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

NCT02040935 | Completed Phase 3

• 2 other identifiers: ML288782013-000829-31
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 17

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

  From Baseline up to approximately 4 years

Secondary Outcomes (4)

• 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)

Study Arms (1)

Trastuzumab

EXPERIMENTAL

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).

Drug: Trastuzumab

Interventions

Trastuzumab DRUG

600 mg SC Q3W by SID

Also known as: Herceptin

Trastuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (17)

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Location

Meander Medisch Centrum; Locatie Lichtenberg

Amersfoort, 3818 ES, Netherlands

Location

Amphia ziekenhuis, locatie langendijk

Breda, 4819 EV, Netherlands

Location

IJsselland Ziekenhuis

Capelle aan den IJssel, 2906 ZC, Netherlands

Location

Reinier de Graaf Gasthuis; Oncology

Delft, 2600 GA, Netherlands

Location

Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde

Ede, 6716 RP, Netherlands

Location

Martini Ziekenhuis

Groningen, 9728 MG, Netherlands

Location

Kennemer Gasthuis

Haarlem, 2035 RC, Netherlands

Location

Ziekenhuisgroep Twente, Hengelo

Hengelo, 7555 DL, Netherlands

Location

Tergooiziekenhuizen, loc. Hilversum

Hilversum, 1213 HX, Netherlands

Location

Spaarne Ziekenhuis Haarlem; Oncologie

Hoofddorp, 2134 TM, Netherlands

Location

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, 3430 EM, Netherlands

Location

Franciscus Ziekenhuis

Roosendaal, 4708 AE, Netherlands

Location

Zuyderland ziekenhuis locatie Geleen

Sittard-Geleen, 6162 BG, Netherlands

Location

Haga Ziekenhuis

The Hague, 2504 LN, Netherlands

Location

VieCuri - Medisch Centrum voor Noord-Limburg

Venlo, 5912 BL, Netherlands

Location

Isala Klinieken

Zwolle, 8011 JW, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 20, 2014
• Study Start: February 21, 2014
• Primary Completion: September 14, 2018
• Study Completion: September 14, 2018
• Last Updated: August 22, 2019

Record last verified: 2019-08

Locations

NL (17)