky Medication Adherence Scale (MMAS)
Medication adherence will be assessed, using a standardised questionnaire, after approximately 1, 3, 6 and 12 months of treatment.
Measured: one year
Cancer Therapy Satisfaction Questionnaire (CTSQ)
Satisfaction with cancer treatment will be assessed, using a standardised questionnaire, after approximately 1, 3, 6 and 12 months of treatment.
Measured: one year
Functional Assessment of Cancer Therapy - for patients with breast cancer (FACT-B)
Health-related quality of life will be assessed, using a standardised questionnaire, at the start of the treatment and after approximately 1, 3, 6 and 12 months of treatment.
Measured: one year
Tumor status evaluation
Tumor status evaluation of the patient will be assessed by the treating oncologist by CA15-3 \& CEA markers at the start of the study and after 1, 3, 6 and 12 months of treatment.
Measured: one year
Tumor status evaluation
Tumor status evaluation of the patient will be assessed by the treating oncologist by RECIST criteria after 1, 3, 6 and 12 months of treatment.
Measured: one year
Performance status of the patient
Performance status of the patient will be assessed by the treating oncologist by ECOG criteria at the start of the study and after 1, 3, 6 and 12 months of treatment.
Measured: one year
Toxicity of treatment
Severity of adverse events and relation to the treatment will be assessed by the treating oncologist, based on CTC-NCI 4.0, after 1, 3, 6 and 12 months of treatment.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ER Positive, HER2 Negative Breast Cancer NeoplasmsStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Sandra De Coster, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875951
- Sponsor's protocol ID
- VF/2014/03
- Acronym
- IPSOC-mamma
- Status last verified
- Aug 2016
- First submitted
- 18 Jul 2016
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-interventional, Non-controlled Multicenter Observational Study to Evaluate Aspects of Pharmaceutical Care and the Treatment of Postmenopausal Patients With Hormone-receptor Positive, HER2-receptor Negative, Advanced Breast Cancer Treated With Everolimus and Exemestane.
- ClinicalTrials.gov ID
- NCT02875951
- Acronym / sponsor ID
- IPSOC-mamma / VF/2014/03
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Sep 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Aug 2016 (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.
A prospective, non-interventional, non-controlled multicenter observational study to evaluate aspects of pharmaceutical care and the treatment of postmenopausal patients with hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with everolimus and exemestane.
The main objective of the study is to evaluate medication adherence in postmenopausal, hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with a combination of everolimus and exemestane. Additionally, other aspects of the pharmacotherapy, with focus on the patient perspective, will be investigated:
- Patient satisfaction with treatment information
- Patient satisfaction with treatment
- Health-related quality of life
- Treatment efficacy
- Treatment-related toxicity
- Patient follow-up by the oncologic team/general practitioner and or specialized home nurses
This study should reveal information necessary for the development of pharmacotherapeutic care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug over a long period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ER positive, HER2 negative breast cancer patients | – | –Postmenopausal patients with hormone receptor positive, HER2 receptor negative breast cancer |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women with hormone-receptor positive, HER2 receptor negative advanced breast cancer, without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor, starting with a combination treatment of everolimus \& exemestane
Key inclusion criteria (7 listed)
- Postmenopausal women, 18 years or older
- Signed written informed consent
- Patient can be contacted by phone and/or e-mail
- HR+, HER2- advanced or metastatic breast cancer
- Recurrence or progression following a non-steroidal aromatase inhibitor
Key exclusion criteria (6 listed)
- Patients who are not able to understand Dutch or French
- Symptomatic visceral metastatic disease
- Patients who have taken an investigational drug within 28 days or 5 half-lives, whichever is shorter, prior to recruitment
- Current use of a prohibited medication as described in the SPC
- Any serious or unstable pre-existing medical conditions, psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedure
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
Medication adherence
Time frame: one year
At the first visit patients will receive their anti-cancer medication by the hospital in two separate pill boxes which electronically record openings cf. Medication Event Monitoring System (MEMS®, Aardex). The recorded information in these chips will be read in the hospital pharmacy each time the patient gets new capsules. This information is strictly confidential and can only be consulted by the research team at the KULeuven.
8 secondary outcomes
Patient Satisfaction with Cancer Treatment Education (Ps-CaTE)
Time frame: one year
Morisky Medication Adherence Scale (MMAS)
Time frame: one year
Cancer Therapy Satisfaction Questionnaire (CTSQ)
Time frame: one year
Functional Assessment of Cancer Therapy - for patients with breast cancer (FACT-B)
Time frame: one year
Tumor status evaluation
Time frame: one year
Tumor status evaluation
Time frame: one year
Performance status of the patient
Time frame: one year
Toxicity of treatment
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ER Positive, HER2 Negative Breast Cancer Neoplasms, run by KU Leuven at 1 site in Belgium.
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 7 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: status not confirmed, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra De Coster, pharmacist (+3216377180, sandra.decoster@pharm.kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2016.