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

Breast Cancer Clinical Trial

— ESCAPE  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194166
• Other study ID #: ML28839
• Status: Completed
• Phase: Phase 3
• Start date: July 18, 2014
• Est. completion date: July 12, 2018

Study information

• Verified date: June 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 12, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Trastuzumab
Trastuzumab IV or SC will be administered as described.
• Paclitaxel
Paclitaxel will be administered in accordance with local hospital practice.
• Docetaxel
Docetaxel will be administered in accordance with local hospital practice.

Locations

Country	Name	City	State
Belarus	State Inst N.N. Alexandrov Republican Scientific & Practical Centre of Oncology & Medical Radiology	A/g Lesnoy, Minsk Region
Belarus	Healthcare Institution "Brest Regional Oncologic Dispensary"	Brest
Belarus	Minsk City Clinical Oncologic Dispensary	Minsk
Belarus	Vitebsk Regional Clinical Oncology Dispensary	Vitebsk
Kazakhstan	Almaty Cancer Hospital; Chemotherapy department	Almaty
Kazakhstan	Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department	Almaty
Kazakhstan	Oncology centre of Astana; Chemotherapy department	Astana

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Belarus,  Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Pain as Measured on a 10 Centimeter (cm) Visual Analogue Scale		Week 13 up to Week 52
Primary	Participant Discomfort as Measured on a 10 cm Visual Analogue Scale		Week 13 up to Week 52
Secondary	Healthcare Professional Satisfaction With SC Formulation as Assessed by Health Care Professional Questionnaire (HCPQ)		Week 22
Secondary	Patient Satisfaction With SC Formulation as Assessed by Patients Satisfaction Questionnaire (PSQ)		Week 52
Secondary	Healthcare Professional Perceived Time Savings With SC Trastuzumab as Assessed by HCPQ		Week 22
Secondary	Percentage of Participants With Adverse Events		Baseline up to approximately 3 years
Secondary	Overall Survival		From first study treatment to death from any cause, assessed up to approximately 4.5 years
Secondary	Disease-Free Survival, Assessed as per Institutional Practice or American Society of Clinical Oncology (ASCO) Adjuvant Follow-up Guidelines 2006		From first study treatment to documented disease progression or death, assessed up to approximately 3 years
Secondary	Number of Days on Trastuzumab Treatment		Week 1 up to Week 52
Secondary	Total Daily Dose of Trastuzumab		Week 1 up to Week 52
Secondary	Cumulative Dose of Trastuzumab		Week 1 up to Week 52
Secondary	Duration of Treatment		Week 1 up to Week 52
Secondary	Duration of Safety Observation		28 days after last study treatment (up to Week 56)
Secondary	Duration of Follow-Up		25 months after last study treatment (up to 3 years)