A Study of Trastuzumab Subcutaneous in Participants With Human Epidermal Growth Factor Receptor-2 (HER2) Positive Early Breast Cancer (HerSCin)

Roche

Status: Completed

Conditions: Breast Neoplasms

Treatments: Drug: Trastuzumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01959386

ML28759

Details and patient eligibility

About

This observational study will evaluate the efficacy, safety, tolerability and participant reported quality of life of trastuzumab (Herceptin) subcutaneous (SC) therapy in participants with HER2-positive early breast cancer in routine clinical practice. Data from eligible participants will be collected for the duration of their treatment (approximately 1 year) and for 1-2 years of follow-up.

Enrollment: 1,006 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed adenocarcinoma of the breast
• HER2-positive tumor
• Eligible for neo-adjuvant or adjuvant treatment with trastuzumab SC according to the judgement of the physician Note: As of participant recruitment (date of participant informed consent), retrospective documentation is allowed but limited to up to 9 weeks after initial start of therapy with trastuzumab SC

Exclusion criteria

• Contraindications according to the Summary of Product Characteristics of Herceptin SC
• Pregnant and breastfeeding women

Trial design

1,006 participants in 1 patient group

HER2 Positive Breast Cancer Participants

Description:

Participants with HER2 positive tumors who are considered for treatment with trastuzumab SC according to the judgement of physician and according to the actual summary of product characteristics will be observed for a period of approximately 1 year and will be followed for an additional 2 years.

Treatment:

Drug: Trastuzumab