Overview

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

Status:
Completed
Trial end date:
2019-07-17
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Trastuzumab
Criteria
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