Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01401166
• Date of registration: 22/07/2011
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer PrefHER
• Scientific title: A Randomized, Multi-Center 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)
• Date of first enrolment: October 2011
• Target sample size: 488
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01401166
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada, Denmark, France, Germany, Italy, Poland, Russian Federation, Spain, Sweden, Switzerland, Turkey, United Kingdom

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically confirmed HER2-positive primary breast cancer

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

- Completed neo-adjuvant chemotherapy prior to entry, if received

- At least 8 remaining cycles out of the total 18 planned 3-week cycles, if received IV
Herceptin

- 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, basal cell carcinoma, or other
curatively treated malignancies of which the participant has been disease-free for at
least 5 years

- Inadequate bone marrow function

- Impaired liver function

- Inadequate renal function

- Serious cardiovascular disease

- Human immunodeficiency virus or hepatitis B or C infection

- Prior maximum cumulative dose of doxorubicin greater than (>) 360 milligrams per
meter-squared (mg/m^2) or epirubicin >720 mg/m^2 or equivalent



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Neoplasms

Intervention(s)

Device: Single-Use Injection Device

Drug: Herceptin

Primary Outcome(s)

Percentage of Participants by Preferred Method of Drug Administration [Time Frame: Week 24]

Secondary Outcome(s)

Percentage of Participants With an Event-Free Survival (EFS) Event [Time Frame: From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)]

Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire [Time Frame: Immediately following first self-administration of SC Herceptin via SID (once during Weeks 25 to 52)]

3-Year EFS Rate [Time Frame: Year 3]

Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies [Time Frame: Baseline, pre-dose (0 hours) during Cycle 5 (cycle length of 3 weeks)]

Percentage of HCPs by Most Satisfied Method of Drug Administration [Time Frame: Week 24]

Percentage of HCPs by Time Required to Perform Each Method of Drug Administration [Time Frame: Week 24]

Duration of EFS According to Kaplan-Meier Estimate [Time Frame: From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)]

Secondary ID(s)

2010-024099-25

MO22982

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/06/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01401166