A Study of SC Administration of Trastuzumab (Herceptin) by SID at Home in HER2-Positive EBC Participants

NCT ID: NCT02040935

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-21
• Study Completion Date: 2018-09-14

Brief Summary

This single-arm, open-label, local multicenter study will evaluate the safety and tolerability of trastuzumab administered subcutaneously (SC) by a single-use injection device (SID) in participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), following surgery and chemotherapy (neo-adjuvant or adjuvant).

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trastuzumab

Participants will receive 600 milligrams (mg) trastuzumab SC by SID every 3 weeks (Q3W) for up to a total of 1 year, unless disease recurrence, unacceptable toxicity or participant withdrawal occurs. The first 3 administrations will be done at hospital, after that participants will be permitted to self-administer under the supervision of a healthcare professional (HCP).

Group Type: EXPERIMENTAL

Trastuzumab

Intervention Type: DRUG

600 mg SC Q3W by SID

Interventions

Trastuzumab

600 mg SC Q3W by SID

Intervention Type: DRUG

Other Intervention Names

Herceptin

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
• HER2-positive disease
• 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
• Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 50 percent (%)
• 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 radiotherapy will be permitted
• Completion of surgery and chemotherapy (if applicable)

Exclusion Criteria

• History of other malignancy, except for 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 the last 5 years
• Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
• Participants with other concurrent serious diseases that might 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, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), poorly controlled hypertension
• Pregnant or lactating women
• Women of childbearing potential and male participants with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods during study treatment
• Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
• Known hypersensitivity to trastuzumab, murine proteins, to any excipients of Herceptin, including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma
• Inadequate hepatic or renal function

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Medisch Centrum Alkmaar

Alkmaar, , Netherlands

Meander Medisch Centrum; Locatie Lichtenberg

Amersfoort, , Netherlands

Amphia ziekenhuis, locatie langendijk

Breda, , Netherlands

IJsselland Ziekenhuis

Capelle aan den IJssel, , Netherlands

Reinier de Graaf Gasthuis; Oncology

Delft, , Netherlands

Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde

Ede, , Netherlands

Martini Ziekenhuis

Groningen, , Netherlands

Kennemer Gasthuis

Haarlem, , Netherlands

Ziekenhuisgroep Twente, Hengelo

Hengelo, , Netherlands

Tergooiziekenhuizen, loc. Hilversum

Hilversum, , Netherlands

Spaarne Ziekenhuis Haarlem; Oncologie

Hoofddorp, , Netherlands

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, , Netherlands

Franciscus Ziekenhuis

Roosendaal, , Netherlands

Zuyderland ziekenhuis locatie Geleen

Sittard-Geleen, , Netherlands

Haga Ziekenhuis

The Hague, , Netherlands

VieCuri - Medisch Centrum voor Noord-Limburg

Venlo, , Netherlands

Isala Klinieken

Zwolle, , Netherlands

Countries

Netherlands

Other Identifiers

2013-000829-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML28878

Identifier Type: -

Identifier Source: org_study_id