Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer (PrefHER)

Roche

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms

Treatments: Device: Single-Use Injection Device; Drug: Herceptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01401166

2010-024099-25 (EudraCT Number)

MO22982

Details and patient eligibility

About

This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer. Participants will be randomized to receive either SC Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18 cycles), participants will receive IV or SC Herceptin every 3 weeks.

Enrollment: 488 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed HER2-positive primary breast cancer
• No evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neo-adjuvant or adjuvant)
• Completed neo-adjuvant chemotherapy prior to entry, if received
• At least 8 remaining cycles out of the total 18 planned 3-week cycles, if received IV Herceptin
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria

• History of other malignancy, except for ductal carcinoma in situ of the breast, curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or other curatively treated malignancies of which the participant has been disease-free for at least 5 years
• Inadequate bone marrow function
• Impaired liver function
• Inadequate renal function
• Serious cardiovascular disease
• Human immunodeficiency virus or hepatitis B or C infection
• Prior maximum cumulative dose of doxorubicin greater than (>) 360 milligrams per meter-squared (mg/m^2) or epirubicin >720 mg/m^2 or equivalent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

488 participants in 4 patient groups

Cohort 1: SC (SID) then IV Herceptin

Experimental group

Description:

Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin will be administered via single-use injection device (SID), and during Cycles 5 to 8, IV Herceptin will be given. In the continuation period, participants will receive IV Herceptin for up to 10 remaining cycles. Administration will be performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period will be offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP.

Treatment:

Drug: Herceptin

Device: Single-Use Injection Device

Drug: Herceptin

Device: Single-Use Injection Device

Cohort 1: IV then SC (SID) Herceptin

Experimental group

Description:

Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin will be given, and during Cycles 5 to 8, SC Herceptin will be administered via SID. In the continuation period, participants will receive IV Herceptin for up to 10 remaining cycles. Administration will be performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period will be offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP.

Treatment:

Drug: Herceptin

Device: Single-Use Injection Device

Drug: Herceptin

Device: Single-Use Injection Device

Cohort 2: SC (Vial) then IV Herceptin

Experimental group

Description:

Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin will be administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin will be given. In the continuation period, participants will receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration will be performed by HCP throughout the study.

Treatment:

Drug: Herceptin

Drug: Herceptin

Cohort 2: IV then SC (Vial) Herceptin

Experimental group

Description:

Participants will receive Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin will be given, and during Cycles 5 to 8, SC Herceptin will be administered via handheld syringe using the vial formulation. In the continuation period, participants will receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration will be performed by HCP throughout the study.

Treatment:

Drug: Herceptin

Drug: Herceptin