Overview

This trial is active, not recruiting.

Condition breast cancer
Sponsor Hoffmann-La Roche
Start date January 2015
End date January 2018
Trial size 510 participants
Trial identifier NCT02286362, ML28983

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
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)
time frame: approximately 13 months

Secondary Outcomes

Measure
Demographic data
time frame: Up to 12 months
Number of modalities regarding dose and injection site of Herceptin SC administration
time frame: Up to 12 months
Patient-reported outcome: Quality of Life using the EORTC QLQ-C30 questionnaire
time frame: Every 3 months, up to 12 months

Eligibility Criteria

Female participants at least 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.