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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
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

NCT01810393

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Breast Cancer

Interventions: Trastuzumab

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (61)
  • Agen, France
  • Amiens, France
  • Angers, France
  • Arras, France
  • Avignon, France
  • Bayonne, France
  • Besançon, France
  • Bordeaux, France
  • Bourg-en-Bresse, France
  • Brest, France
  • Brest, France
  • Caen, France
  • Clermont-Ferrand, France
  • Clermont-Ferrand, France
  • Créteil, France
  • Dechy, France
  • Dijon, France
  • La Roche-sur-Yon, France
  • Le Coudray, France
  • Le Mans, France
  • Lille, France
  • Lille, France
  • Lorient, France
  • Lyon, France
  • Lyon, France
  • Lyon, France
  • Marseille, France
  • Melz-sur-Seine, France
  • Metz, France
  • Montpellier, France
  • + 31 more on CT.gov