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Completed

NCT Number: NCT02040935

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medisch Centrum Alkmaar, Alkmaar, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trastuzumab

Drug

600 mg SC Q3W by SID

Other names: Herceptin

Primary outcomes

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

    Time frame: From Baseline up to approximately 4 years

Secondary outcomes

  1. Pharmacokinetics: Trough Concentrations (Ctrough) of Trastuzumab

    Time frame: Pre-dose (within 1 day before trastuzumab administration) at Cycles 2, 3, 9, and 10, 12 or 13 (cycle length=21 days)

  2. Health Survey Short Form-36 (SF-36) Score

    Time frame: Cycles 3 and 9 (cycle length=21 days)

  3. Mood and Anxiety Questionnaire (MASQ) Score

    Time frame: Cycles 3 and 9 (cycle length=21 days)

  4. Percentage of Participants Choosing to Return to Hospital Administration

    Time frame: Cycle 6 (cycle length=21 days)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

HOMERUS: A Local, Open Label, Multicentre, Phase IIIB Study, Investigating Subcutaneous Trastuzumab Administered at Home With Single Injection Device in Patients With HER2-Positive Early Breast Cancer

Acronym: HOMERUS

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 20, 2014
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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