Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry Study (ESTHER)

Roche

Status: Completed

Conditions: Breast Cancer

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02393924

ML29659

Details and patient eligibility

About

This disease registry is a prospective, multicenter non-interventional study designed to observe the different anticancer treatment regimens and their sequencing throughout the course of the disease in participants with unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) and to describe the clinical outcome for each treatment regimen measured as progression-free survival.

Enrollment: 311 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Initially diagnosed with HER2-positive unresectable LABC or mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time
• Able and willing to provide written informed consent and to comply with the study protocol

Exclusion criteria

• There are no exclusion criteria for entry into this study

Trial design

311 participants in 1 patient group

Participants With HER2-Positive Breast Cancer

Description:

Enrolled participants will receive treatment and clinical assessments for their HER2-positive unresectable LABC/mBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site. Participants will be followed until death, withdrawal of consent or study termination, whichever occurs first. Study protocol does not specify any particular drug or treatment regimen.

Treatment:

Other: No intervention