RWD Study in HER2+ mBC Patients in Third-Line Therapy

Exactis Innovation

Status: Completed

Conditions: Breast Cancer Stage IV

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04566458

Exactis-05

Details and patient eligibility

About

This retrospective observational study will collect Canadian real-world data (RWD) from HER2+ metastatic breast cancer (mBC) patients to describe treatment sequences of all therapies received in the metastatic setting, to measure overall survival (OS), progression free survival (PFS), time to next active anti-cancer therapy, and to estimate the health resources utilization (HRU) during third-line therapy.

Full description

The proportion of treatment received during all lines of therapy in the metastatic setting will be described. The 2-year survival rate and median OS with interquartile range (IQR) for third-line therapy will be calculated. HRU data and costs during third-line therapy will be collected.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Male or female patients (≥18 years of age)

Patients with stage IV breast cancer

Patients with HER2+ status in metastatic setting

Patients that received at least two lines of active anti-cancer drugs due to disease progression.

Patients that began third-line therapy prior to October 31, 2018.

Exclusion criteria

Patients treated with an investigational anticancer agent in the ≥ 3rd line setting

Trial design

63 participants in 1 patient group

Single arm

Description:

Her2 positive mBC patients who have received at least 3 lines of treatment in the metastatic setting.

Treatment:

Other: No intervention