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A Randomized, Multi-centre Cross-over Study to Evaluate Patient Preference and Health Care Professional (HCP) Satisfaction With Subcutaneous (SC) Administration of Trastuzumab in HER2-positive Early Breast Cancer (EBC).


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Randomized, Multi-centre Cross-over Study to Evaluate Patient Preference and Health Care Professional (HCP) Satisfaction With Subcutaneous (SC) Administration of Trastuzumab in HER2-positive Early Breast Cancer (EBC).


Inclusion Criteria:



- Female patients, >/= 18 years of age

- HER2-positive breast cancer

- No evidence of residual, locally recurrent or metastatic disease after completion of
surgery and chemotherapy (neoadjuvant or adjuvant)

- All adjuvant chemotherapy must be completed, adjuvant radiotherapy may be ongoing

- Patients who have already received IV Herceptin must have at least 10 out of the
total planned 18 3-week cycles remaining

- 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 or basal cell carcinoma, or other
curatively treated malignancies that have been disease-free for at least 5 years

- Inadequate bone marrow function

- Impaired liver function

- Inadequate renal function

- Serious cardio-vascular disease

- HIV or hepatitis B (HBV) or C (HCV) infection

- Prior maximum cumulative dose of doxorubicin > 360 mg/m2 or epirubicin > 720 mg/m2 or
equivalent

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 indicating an overall preference for either the subcutaneous (SC) or the intravenous (IV) route of administration

Outcome Time Frame:

Week 22

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Italy: Ministry of Health

Study ID:

MO22982

NCT ID:

NCT01401166

Start Date:

October 2011

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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