Investigating Patient Satisfaction With Oral Anti-cancer Treatment in Patients With Hormone-receptor Positive, HER2-receptor Negative, Advanced Breast Cancer (IPSOC-mamma)

Catholic University (KU) of Leuven

Status: Unknown

Conditions: ER Positive, HER2 Negative Breast Cancer Neoplasms

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02875951

VF/2014/03

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

ER positive, HER2 negative breast cancer patients

Description:

Postmenopausal patients with hormone receptor positive, HER2 receptor negative breast cancer