Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer

NCT ID: NCT02402712

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 418 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-06
• Study Completion Date: 2019-02-22

Brief Summary

This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to receive study medication until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end, whichever occurs first. The anticipated time on study treatment is approximately 24 months. The target sample size is 400.

Conditions

Breast Cancer

Study Design

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

Study Groups

Herceptin SC + Perjeta IV + docetaxel IV

Single arm

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Intravenous administration according to local label/clinical practice, after Herceptin and Perjeta.

pertuzumab [Perjeta]

Intervention Type: DRUG

Intravenous infusion every 3 weeks. First dose: 840 mg. Subsequent doses: 420 mg

trastuzumab [Herceptin]

Intervention Type: DRUG

Subcutaneous administration of 600 mg/5 mL every 3 weeks

Interventions

Docetaxel

Intravenous administration according to local label/clinical practice, after Herceptin and Perjeta.

Intervention Type: DRUG

pertuzumab [Perjeta]

Intravenous infusion every 3 weeks. First dose: 840 mg. Subsequent doses: 420 mg

Intervention Type: DRUG

trastuzumab [Herceptin]

Subcutaneous administration of 600 mg/5 mL every 3 weeks

Intervention Type: DRUG

Other Intervention Names

RO4368451; RO0452317

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection. Patients with measurable and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 are eligible.
• HER2-positive disease (defined as either immunohistochemistry [IHC] 3 + or in situ hybridization [ISH] positive) as assessed by local laboratory on primary tumor or metastatic site if primary tumor not available
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• Left ventricular ejection fraction (LVEF) of at least 50%
• Negative serum pregnancy test result at baseline and use of effective contraception as defined by the protocol

Exclusion Criteria

• Previous systemic non-hormonal anti-cancer therapy for the metastatic or locally recurrent disease. Note: Prior to study entry, up to two lines of hormonal therapy for metastatic or locally recurrent disease are permitted, one of which may be in combination with everolimus.
• Disease-free interval of less than 6 months from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of breast cancer
• Previous approved or investigative anti-HER2 agents as neoadjuvant or adjuvant therapy for any breast cancer treatment, except Herceptin
• History of persistent Grade 2 or higher hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
• Radiographic evidence of central nervous system (CNS) metastases as assessed by computed tomography (CT) or magnetic resonance imaging (MRI), unless they have been treated and have been stable for at least 3 months and do not require ongoing corticosteroid treatment
• Current peripheral neuropathy of Grade 3 or greater
• History of other malignancy within the last 5 years prior to first dose of study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma
• Inadequate organ function
• Uncontrolled hypertension with or without medication
• Clinically significant cardiovascular disease
• History of LVEF decline to below 50% during or after prior Herceptin neo-adjuvant or adjuvant therapy
• Current known infection with HIV, hepatitis B virus, or hepatitis C virus
• Severe uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or that would put the patient at high risk for treatment-related complications, including severe pulmonary conditions/illness
• Pregnant or lactating women
• Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy
• History of receiving any investigational treatment within 28 days prior to first dose of study drug administration (dosing) or concurrent participation in any interventional clinical trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• 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

AZ Sint Jan

Bruges, , Belgium

UZ Brussel

Brussels, , Belgium

Cliniques Universitaires St-Luc

Brussels, , Belgium

CHU Sart-Tilman

Liège, , Belgium

Clinique Saint-Joseph

Liège, , Belgium

Sint Augustinus Wilrijk

Wilrijk, , Belgium

Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC

Gabrovo, , Bulgaria

Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

Plovdiv, , Bulgaria

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

Plovdiv, , Bulgaria

Comprehensive Cancer Center-Plovdiv

Plovdiv, , Bulgaria

Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District EOOD

Sofia, , Bulgaria

Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd

Varna, , Bulgaria

MDOZS Vrasta Ltd.

Vratsa, , Bulgaria

Moncton Hospital

Moncton, New Brunswick, Canada

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy

Ars-Laquenexy, , France

Medipole De Savoie; Departement Oncologie

Challes-les-Eaux, , France

Hopital Prive Sainte Marie

Chalon-sur-Saône, , France

Centre Hospitalier Louis Pasteur

Chartes Le Coudray, , France

Pole Sante Republique; Pharmacie Oncologique

Clermont-Ferrand, , France

Centre Georges Francois Leclerc

Dijon, , France

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, , France

CHU de Grenoble

Grenoble, , France

Hopital Europeen

Marseille, , France

Centre Hospitalier de Mont de Marsan - Hopital Layne

Mont-de-Marsan, , France

Hopital Saint Joseph; Service de Rhumatologie

Paris, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Strasbourg Oncologie Libérale

Strasbourg, , France

Gustave Roussy

Villejuif, , France

Studienzentrum Aschaffenburg

Aschaffenburg, , Germany

Onkologische Schwerpunktpraxis Dr. Joerg Schilling

Berlin, , Germany

Universitaetsklinikum Erlangen

Erlangen, , Germany

Kliniken Essen-Mitte

Essen, , Germany

Universitätsklinikum Essen

Essen, , Germany

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

Freiburg im Breisgau, , Germany

Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

Lübeck, , Germany

Onkologische Schwerpunktpraxis Lübeck

Lübeck, , Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, , Germany

Suedharz Klinikum Nordhausen gGmbH

Nordhausen, , Germany

Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

Offenbach, , Germany

Johanniter-Krankenhaus Genthin - Stendal GmbH; Gynäkologie und gynäkologische Onkologie

Stendal, , Germany

Klinikum Mutterhaus der Borromaeerinnen

Trier, , Germany

Universitätsklinikum Würzburg

Würzburg, , Germany

Szent Margit Hospital; Dept. of Oncology

Budapest, , Hungary

Ogyi, Orszagos Gyogyszereszeti Intezet

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Szent Imre Egyetemi Oktatokorhaz

Budapest, , Hungary

Orszagos Onkologiai Intezet

Budapest, , Hungary

Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

Budapest, , Hungary

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

Miskolc, , Hungary

Azienda Ospedaliera Regionale San Carlo

Potenza, Basilicate, Italy

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

Meldola, Emilia-Romagna, Italy

Azienda Ospedaliero - Universitaria di Modena Policlinico

Modena, Emilia-Romagna, Italy

Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova

Reggio Emilia, Emilia-Romagna, Italy

Ospedale Infermi di Rimini

Rimini, Emilia-Romagna, Italy

Istituti Fisioterapici Ospitalieri

Rome, Lazio, Italy

Ospedale Policlinico San Martino

Genoa, Liguria, Italy

Asst Papa Giovanni XXIII

Bergamo, Lombardy, Italy

Istituto Europeo Di Oncologia

Milan, Lombardy, Italy

Istituto Clinico Humanitas

Rozzano (MI), Lombardy, Italy

Asst Della Valtellina E Dell'Alto Lario

Sondrio, Lombardy, Italy

Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

Catania, Sicily, Italy

Ospedale Santa Maria Annunziata

Bagno a Ripoli, Tuscany, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, Italy

Azienda USL 5 di Pisa

Pisa, Tuscany, Italy

Ospedale Santo Stefano, Azienda USL Centro Prato

Prato, Tuscany, Italy

Azienda Ospedaliera Santa Maria di Terni

Terni, Umbria, Italy

Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna

Cona (Ferrara), Veneto, Italy

Ospedale Sacro Cuore Don Calabria

Negrar, Veneto, Italy

IOV - Istituto Oncologico Veneto IRCCS

Padua, Veneto, Italy

"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"

Verona, Veneto, Italy

Consultorio de Medicina Especializada

México, Mexico CITY (federal District), Mexico

Grupo Medico Camino

DF, , Mexico

Superare Centro de Infusion S.A. de C.V.

México, , Mexico

Fundacion de Cancer de Mama.A.C.

México, , Mexico

Centro Medico San Jose

Monterrey, Nuevo Leon, , Mexico

Cancerología

Querétaro, , Mexico

Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie

Bialystok, , Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii

Gdansk, , Poland

Szpitale Pomorskie Sp. z o. o.

Gdynia, , Poland

Przychodnia Lekarska KOMED

Konin, , Poland

Szpital Uniwersytecki w Krakowie

Krakow, , Poland

Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

Lublin, , Poland

Samodzielny Publiczny Zakład Opieki Zdrowotnej MSW z W-MCO w Olsztynie

Olsztyn, , Poland

Samodzielny Publiczny Zakład Opieki Zdrowotnej Opolskie Centrum Onkologii

Opole, , Poland

Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna

Poznan, , Poland

Wielkopolskie Centrum Onkologii

Poznan, , Poland

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna

Warsaw, , Poland

MAGODENT Sp. z o.o.

Warsaw, , Poland

Hospital de Braga

Braga, , Portugal

Instituto Portugues Oncologia de Coimbra Francisco Gentil, EPE

Coimbra, , Portugal

Hospital da Luz

Lisbon, , Portugal

Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria

Lisbon, , Portugal

IPO do Porto; Servico de Oncologia Medica

Porto, , Portugal

Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario

Santiago de Compostela, LA Coruña, Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Madrid, , Spain

Fundacion Instituto Valenciano de Oncologia (IVO)

Valencia, , Spain

Betsi Cadwaladr University Health Board

Bangor Gwynedd, , United Kingdom

Velindre Cancer Centre

Cardiff, , United Kingdom

Dorset County Hospital

Dorchester, , United Kingdom

University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

Leicester, , United Kingdom

Guys and St Thomas NHS Foundation Trust, Guys Hospital

London, , United Kingdom

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Mount Vernon Cancer Centre

Northwood, , United Kingdom

Peterborough City Hospital

Peterborough, , United Kingdom

Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital

Portsmouth, , United Kingdom

Royal Cornwall Hospitals NHS Trust

Truro, , United Kingdom

Countries

Belgium; Bulgaria; Canada; France; Germany; Hungary; Italy; Mexico; Poland; Portugal; Spain; United Kingdom

References

Kuemmel S, Tondini CA, Abraham J, Nowecki Z, Itrych B, Hitre E, Karaszewska B, Juarez-Ramiro A, Morales-Vasquez F, Perez-Garcia JM, Cardona-Huerta S, Monturus E, Sequi M, Restuccia E, Benyunes M, Martin M. Subcutaneous trastuzumab with pertuzumab and docetaxel in HER2-positive metastatic breast cancer: Final analysis of MetaPHER, a phase IIIb single-arm safety study. Breast Cancer Res Treat. 2021 Jun;187(2):467-476. doi: 10.1007/s10549-021-06145-3. Epub 2021 Mar 21.

Reference Type: DERIVED

PMID: 33748921 (View on PubMed)

Other Identifiers

2014-001458-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BO29159

Identifier Type: -

Identifier Source: org_study_id