Metastatic Breast Cancer
Conditions
Interventions
Group 1: Patients diagnosed with and currently receiving treatment for HER2- mBC.
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must meet all the following criteria to be eligible for inclusion in this study: 1) Females 18 years or older. 2) Have a diagnosis of HER2- mBC (defined as de novo-Stage IV, or recurrent) and have experienced one of the following: i. mTNBC that has been treated with 2+ prior systemic therapies, at least one of them for metastatic disease. ii. HR+/HER2-, defined as (HER2 defined as IHC 0, 1+ or 2+/ISH) mBC that has been treated with endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. 3) Currently receiving treatment for HER2- mBC. 4) Able to access and use a computer, tablet, or smartphone to complete all necessary information for the study. 5) Must be able to understand and sign informed consent form.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: 1 Currently enrolled in a clinical trial for a breast cancer treatment. 2 Patients who were previously enrolled in a clinical trial sponsored by Gilead for a breast cancer treatment. 3 Any other primary cancer diagnosis other than breast cancer (except for non-metastatic, non-melanoma skin) in the 5 years preceding the breast cancer diagnosis. 4 Patients who were previously or currently enrolled in an expanded access program (EAP) for a Gilead product. 5 (Actigraphy component only) Patients who are currently receiving any ADC treatment, including Trodelvy®.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess patient perspectives of AEs, such as the impact of AEs of interest on patient physical functioning, quality of life, psychosocial health, and well-being. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To describe the proportion of patients who experience AEs of interest, from a patient perspective. 2. To assess if AEs of interest impact treatment goals and decision-making preferences, from a patient perspective. 3. To describe how decisions about treatment are made, from patient and physician perspectives. 4. Among the subset of patients taking part in the actigraphy component, use device and patientself-reported data: • To describe activity and sleep • To explore the relationship between quality of life and activity and sleep. | — |
Countries
France, Germany, United States
Contacts
Public ContactJeanna Law
Gilead Sciences, Inc.
Outcome results
None listed