ER Positive, HER2 Negative Breast Cancer Neoplasms
Conditions
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.
Interventions
None listed
Sponsors
Novartis
KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction with Cancer Treatment Education (Ps-CaTE) | one year | 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 |
| Morisky Medication Adherence Scale (MMAS) | one year | Medication adherence will be assessed, using a standardised questionnaire, after approximately 1, 3, 6 and 12 months of treatment. |
| Cancer Therapy Satisfaction Questionnaire (CTSQ) | one year | Satisfaction with cancer treatment will be assessed, using a standardised questionnaire, after approximately 1, 3, 6 and 12 months of treatment. |
| Toxicity of treatment | one year | 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. |
| Tumor status evaluation | one year | 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. |
| Performance status of the patient | one year | 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. |
| Functional Assessment of Cancer Therapy - for patients with breast cancer (FACT-B) | one year | 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. |
Countries
Belgium
Contacts
Primary ContactSandra De Coster, pharmacist
Backup ContactVeerle Foulon, professor
Outcome results
None listed