An Observational Study of Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer Treated With Herceptin (Trastuzumab) in 1st Line and Without Progression For 3 Years

Roche

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Trastuzumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01480674

ML23001

Details and patient eligibility

About

This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years. Patients will be followed prospectively for one year.

Enrollment: 160 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients, >/= 18 years of age
• HER2-positive metastatic breast cancer or locally advanced breast cancer
• Systemic treatment included Herceptin as 1st line therapy
• Without progression for at least 3 years after the beginning of Herceptin treatment
• Alive or not alive and treated or not treated with Herceptin at the time of inclusion

Exclusion criteria

• Disease progression <3 years after beginning 1st-line therapy with Herceptin

Trial design

160 participants in 1 patient group

Trastuzumab

Description:

Eligible participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.

Treatment:

Drug: Trastuzumab