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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Trastuzumab

• Registration Number: NCT02040935
• Lead Sponsor: Hoffmann-La Roche

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Study Start: 2014-02-21
• Primary Completion: 2018-09-14
• Study Completion: 2018-09-14
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trastuzumab	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).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)	From Baseline up to approximately 4 years

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Trough Concentrations (Ctrough) of Trastuzumab	Pre-dose (within 1 day before trastuzumab administration) at Cycles 2, 3, 9, and 10, 12 or 13 (cycle length=21 days)
Health Survey Short Form-36 (SF-36) Score	Cycles 3 and 9 (cycle length=21 days)
Mood and Anxiety Questionnaire (MASQ) Score	Cycles 3 and 9 (cycle length=21 days)
Percentage of Participants Choosing to Return to Hospital Administration	Cycle 6 (cycle length=21 days)

Trial Locations

Locations (17)

Haga Ziekenhuis; 🇳🇱 Den Haag, Netherlands

Tergooiziekenhuizen, loc. Hilversum; 🇳🇱 Hilversum, Netherlands

Zuyderland ziekenhuis locatie Geleen; 🇳🇱 Sittard-Geleen, Netherlands

Martini Ziekenhuis; 🇳🇱 Groningen, Netherlands

Meander Medisch Centrum; Locatie Lichtenberg; 🇳🇱 Amersfoort, Netherlands

Medisch Centrum Alkmaar; 🇳🇱 Alkmaar, Netherlands

IJsselland Ziekenhuis; 🇳🇱 Capelle Aan De Yssel, Netherlands

Amphia ziekenhuis, locatie langendijk; 🇳🇱 Breda, Netherlands

Reinier de Graaf Gasthuis; Oncology; 🇳🇱 Delft, Netherlands

Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde; 🇳🇱 EDE, Netherlands

Kennemer Gasthuis; 🇳🇱 Haarlem, Netherlands

Ziekenhuisgroep Twente, Hengelo; 🇳🇱 Hengelo, Netherlands

Franciscus Ziekenhuis; 🇳🇱 Roosendaal, Netherlands

Spaarne Ziekenhuis Haarlem; Oncologie; 🇳🇱 Hoofddorp, Netherlands

St. Antonius Ziekenhuis Nieuwegein; 🇳🇱 Nieuwegein, Netherlands

VieCuri - Medisch Centrum voor Noord-Limburg; 🇳🇱 Venlo, Netherlands

Isala Klinieken; 🇳🇱 Zwolle, Netherlands