Breast Cancer
Conditions
Brief summary
This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice. Patients with HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with Herceptin SC in routine clinical practice use are eligible to participate. The total study duration is anticipated to be 38 months.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged \>/= 18 years * Patients with HER2-positive early breast cancer who according to national guidelines are eligible for neoadjuvant or adjuvant HER2+ treatment * Patients for whom the investigator has decided to start a treatment with Herceptin SC * Trastuzumab treatment naive or non-naive (previously intravenous treatment) * Informed consent
Exclusion criteria
* Patients previously treated with Herceptin SC treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (composite outcome measure): Incidence, nature, and severity according to NCI-CTCAE v. 4.0 of: adverse events (AEs), serious AEs, grade >/= 3 AEs, non-serious adverse drug reaction or causality unknown, AESI (congestive heart failure) | approximately 13 months |
Secondary
| Measure | Time frame |
|---|---|
| Demographic data | Up to 12 months |
| Number of modalities regarding dose and injection site of Herceptin SC administration | Up to 12 months |
| Patient-reported outcome: Quality of Life using the EORTC QLQ-C30 questionnaire | Every 3 months, up to 12 months |
Countries
France
Outcome results
None listed