Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer
2 other identifiers
interventional
418
12 countries
112
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started May 2015
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2015
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedStudy Start
First participant enrolled
May 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2019
CompletedSeptember 6, 2019
September 1, 2019
3.8 years
March 23, 2015
September 4, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence of adverse events (AEs)
Up to 24 months after the last patient has been enrolled, approximately 3.5 years
Incidence and severity of adverse events Grade >/= 3, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0
Up to 24 months after the last patient has been enrolled, approximately 3.5 years
Incidence of cardiac events (composite outcome measure): congestive heart failure (CHF) and cardiac death
Up to 24 months after the last patient has been enrolled, approximately 3.5 years
Secondary Outcomes (4)
Progression-free survival, tumor assessments according to RECIST v1.1
Up to 3.5 years
Overall survival
Up to 3.5 years
Objective response rate, defined as a complete response (CR) or a partial response (PR)
Up to 3.5 years
Incidence of anti-Herceptin, anti-rHuPH20 antibodies
Up to 3.5 years
Study Arms (1)
Herceptin SC + Perjeta IV + docetaxel IV
EXPERIMENTALSingle arm
Interventions
Intravenous administration according to local label/clinical practice, after Herceptin and Perjeta.
Intravenous infusion every 3 weeks. First dose: 840 mg. Subsequent doses: 420 mg
Subcutaneous administration of 600 mg/5 mL every 3 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (112)
AZ Sint Jan
Bruges, 8000, Belgium
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
Clinique Saint-Joseph
Liège, 4000, Belgium
Sint Augustinus Wilrijk
Wilrijk, 2610, Belgium
Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC
Gabrovo, 5300, Bulgaria
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
Plovdiv, 4000, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, 4002, Bulgaria
Comprehensive Cancer Center-Plovdiv
Plovdiv, 4004, Bulgaria
Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District EOOD
Sofia, 1233, Bulgaria
Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd
Varna, 9010, Bulgaria
MDOZS Vrasta Ltd.
Vratsa, 3000, Bulgaria
Moncton Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy
Ars-Laquenexy, 57530, France
Medipole De Savoie; Departement Oncologie
Challes-les-Eaux, 73190, France
Hopital Prive Sainte Marie
Chalon-sur-Saône, 71100, France
Centre Hospitalier Louis Pasteur
Chartes Le Coudray, 28630, France
Pole Sante Republique; Pharmacie Oncologique
Clermont-Ferrand, 63050, France
Centre Georges Francois Leclerc
Dijon, 21000, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, 38028, France
CHU de Grenoble
Grenoble, 38043, France
Hopital Europeen
Marseille, 13003, France
Centre Hospitalier de Mont de Marsan - Hopital Layne
Mont-de-Marsan, 40024, France
Hopital Saint Joseph; Service de Rhumatologie
Paris, 75674, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Strasbourg Oncologie Libérale
Strasbourg, 67000, France
Gustave Roussy
Villejuif, 94800, France
Studienzentrum Aschaffenburg
Aschaffenburg, 63739, Germany
Onkologische Schwerpunktpraxis Dr. Joerg Schilling
Berlin, 10317, Germany
Universitaetsklinikum Erlangen
Erlangen, 91054, Germany
Kliniken Essen-Mitte
Essen, 45136, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, 79110, Germany
Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I
Lübeck, 23538, Germany
Onkologische Schwerpunktpraxis Lübeck
Lübeck, 23562, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, 55101, Germany
Suedharz Klinikum Nordhausen gGmbH
Nordhausen, 99734, Germany
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
Offenbach, 63069, Germany
Johanniter-Krankenhaus Genthin - Stendal GmbH; Gynäkologie und gynäkologische Onkologie
Stendal, 39576, Germany
Klinikum Mutterhaus der Borromaeerinnen
Trier, 54290, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
Szent Margit Hospital; Dept. of Oncology
Budapest, 1032, Hungary
Ogyi, Orszagos Gyogyszereszeti Intezet
Budapest, 1051, Hungary
Semmelweis Egyetem
Budapest, 1083, Hungary
Szent Imre Egyetemi Oktatokorhaz
Budapest, 1115, Hungary
Orszagos Onkologiai Intezet
Budapest, 1122, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Budapest, H-1077, Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
Miskolc, 3526, Hungary
Azienda Ospedaliera Regionale San Carlo
Potenza, Basilicate, 85100, Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
Meldola, Emilia-Romagna, 47014, Italy
Azienda Ospedaliero - Universitaria di Modena Policlinico
Modena, Emilia-Romagna, 41110, Italy
Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, 42123, Italy
Ospedale Infermi di Rimini
Rimini, Emilia-Romagna, 47900, Italy
Istituti Fisioterapici Ospitalieri
Rome, Lazio, 00144, Italy
Ospedale Policlinico San Martino
Genoa, Liguria, 16132, Italy
Asst Papa Giovanni XXIII
Bergamo, Lombardy, 24100, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, 20141, Italy
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, 20089, Italy
Asst Della Valtellina E Dell'Alto Lario
Sondrio, Lombardy, 23100, Italy
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
Catania, Sicily, 95123, Italy
Ospedale Santa Maria Annunziata
Bagno a Ripoli, Tuscany, 50012, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50141, Italy
Azienda USL 5 di Pisa
Pisa, Tuscany, 56100, Italy
Ospedale Santo Stefano, Azienda USL Centro Prato
Prato, Tuscany, 59100, Italy
Azienda Ospedaliera Santa Maria di Terni
Terni, Umbria, 20089, Italy
Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna
Cona (Ferrara), Veneto, 44124, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, Veneto, 37024, Italy
IOV - Istituto Oncologico Veneto IRCCS
Padua, Veneto, 35128, Italy
"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"
Verona, Veneto, 37124, Italy
Consultorio de Medicina Especializada
México, Mexico CITY (federal District), 03100, Mexico
Grupo Medico Camino
DF, 03310, Mexico
Superare Centro de Infusion S.A. de C.V.
México, 06760, Mexico
Fundacion de Cancer de Mama.A.C.
México, Mexico
Centro Medico San Jose
Monterrey, Nuevo Leon, 64710, Mexico
Cancerología
Querétaro, 76090, Mexico
Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie
Bialystok, 15-027, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk, 80-219, Poland
Szpitale Pomorskie Sp. z o. o.
Gdynia, 81-519, Poland
Przychodnia Lekarska KOMED
Konin, 625000, Poland
Szpital Uniwersytecki w Krakowie
Krakow, 31-501, Poland
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Lublin, 20-090, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSW z W-MCO w Olsztynie
Olsztyn, 10-228, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej Opolskie Centrum Onkologii
Opole, 45-061, Poland
Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
Poznan, 60-569, Poland
Wielkopolskie Centrum Onkologii
Poznan, 61-866, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna
Warsaw, 00-973, Poland
MAGODENT Sp. z o.o.
Warsaw, 04-125, Poland
Hospital de Braga
Braga, 4710-243, Portugal
Instituto Portugues Oncologia de Coimbra Francisco Gentil, EPE
Coimbra, 3000-075, Portugal
Hospital da Luz
Lisbon, 1500-650, Portugal
Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
Lisbon, 1649-035, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, 4200-072, Portugal
Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario
Santiago de Compostela, LA Coruña, 15706, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28040, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid, 28222, Spain
Fundacion Instituto Valenciano de Oncologia (IVO)
Valencia, 46009, Spain
Betsi Cadwaladr University Health Board
Bangor Gwynedd, LL57 2PW, United Kingdom
Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
Dorset County Hospital
Dorchester, DT1 2JY, United Kingdom
University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, SE1 9RT, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Mount Vernon Cancer Centre
Northwood, HA6 2RN, United Kingdom
Peterborough City Hospital
Peterborough, PE3 9GZ, United Kingdom
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
Portsmouth, PO6 3LY, United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, TR1 3LJ, United Kingdom
Related Publications (1)
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.
PMID: 33748921DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
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
March 23, 2015
First Posted
March 30, 2015
Study Start
May 6, 2015
Primary Completion
February 22, 2019
Study Completion
February 22, 2019
Last Updated
September 6, 2019
Record last verified: 2019-09