A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (SafeHER)

Roche

Status and phase: Completed; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: Herceptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01566721

2011-005328-17 (EudraCT Number)

MO28048

Details and patient eligibility

About

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC 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 participants (Cohort B).

Enrollment: 2,577 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 treatment with Herceptin
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Screening left ventricular ejection fraction (LVEF) greater than or equal to (≥) 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, basal cell carcinoma, or curatively treated malignancies (other than breast cancer) where the participant has been disease-free for at least 5 years
• Past history of ductal carcinoma in situ treated with any systemic therapy or with radiation therapy to the ipsilateral breast where invasive cancer subsequently developed
• Metastatic disease
• Inadequate bone marrow, hepatic, or renal function
• Serious cardiac or cardiovascular disease including uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy
• History of severe allergic or immunological reactions, such as difficult-to-control asthma
• Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,577 participants in 2 patient groups

Cohort A: SC Herceptin by Needle/Syringe

Experimental group

Description:

Participants will receive SC Herceptin by an assisted administration using a conventional syringe and needle/vial formulation.

Treatment:

Drug: Herceptin

Cohort B: SC Herceptin by SID

Experimental group

Description:

Participants will receive SC Herceptin with assisted and/or self-administered use of an SID. The first administration will be performed by a trained healthcare professional. If well tolerated and the participant is willing and judged competent to perform self-administration, subsequent administration of SC Herceptin may be performed by the participant.

Treatment:

Drug: Herceptin