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An Open-label, Randomized, Multicenter Phase III Study in Patients With HER2-positive Metastatic Breast Cancer Responding to First Line Treatment With Intravenous Trastuzumab for at Least 3 Years and Investigating Patient Preference for Subcutaneous Trastuzumab


Phase 3
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

An Open-label, Randomized, Multicenter Phase III Study in Patients With HER2-positive Metastatic Breast Cancer Responding to First Line Treatment With Intravenous Trastuzumab for at Least 3 Years and Investigating Patient Preference for Subcutaneous Trastuzumab


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Histologically or cytologically confirmed HER2-positive metastatic breast cancer

- On treatment with first-line Herceptin IV and free of disease progression for at
least 3 years

- Left ventricular ejection fraction (LVEF) of >/= 50%

- 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 patients with other curatively treated
malignancies who have been disease-free for at least 5 years; patients with previous
ductal carcinoma in situ of the breast are also eligible

- Patients with severe dyspnea at rest or requiring supplementary oxygen therapy

- Serious cardiac illness or medical conditions that would preclude the use of
Herceptin

- Hepatitis B, hepatitis C or HIV infection

- Pregnant or lactating women

- Concurrent enrolment 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, e.g. difficult to control
asthma

- Central nervous system (CNS) metastases unless they have been treated and have been
stable for at least 3 months

- Inadequate organ function

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with preference for either SC or IV route of administration after completing cross-over period (6 cycles) according to patient preference questionnaire (PPQ)

Outcome Time Frame:

approximately 4 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France: ANSM (Agence nationale de sécurité des medicaments et de produits de santé)

Study ID:

ML28589

NCT ID:

NCT01810393

Start Date:

April 2013

Completion Date:

September 2019

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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