Clinical trial NCT01964391: 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Phase IIIb, open-label, multinational, multicenter study will evaluate the participant's satisfaction and safety with subcutaneously administered trastuzumab in participants with HER2-positive early breast cancer. Participants will receive trastuzumab 600 milligrams (mg) administered subcutaneously every 3 weeks in the adjuvant or neo-adjuvant plus adjuvant setting for 18 cycles (1 year), unless disease progression or unacceptable toxicity occurs. The trastuzumab regimen could include mono- and/or combination therapy.


Eligibility 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

Primary outcomes:
measure: Participant Satisfaction Questionnaire Score
timeFrame: Week 52
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Baseline up to 4.5 years
Secondary outcomes:
measure: Healthcare Professional Experience and Satisfaction Questionnaire Score
timeFrame: Week 52
measure: Overall Survival (OS)
timeFrame: Baseline until death from any cause (up to 4.5 years)
measure: Disease-Free Survival (DFS)
timeFrame: Baseline until first documented disease or death, whichever comes first (up to 4.5 years)
measure: Number of Days on Trastuzumab Treatment
timeFrame: Baseline up to 1 year
measure: Total Daily Dose of Trastuzumab
timeFrame: Baseline up to 1 year
measure: Cumulative Dose of Trastuzumab
timeFrame: Baseline up to 1 year
measure: Duration of Treatment, Follow-up, and Safety Observation
timeFrame: Baseline up to 4.5 years
Other outcomes:
Locations:
city: Algiers
country: Algeria
facility: Centre hospitalo-univerisitaire de Rouiba;Service d'oncologie médicale
city: Algiers
country: Algeria
facility: Centre Anti Cancer Beau-fraisier;Service d'oncologie médicale
city: Annaba
country: Algeria
facility: CHU Annaba; Service d'Oncologie Médicale
city: Oran
country: Algeria
facility: EHS Oncologie Emir Abdelkader Oran; Service d'Oncologie Médicale
city: Casablanca
country: Morocco
facility: Clinique Littoral
city: Marrakech
country: Morocco
facility: Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
city: Rabat
country: Morocco
facility: Institut National D'oncologie Sidi Med Benabdellah
city: Jeddah
country: Saudi Arabia
facility: International Medical Center (IMC)
city: Riyadh
country: Saudi Arabia
facility: King Khaled Uni Hospital; Oncology
city: Ariana
country: Tunisia
facility: Abderrahmen Mami Hospital; Medical Oncology department
city: Sfax
country: Tunisia
facility: Habib Bourguiba Hospital; Oncology department
city: Sousse
country: Tunisia
facility: Farhat Hached Hospital; Oncology department
city: Tunis
country: Tunisia
facility: Institut Salah Azaïz; Service de Médecine Carcinologique
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty; Department of İnternal Medicine
city: Antalya
country: Turkey
facility: Akdeniz Univesity Medical Faculty
city: Diyarbakir
country: Turkey
facility: Dicle University Faculty of Medicine
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Gaziantep
country: Turkey
facility: Gaziantep Univ. Med. Fac.
city: İstanbul
country: Turkey
facility: İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Univ Medical
city: Istanbul
country: Turkey
facility: Marmara Uni Faculty of Medicine; Medical Oncology
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Sıhhiye, Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: