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Completed

NCT Number: NCT02194166

A Study to Investigate the Tolerability of Subcutaneous (SC) Trastuzumab Administration in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early Breast Cancer (eBC) Using Either a Single-Use Injection Device or Manual Administration

This multicenter study in participants with HER2-positive eBC will investigate participants' pain and discomfort of SC trastuzumab (Herceptin) administered either via a single-use injection device (SID) or via vial for manual administration using a hand-held syringe (SC vial). In total, participants will obtain at least 18 cycles/1 year of trastuzumab (4 cycles of intravenous [IV] and 14 cycles of SC trastuzumab).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

State Inst N.N. Alexandrov Republican Scientific & Practical Centre of Oncology & Medical Radiology, A/g Lesnoy, Minsk Region, Belarus

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Hormonal therapy allowed as per institutional guidelines
  • Left ventricular ejection fraction (LVEF) of greater than or equal to (>/=) 55 percent (%) measured by echocardiography (ECHO) prior to first dose of trastuzumab
  • HER2-positive disease immunohistochemistry (IHC) 3+ 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)
  • Participants who have completed all (neo)adjuvant treatment or participants after adjuvant chemotherapy with doxorubicin and cyclophosphamide (AC) to whom the 4 subsequent cycles of trastuzumab in combination with paclitaxel or docetaxel are indicated per local practice
  • Not more than 3 months should have elapsed since the last dose of adjuvant chemotherapy in case of subsequent treatment scheme

Exclusion criteria

  • Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
  • History of other malignancy that can 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. Participants with previous ductal carcinoma in situ (DCIS) of the breast are also eligible for the study
  • Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
  • Participants with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
  • Prior maximum cumulative dose of doxorubicin >360 mg/m2 or maximum cumulative dose of epirubicin >720 mg/m2 or equivalent
  • 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 anticancer 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 the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g., difficult to control asthma
  • Inadequate bone marrow, hepatic, or renal function
  • Major surgical procedure or significant traumatic injury within 14 days prior to the first dose of study treatment or anticipated need for major surgery during the course of study treatment

Treatment and study plan

Trastuzumab

Drug

Trastuzumab IV or SC will be administered as described.

Other names: Herceptin

paclitaxel

Drug

Paclitaxel will be administered in accordance with local hospital practice.

docetaxel

Drug

Docetaxel will be administered in accordance with local hospital practice.

Primary outcomes

  1. Participant Pain as Measured on a 10 Centimeter (cm) Visual Analogue Scale

    Time frame: Week 13 up to Week 52

  2. Participant Discomfort as Measured on a 10 cm Visual Analogue Scale

    Time frame: Week 13 up to Week 52

Secondary outcomes

  1. Healthcare Professional Satisfaction With SC Formulation as Assessed by Health Care Professional Questionnaire (HCPQ)

    Time frame: Week 22

  2. Patient Satisfaction With SC Formulation as Assessed by Patients Satisfaction Questionnaire (PSQ)

    Time frame: Week 52

  3. Healthcare Professional Perceived Time Savings With SC Trastuzumab as Assessed by HCPQ

    Time frame: Week 22

  4. Percentage of Participants With Adverse Events

    Time frame: Baseline up to approximately 3 years

  5. Overall Survival

    Time frame: From first study treatment to death from any cause, assessed up to approximately 4.5 years

  6. Disease-Free Survival, Assessed as per Institutional Practice or American Society of Clinical Oncology (ASCO) Adjuvant Follow-up Guidelines 2006

    Time frame: From first study treatment to documented disease progression or death, assessed up to approximately 3 years

  7. Number of Days on Trastuzumab Treatment

    Time frame: Week 1 up to Week 52

  8. Total Daily Dose of Trastuzumab

    Time frame: Week 1 up to Week 52

  9. Cumulative Dose of Trastuzumab

    Time frame: Week 1 up to Week 52

  10. Duration of Treatment

    Time frame: Week 1 up to Week 52

  11. Duration of Safety Observation

    Time frame: 28 days after last study treatment (up to Week 56)

  12. Duration of Follow-Up

    Time frame: 25 months after last study treatment (up to 3 years)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-Label, Randomized, Cross-Over, Multicenter, Phase IIIb Study, to Assess Patients' Tolerability of Trastuzumab Administrated Subcutaneously (SC) Either Via a Single Use Injection Device (SID) or Via Vial for Manual Administration (SC Vial) in Patients With HER2-Positive Early Breast Cancer (eBC)

Acronym: ESCAPE

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 18, 2014
Registry last updated
Jun 10, 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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