Overview

This trial is active, not recruiting.

Condition breast cancer
Sponsor Hoffmann-La Roche
Start date November 2013
End date July 2016
Trial size 985 participants
Trial identifier NCT01959386, ML28759

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Pathological complete response (pCR) rate (for patients treated in the neo-adjuvant setting)
time frame: approximately 1 year
Disease-free survival (DSF) rate after 2 years (for patients treated in the adjuvant setting)
time frame: 2 years

Secondary Outcomes

Measure
Safety: Incidence of adverse events
time frame: up to 3 years
Quality of life: EORTC QLQ-C30/QLQ-BR23 questionnaires
time frame: approximately 1 year
Herceptin dose/treatment schedule/administration
time frame: approximately 1 year
Concomitant chemotherapy/treatment/intervention
time frame: approximately 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title CLINICAL PRACTICE SURVEILLANCE OF THE USE OF HERCEPTIN SUBCUTANEOUS IN PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER (HerSCin)
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.