An Observational Study Evaluating the Productivity and Health-Related Quality of Life of People With HER2 Positive Breast Cancer

Roche

Status: Completed

Conditions: Breast Neoplasms

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT03099200

ML30098

Details and patient eligibility

About

The purpose of this study is to compare productivity (in terms of work or daily activity) and generic and disease-specific health-related quality of life of participants with HER2 positive early breast cancer currently receiving adjuvant treatment (with chemotherapy and/or targeted HER2 therapy), with participants who have completed adjuvant parenteral therapy, and participants with HER2 positive metastatic breast cancer.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with early stage or metastatic (Stage IV) HER2-positive breast cancer (confirmed by the study site physician). [HER2-positive is defined as ImmunoHistoChemistry (IHC3+) and/or in situ hybridization (ISH) ≥2.0]
• Able to provide written, informed consent.
• Early Stage Breast Cancer (eBC) patients must have received at least 1 cycle of adjuvant anti-cancer therapy following surgery; metastatic breast cancer (mBC) patients must have received at least 1 cycle of treatment for their metastatic disease.

Exclusion criteria

• Unwilling or unable to consent.
• Unable to complete written quality of life questionnaires
• Partcipants with Eastern Cooperative Oncology Group (ECOG) Performance Status ≥3

Trial design

300 participants in 3 patient groups

Cohort 1

Description:

Participants with early breast cancer currently undergoing treatment (either chemotherapy and targeted HER2 therapy OR targeted HER2 therapy alone) will be observed.

Treatment:

Other: No Intervention

Cohort 2

Description:

Participants with early breast cancer who have completed treatment and are in disease-free survival (i.e. no longer receiving loco-regional treatment, chemotherapy or targeted HER2 therapy; participants may still be receiving hormone therapy) will be observed.

Treatment:

Other: No Intervention

Cohort 3

Description:

Participants receiving treatment for metastatic breast cancer will be observed.

Treatment:

Other: No Intervention