HerSCin: An Observational Study of Herceptin (Trastuzumab) Subcutaneous in Patients With HER2-Positive Early Beast Cancer
Conditions
Breast Cancer
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
This observational study will evaluate the efficacy, safety, tolerability and patient reported quality of life of Herceptin (trastuzumab) subcutaneous therapy in patients with HER2-positive early breast cancer in routine clinical practice. Data from eligible patients will be collected for the duration of their treatment (approximately 1 year) and for 1-2 years of follow-up.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Female or male adult patient; >/= 18 years of age

- Histologically confirmed adenocarcinoma of the breast

- HER2-positive tumor

- Eligible for neo-adjuvant or adjuvant treatment with Herceptin SC according to the judgement of the physician Note: As of patient recruitment (date of patient informed consent), retrospective documentation is allowed but limited to up to 9 weeks after initial start of therapy with Herceptin SC

Exclusion Criteria:

- Contraindications according to the Summary of Product Characteristics of Herceptin SC

- Pregnant and breastfeeding women
Location
Mainz, Germany
Status: Recruiting
Start Date
November 2013
Completion Date
September 2018
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page