Clinical trial NCT02875951: Investigating Patient Satisfaction With Oral Anti-cancer Treatment in Patients With Hormone-receptor Positive, HER2-receptor Negative, Advanced Breast Cancer
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ER Positive, HER2 Negative Breast Cancer Neoplasms
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2016-08-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Medication adherence
timeFrame: one year
Secondary outcomes:
measure: Patient Satisfaction with Cancer Treatment Education (Ps-CaTE)
timeFrame: one year
measure: Morisky Medication Adherence Scale (MMAS)
timeFrame: one year
measure: Cancer Therapy Satisfaction Questionnaire (CTSQ)
timeFrame: one year
measure: Functional Assessment of Cancer Therapy - for patients with breast cancer (FACT-B)
timeFrame: one year
measure: Tumor status evaluation
timeFrame: one year
measure: Tumor status evaluation
timeFrame: one year
measure: Performance status of the patient
timeFrame: one year
measure: Toxicity of treatment
timeFrame: one year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven - Clinical Pharmacology and Pharmacotherapeutics
state: Brabant
Study officials:
References: