A Study of Participant Satisfaction and Safety With Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01964391
• Date of registration: 08/10/2013
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Participant Satisfaction and Safety With Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer
• Scientific title: An Open-Label, Multinational, Multicenter, Phase IIIb Study With Subcutaneous Administration of Trastuzumab in Patients With HER2-Positive Early Breast Cancer to Evaluate Patient Satisfaction
• Date of first enrolment: February 21, 2014
• Target sample size: 174
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01964391
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Algeria, Morocco, Saudi Arabia, Tunisia, Turkey

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

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

- Hormonal therapy will be allowed as per institutional guidelines

- Prior use of anti-HER2 therapy will be allowed, except for early breast cancer
participants in the neo-adjuvant setting

- Left ventricular ejection fraction (LVEF) of greater than or equal to (>=) 55 percent
(%) measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan
prior to first dose of trastuzumab, or, for those who were receiving trastuzumab when
beginning the study, documented results within an acceptable limit from a cardiac
assessment within 3 months prior to enrollment

- HER2-positive disease immunohistochemistry 3 plus (IHC3+) or in situ hybridization
(ISH) positive as determined in a local laboratory that is experienced/certified in
HER2-expression testing using an accurate and validated assay

- Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast

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

- Use of concurrent curative radiotherapy will be permitted

Exclusion Criteria:

- History of other malignancy which could affect compliance with the protocol or
interpretation of results. Participants with 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, are eligible

- Severe dyspnea at rest or requirement for supplementary oxygen therapy

- Other concurrent serious diseases that may interfere with planned treatment, including
severe pulmonary conditions/illness

- Serious cardiac illness or medical conditions that would preclude the use of
trastuzumab, specifically: history of documented congestive heart failure (CHF),
high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically
significant valvular disease, evidence of transmural infarction on electrocardiogram
(ECG), diagnosed poorly controlled hypertension

- Known infection with human immunodeficiency virus (HIV), active hepatitis B virus
(HBV) or hepatitis C virus (HCV)

- Pregnant or lactating women

- Concurrent enrollment in another clinical trial using an investigational anti-cancer
treatment, including hormonal therapy, bisphosphonate 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, or a history of severe allergic or immunological reactions, e.g. difficult
to control asthma

- Inadequate bone marrow, hepatic or renal function



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

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Carboplatin

Drug: Cyclophosphamide

Drug: Docetaxel

Drug: Paclitaxel

Drug: Trastuzumab

Drug: Doxorubicin

Drug: Neo-adjuvant chemotherapy

Primary Outcome(s)

Participant Satisfaction Questionnaire Score [Time Frame: Week 52]

Percentage of Participants with Adverse Events (AEs) [Time Frame: Baseline up to 4.5 years]

Secondary Outcome(s)

Disease-Free Survival (DFS) [Time Frame: Baseline until first documented disease or death, whichever comes first (up to 4.5 years)]

Duration of Treatment, Follow-up, and Safety Observation [Time Frame: Baseline up to 4.5 years]

Total Daily Dose of Trastuzumab [Time Frame: Baseline up to 1 year]

Healthcare Professional Experience and Satisfaction Questionnaire Score [Time Frame: Week 52]

Number of Days on Trastuzumab Treatment [Time Frame: Baseline up to 1 year]

Cumulative Dose of Trastuzumab [Time Frame: Baseline up to 1 year]

Overall Survival (OS) [Time Frame: Baseline until death from any cause (up to 4.5 years)]

Secondary ID(s)

ML28851

Source(s) of Monetary Support

Please refer to primary and secondary sponsors