Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments trastuzumab [herceptin]
Phase phase 3
Target HER2
Sponsor Hoffmann-La Roche
Start date May 2012
End date March 2020
Trial size 2578 participants
Trial identifier NCT01566721, 2011-005328-17, MO28048

Summary

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted- and self-administered subcutaneous Herceptin (trastuzumab) as adjuvant therapy in patients with early HER2-positive breast cancer whose tumour has been excised. Patients will receive Herceptin 600 mg subcutaneously every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle (vial formulation, Cohort A) or with assisted- and self-administration using a single-use injection device (SID) in selected patients (Cohort B). Anticipated time on study treatment is up to 1 year.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
trastuzumab [herceptin]
600 mg sc by assisted administration using the vial formulation, into thigh, on Day 1 of each 3-week cycle, 18 cycles
(Experimental)
trastuzumab [herceptin]
600 mg sc by single-use injection device (SID) and by self-administration in select patients, into thigh, on Day 1 of each 3-week cycle, 18 cycles

Primary Outcomes

Measure
Safety: Incidence of adverse events
time frame: approximately 8 years

Secondary Outcomes

Measure
Disease-free survival
time frame: approximately 8 years
Overall survival
time frame: approximately 8 years
Patient satisfaction with trastuzumab SC using the single-use injection device (SID): SID satisfaction questionnaire (patients in cohort B who went on to self-administration of the study drug)
time frame: approximately 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult male or female patients, >/= 18 years of age - Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent or metastatic disease and defined as clinical stage I to IIIC that is eligible for adjuvant treatment with trastuzumab - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Screening left ventricular ejection fraction (LVEF) >/= 55% Exclusion Criteria: - Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent - History of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively treated malignancies, other than breast cancer, who have been disease-free for at least 5 years - Past history of ductal carcinoma in situ that has been treated with any systemic therapy or with radiation therapy to the ipsilateral breast where the invasive cancer subsequently develops - Metastatic disease - Inadequate bone marrow, hepatic or renal function - Serious cardiac or cardiovascular disease - Uncontrolled hypertension, or history of hypertensive crisis or hypertensive encephalopathy - History of severe allergic or immunological reactions, e.g. difficult to control asthma - Pregnant or lactating women

Additional Information

Official title A PHASE III PROSPECTIVE, TWO-COHORT NON-RANDOMIZED, MULTI-CENTRE, MULTINATIONAL, OPEN LABEL STUDY TO ASSESS THE SAFETY OF ASSISTED- AND SELF-ADMINISTERED SUBCUTANEOUS TRASTUZUMAB AS THERAPY IN PATIENTS WITH OPERABLE HER2-POSITIVE EARLY BREAST CANCER [SafeHer Study]
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.