A Study to Assess Preference for Subcutaneous Trastuzumab Treatment in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Trastuzumab for at Least 3 Years

Roche

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Trastuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01810393

ML28589

2012-003442-32 (EudraCT Number)

Details and patient eligibility

About

This open-label, randomized, multicenter study will evaluate participant preference for subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with HER2-positive metastatic breast cancer responding to first-line treatment with IV trastuzumab for at least 3 years. Participants will be randomized to receive either 3 cycles (cycle length = 21 days) of trastuzumab SC followed by 3 cycles of trastuzumab IV or 3 cycles of trastuzumab IV followed by 3 cycles of trastuzumab SC. All participants will receive trastuzumab SC for Cycles 7 to 18. Anticipated time on study treatment is 1 year or until disease progression or inacceptable toxicity occurs, whichever comes first.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed HER2-positive metastatic breast cancer
• On treatment with first-line trastuzumab IV and free of disease progression for at least 3 years
• Left ventricular ejection fraction (LVEF) of greater than or equal to (>/=) 50 percent (%)
• Hormonal therapy will be allowed
• Prior use of anti-HER2 therapy will be allowed

Exclusion criteria

• History of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for at least 5 years; participants with previous ductal carcinoma in situ of the breast are also eligible
• Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
• Serious cardiac illness or medical conditions that would preclude the use of trastuzumab
• Hepatitis B, hepatitis C or human immunodeficiency virus infection
• Pregnant or lactating women
• Concurrent enrollment in an other clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
• Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase or the adhesive of the subcutaneous device, or a history of severe allergic or immunological reactions, for example, difficult to control asthma
• Central nervous system metastases, unless they have been treated and have been stable for at least 3 years
• Inadequate organ function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Trastuzumab IV Then Trastuzumab SC

Experimental group

Description:

Participants will receive treatment with Trastuzumab IV for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab SC for the next 3 cycles. Participants will continue receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise participants will continue IV treatment) for a total of 18 cycles of treatment during the study.

Treatment:

Drug: Trastuzumab

Trastuzumab SC Then Trastuzumab IV

Experimental group

Description:

Participants will receive treatment with Trastuzumab SC for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab IV for the next 3 cycles. Participants will continue receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise participants will continue IV treatment) for a total of 18 cycles of treatment during the study.

Treatment:

Drug: Trastuzumab