ER Positive, HER2 Negative Breast Cancer Neoplasms Clinical Trial
— IPSOC-mammaOfficial 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:
- 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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 100 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Katholieke Universiteit Leuven - Clinical Pharmacology and Pharmacotherapeutics | Leuven | Brabant |
| Lead Sponsor | Collaborator |
|---|---|
| Katholieke Universiteit Leuven | Novartis |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | one year | No |
| Secondary | 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 | one year | No |
| Secondary | Morisky Medication Adherence Scale (MMAS) | Medication adherence will be assessed, using a standardised questionnaire, after approximately 1, 3, 6 and 12 months of treatment. | one year | No |
| Secondary | 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. | one year | No |
| Secondary | 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. | one year | No |
| Secondary | 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. | one year | No |
| Secondary | 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. | one year | Yes |
| Secondary | 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. | one year | No |
| Secondary | 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. | one year | Yes |