A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 10 May 2021
• Main ID: NCT01566721
• Date of registration: 22/03/2012
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer SafeHER
• Scientific title: A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer
• Date of first enrolment: May 17, 2012
• Target sample size: 2577
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01566721
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Albania, Algeria, Argentina, Australia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Czechia, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Korea, Republic of, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically confirmed early invasive HER2-positive carcinoma of the breast with no
evidence of residual, locally recurrent, or metastatic disease and defined as clinical
Stage I to IIIC that is eligible for treatment with Herceptin

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Screening left ventricular ejection fraction (LVEF) greater than or equal to (=) 55%

Exclusion Criteria:

- Previous neoadjuvant or adjuvant breast cancer treatment with an approved or
investigational anti-HER2 agent

- History of other malignancy except for curatively treated carcinoma in situ of the
cervix, basal cell carcinoma, or curatively treated malignancies (other than breast
cancer) where the participant has been disease-free for at least 5 years

- Past history of ductal carcinoma in situ treated with any systemic therapy or with
radiation therapy to the ipsilateral breast where invasive cancer subsequently
developed

- Metastatic disease

- Inadequate bone marrow, hepatic, or renal function

- Serious cardiac or cardiovascular disease including uncontrolled hypertension or
history of hypertensive crisis or hypertensive encephalopathy

- History of severe allergic or immunological reactions, such as difficult-to-control
asthma

- Pregnant or lactating women



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

Health Condition(s) or Problem(s) studied

Breast Neoplasms

Intervention(s)

Drug: Herceptin

Primary Outcome(s)

Percentage of Participants Who Received Concomitant Non-Cancer Therapy [Time Frame: From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)]

Percentage of Participants by Total Number of Herceptin Cycles Received [Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)]

Number of Herceptin Cycles Received [Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)]

Percentage of Participants With Treatment Interruption Due to an AE [Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)]

Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period [Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)]

Percentage of Participants Who Received Concomitant Cancer Therapy [Time Frame: From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)]

Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period [Time Frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)]

Secondary Outcome(s)

Percentage of Participants by Item Response to SID Satisfaction Questionnaire [Time Frame: Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)]

Overall Survival Rate [Time Frame: From Baseline to Time of Event (Up to Approximately 6 Years)]

Percentage of Participants Who Died During the Safety Follow-up Period [Time Frame: From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years)]

Disease-Free Survival Rate [Time Frame: From Baseline to time of event (up to approximately 8 years)]

Percentage of Participants Who Died by Data Cutoff of 10 March 2015 [Time Frame: From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)]

Secondary ID(s)

2011-005328-17

MO28048

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01566721