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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 (ESCAPE)

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ClinicalTrials.gov Identifier: NCT02194166
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE July 8, 2014
First Posted Date  ICMJE July 18, 2014
Last Update Posted Date June 10, 2019
Actual Study Start Date  ICMJE July 18, 2014
Actual Primary Completion Date July 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2017)
  • Participant Pain as Measured on a 10 Centimeter (cm) Visual Analogue Scale [ Time Frame: Week 13 up to Week 52 ]
  • Participant Discomfort as Measured on a 10 cm Visual Analogue Scale [ Time Frame: Week 13 up to Week 52 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2014)
  • Patient pain, as measured on a 10 cm Visual Analogue Scale [ Time Frame: Every treatment cycle, assessed up to 4 years ]
  • Patient discomfort, as measured on a 10 cm Visual Analogue Scale [ Time Frame: Every treatment cycle, assessed up to 4 years ]
Change History Complete list of historical versions of study NCT02194166 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2017)
  • Healthcare Professional Satisfaction With SC Formulation as Assessed by Health Care Professional Questionnaire (HCPQ) [ Time Frame: Week 22 ]
  • Patient Satisfaction With SC Formulation as Assessed by Patients Satisfaction Questionnaire (PSQ) [ Time Frame: Week 52 ]
  • Healthcare Professional Perceived Time Savings With SC Trastuzumab as Assessed by HCPQ [ Time Frame: Week 22 ]
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 3 years ]
  • Overall Survival [ Time Frame: From first study treatment to death from any cause, assessed up to approximately 4.5 years ]
  • 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 ]
  • Number of Days on Trastuzumab Treatment [ Time Frame: Week 1 up to Week 52 ]
  • Total Daily Dose of Trastuzumab [ Time Frame: Week 1 up to Week 52 ]
  • Cumulative Dose of Trastuzumab [ Time Frame: Week 1 up to Week 52 ]
  • Duration of Treatment [ Time Frame: Week 1 up to Week 52 ]
  • Duration of Safety Observation [ Time Frame: 28 days after last study treatment (up to Week 56) ]
  • Duration of Follow-Up [ Time Frame: 25 months after last study treatment (up to 3 years) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2014)
  • Healthcare professional satisfaction with SC formulation, assessed by Health Care Professional Questionnaire (HCPQ) [ Time Frame: Week 22 ]
  • Patient satisfaction with SC formulation, assessed by Patients Satisfaction Questionnaire (PSQ) [ Time Frame: Week 52 (Cycle 18) ]
  • Healthcare professional perceived time savings with SC trastuzumab, assessed by HCPQ [ Time Frame: Week 22 ]
  • Incidence of adverse events [ Time Frame: Up to 4 years ]
  • Overall Survival [ Time Frame: From first study treatment to death from any cause, assessed up to 4 years ]
  • Disease-free survival [ Time Frame: From first study treatment to documented disease progression or death, assessed up to 4 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Trastuzumab
    Trastuzumab IV or SC will be administered as described.
    Other Name: Herceptin
  • Drug: Paclitaxel
    Paclitaxel will be administered in accordance with local hospital practice.
  • Drug: Docetaxel
    Docetaxel will be administered in accordance with local hospital practice.
Study Arms  ICMJE
  • Experimental: Pre-Randomization (Trastuzumab IV)
    Trastuzumab IV will be given during the first 4 cycles for all participants before randomization for SC administration. A dose of 6 milligrams per kilogram (mg/kg) will be given every 3 weeks. All the participants will require a loading dose on Day 1 of Cycle 1, so they will receive 8 mg/kg followed by 6 mg/kg, 3 weeks later and then 3-weekly. Concurrent administration during the first 4 cycles of trastuzumab IV with paclitaxel/docetaxel will have to be performed in accordance with local hospital practice.
    Interventions:
    • Drug: Trastuzumab
    • Drug: Paclitaxel
    • Drug: Docetaxel
  • Experimental: Group A: Trastuzumab SC (First Vial Formulation, then SID)
    Participants will receive 7 cycles of SC trastuzumab 600 mg with assisted administration using a conventional syringe and needle (SC vial formulation) followed by 7 cycles of SC trastuzumab 600 mg SID administration after cross-over.
    Intervention: Drug: Trastuzumab
  • Experimental: Group B: Trastuzumab SC (First SID, then Vial Formulation)
    Participants will start with 7 cycles of SC trastuzumab 600 mg administration via SID and after cross-over will receive 7 injections of trastuzumab 600 mg with assisted administration using a conventional syringe and needle (SC vial formulation).
    Intervention: Drug: Trastuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2014)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 12, 2018
Actual Primary Completion Date July 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus,   Kazakhstan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02194166
Other Study ID Numbers  ICMJE ML28839
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP