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)

NCT ID: NCT01926886

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-19
• Study Completion Date: 2017-07-19

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trastuzumab

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).

Group Type: EXPERIMENTAL

Trastuzumab

Intervention Type: 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.

Health Care Professionals

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Trastuzumab

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.

Intervention Type: DRUG

Other Intervention Names

Herceptin

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Onze Lieve Vrouwziekenhuis Aalst

Aalst, , Belgium

Imeldaziekenhuis

Bonheiden, , Belgium

AZ Sint Jan

Bruges, , Belgium

CHU St Pierre (St Pierre)

Brussels, , Belgium

AZ Maria Middelares

Ghent, , Belgium

AZ Sint Lucas (Sint Lucas)

Ghent, , Belgium

UZ Gent

Ghent, , Belgium

CH Jolimont - Lobbes (Jolimont)

Haine-Saint-Paul, , Belgium

Clinique Saint-Joseph

Liège, , Belgium

CHU Ambroise Paré

Mons, , Belgium

CHR de Namur

Namur, , Belgium

AZ Damiaan

Ostend, , Belgium

AZ Turnhout Sint Elisabeth

Turnhout, , Belgium

Soroka Medical Center; Oncology Dept

Beersheba, , Israel

Rambam Medical Center; Oncology

Haifa, , Israel

Hadassah Ein Karem Hospital; Oncology Dept

Jerusalem, , Israel

Meir Medical Center; Oncology

Kfar Saba, , Israel

Western Galilee Hospital; Oncology-Nahariya

Nahariya, , Israel

Rabin MC; Davidof Center - Oncology Institute

Petah Tikva, , Israel

Chaim Sheba medical center, Oncology division

Ramat Gan, , Israel

Kaplan Medical Center; Oncology Inst.

Rehovot, , Israel

Sourasky / Ichilov Hospital; Dept. of Oncology

Tel Aviv, , Israel

Assaf Harofeh; Oncology

Ẕerifin, , Israel

Countries

Belgium; Israel

References

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.

Reference Type: DERIVED

PMID: 32240454 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2013-000123-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML28794

Identifier Type: -

Identifier Source: org_study_id