A Study of Subcutaneous At Home Administration of Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2-positive (HER2+) Early Breast Cancer (eBC)

NCT01926886 | Completed Phase 3 Results

• 2 other identifiers: ML287942013-000123-13
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 23

Brief Summary

This single arm, multicenter study will evaluate the safety of assisted subcutaneous administration of trastuzumab in participants with HER2+ eBC. Participants who have completed the first 6 cycles of intravenous (IV) trastuzumab as part of the (neo)adjuvant treatment will be eligible to receive a further 12 cycles of trastuzumab in this study. Participants will receive IV trastuzumab at initial loading dose of 8 milligrams per kilogram (mg/kg) body weight (BW) for three-weekly (q3w) regimen and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (cycles 7-9) in hospital followed by subcutaneous (SC) administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

  An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non- serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An emergent AE was defined as occurring within 35 days after last treatment administration.

  Up to 45 months

Secondary Outcomes (8)

• Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital

  Prior (0 hour) to first trastuzumab SC administration at Cycle 13 (cycle length =21 days)

• Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home

  Prior (0 hour) to fifth trastuzumab SC administration at Cycle 17 (cycle length=21 days)

• Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire

  Prior (0 hours) to Cycles 7, 10, 13, 16 (Each cycle=21 days)

• Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire

  Prior (0 hours) to Cycles 7, 10, 13, 16 (Each cycle=21 days)

• Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital

  Prior (0 hours) to Cycle 12 (cycle length=21 days)

Study Arms (2)

Trastuzumab

EXPERIMENTAL

Participants with HER2+ eBC who completed the first 6 cycles of trastuzumab IV infusion as part of the (neo) adjuvant treatment will be included to continue to receive 12 cycles of trastuzumab to complete a total of 18 cycles of trastuzumab. Participants will receive trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).

Drug: Trastuzumab

Health Care Professionals

NO INTERVENTION

Health Care Professionals (HCPs) included for polling purposes. HCPs were not enrolled in the study.

Interventions

Trastuzumab DRUG

Trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w; Trastuzumab 600 mg q3w SC injection will be administered as per the schedule specified in the arm.

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 immunohistochemistry (IHC)3+ or in situ hybridization (ISH) positive, in line with local reimbursement criteria and determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Hormonal therapy will be allowed as per institutional guidelines
• Left ventricular ejection fraction (LVEF) of greater than or equal to (\>/=) 50% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab SC, or, for those who were receiving trastuzumab when beginning the study, documented results within an acceptable limit from a cardiac assessment within 3 months prior to enrollment
• Participants have completed the first 6 cycles of trastuzumab IV as part of the (neo)adjuvant treatment
• No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, (neo-adjuvant or adjuvant)
• Use of concurrent curative radiotherapy will be permitted

You may not qualify if:

• History of other malignancy which could affect compliance with the protocol or interpretation of results. Participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and patients with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible
• 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
• 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
• Women of childbearing potential and male participants with partners of childbearing potential who are unable or unwilling to use adequate contraceptive measures during study treatment
• Concurrent enrollment in another clinical trial using an investigational anti-cancer 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 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 bone marrow, hepatic or renal function

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (23)

Onze Lieve Vrouwziekenhuis Aalst

Aalst, 9300, Belgium

Location

Imeldaziekenhuis

Bonheiden, 2820, Belgium

Location

AZ Sint Jan

Bruges, 8000, Belgium

Location

CHU St Pierre (St Pierre)

Brussels, 1000, Belgium

Location

AZ Maria Middelares

Ghent, 9000, Belgium

Location

AZ Sint Lucas (Sint Lucas)

Ghent, 9000, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

CH Jolimont - Lobbes (Jolimont)

Haine-Saint-Paul, 7100, Belgium

Location

Clinique Saint-Joseph

Liège, 4000, Belgium

Location

CHU Ambroise Paré

Mons, 7000, Belgium

Location

CHR de Namur

Namur, 5000, Belgium

Location

AZ Damiaan

Ostend, 8400, Belgium

Location

AZ Turnhout Sint Elisabeth

Turnhout, 2300, Belgium

Location

Soroka Medical Center; Oncology Dept

Beersheba, 8410100, Israel

Location

Rambam Medical Center; Oncology

Haifa, 3109601, Israel

Location

Hadassah Ein Karem Hospital; Oncology Dept

Jerusalem, 9112000, Israel

Location

Meir Medical Center; Oncology

Kfar Saba, 4428164, Israel

Location

Western Galilee Hospital; Oncology-Nahariya

Nahariya, 2210001, Israel

Location

Rabin MC; Davidof Center - Oncology Institute

Petah Tikva, 4941492, Israel

Location

Chaim Sheba medical center, Oncology division

Ramat Gan, 5262000, Israel

Location

Kaplan Medical Center; Oncology Inst.

Rehovot, 7610001, Israel

Location

Sourasky / Ichilov Hospital; Dept. of Oncology

Tel Aviv, 6423906, Israel

Location

Assaf Harofeh; Oncology

Ẕerifin, 6093000, Israel

Location

Related Publications (1)

• Denys H, Martinez-Mena CL, Martens MT, D'Hondt RG, Graas ML, Evron E, Fried G, Ben-Baruch NE, Vulsteke C, Van Steenberghe MM. Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer. Breast Cancer Res Treat. 2020 May;181(1):97-105. doi: 10.1007/s10549-020-05604-7. Epub 2020 Apr 2.

  PMID: 32240454 DERIVED

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

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: August 19, 2013
• First Posted: August 21, 2013
• Study Start: November 19, 2013
• Primary Completion: September 4, 2015
• Study Completion: July 19, 2017
• Last Updated: September 18, 2019
• Results First Posted: September 18, 2019

Record last verified: 2019-08

Locations

IL (10); BE (13)