Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT02402712
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 418
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Herceptin SC + Perjeta IV + docetaxel IV trastuzumab [Herceptin] Single arm Herceptin SC + Perjeta IV + docetaxel IV pertuzumab [Perjeta] Single arm Herceptin SC + Perjeta IV + docetaxel IV Docetaxel Single arm
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Progression-free survival, tumor assessments according to RECIST v1.1 Up to 3.5 years Incidence of anti-Herceptin, anti-rHuPH20 antibodies 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
Trial Locations
- Locations (112)
MAGODENT Sp. z o.o.
🇵🇱Warsaw, Poland
Pole Sante Republique; Pharmacie Oncologique
🇫🇷Clermont Ferrand, France
Studienzentrum Aschaffenburg
🇩🇪Aschaffenburg, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
🇩🇪Mainz, Germany
Onkologische Schwerpunktpraxis Lübeck
🇩🇪Lübeck, Germany
Istituto Clinico Humanitas
🇮🇹Rozzano (MI), Lombardia, Italy
Centre Hospitalier Louis Pasteur
🇫🇷Chartes Le Coudray, France
CHU de Grenoble
🇫🇷Grenoble, France
Groupe Hospitalier Mutualiste de Grenoble
🇫🇷Grenoble Cedex, France
Hopital Saint Joseph; Service de Rhumatologie
🇫🇷Paris, France
Klinikum Mutterhaus der Borromaeerinnen
🇩🇪Trier, Germany
Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy
🇫🇷Ars-Laquenexy, France
Centre Georges Francois Leclerc
🇫🇷Dijon, France
Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I
🇩🇪Lubeck, Germany
Royal Victoria Regional Health Centre
🇨🇦Barrie, Ontario, Canada
Universitätsklinikum Essen
🇩🇪Essen, Germany
Suedharz Klinikum Nordhausen gGmbH
🇩🇪Nordhausen, Germany
UZ Brussel
🇧🇪Brussel, Belgium
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
🇧🇬Plovdiv, Bulgaria
Hopital Prive Sainte Marie
🇫🇷Chalon sur Saone, France
Centre Hospitalier de Mont de Marsan - Hopital Layne
🇫🇷Mont De Marsan, France
Strasbourg Oncologie Libérale
🇫🇷Strasbourg, France
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
🇩🇪Offenbach, Germany
Clinique Saint-Joseph
🇧🇪Liège, Belgium
Medipole De Savoie; Departement Oncologie
🇫🇷Challes Les Eaux, France
Hopital Europeen
🇫🇷Marseille, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Gustave Roussy
🇫🇷Villejuif CEDEX, France
Johanniter-Krankenhaus Genthin - Stendal GmbH; Gynäkologie und gynäkologische Onkologie
🇩🇪Stendal, Germany
Universitätsklinikum Würzburg
🇩🇪Wuerzburg, Germany
Universitaetsklinikum Erlangen
🇩🇪Erlangen, Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
🇩🇪Freiburg, Germany
Grupo Medico Camino
🇲🇽DF, Mexico
Velindre Cancer Centre
🇬🇧Cardiff, United Kingdom
Mount Vernon Cancer Centre
🇬🇧Northwood, United Kingdom
Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario
🇪🇸Santiago de Compostela, LA Coruña, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Guys and St Thomas NHS Foundation Trust, Guys Hospital
🇬🇧London, United Kingdom
Fundacion Instituto Valenciano de Oncologia (IVO)
🇪🇸Valencia, Spain
Betsi Cadwaladr University Health Board
🇬🇧Bangor Gwynedd, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Dorset County Hospital
🇬🇧Dorchester, United Kingdom
Peterborough City Hospital
🇬🇧Peterborough, United Kingdom
Hospital Universitario Puerta de Hierro - Majadahonda
🇪🇸Madrid, Spain
University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Azienda Ospedaliera Santa Maria di Terni
🇮🇹Terni, Umbria, Italy
Sint Augustinus Wilrijk
🇧🇪Wilrijk, Belgium
Kliniken Essen-Mitte
🇩🇪Essen, Germany
Orszagos Onkologiai Intezet
🇭🇺Budapest, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
🇭🇺Budapest, Hungary
Instituto Portugues Oncologia de Coimbra Francisco Gentil, EPE
🇵🇹Coimbra, Portugal
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
🇮🇹Meldola, Emilia-Romagna, Italy
Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova
🇮🇹Reggio Emilia, Emilia-Romagna, Italy
Azienda Ospedaliero - Universitaria di Modena Policlinico
🇮🇹Modena, Emilia-Romagna, Italy
Ospedale Infermi di Rimini
🇮🇹Rimini, Emilia-Romagna, Italy
Asst Papa Giovanni XXIII
🇮🇹Bergamo, Lombardia, Italy
Istituto Europeo Di Oncologia
🇮🇹Milano, Lombardia, Italy
Asst Della Valtellina E Dell'Alto Lario
🇮🇹Sondrio, Lombardia, Italy
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
🇮🇹Catania, Sicilia, Italy
Ospedale Santa Maria Annunziata
🇮🇹Bagno A Ripoli, Toscana, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Toscana, Italy
Azienda USL 5 di Pisa
🇮🇹Pisa, Toscana, Italy
Ospedale Santo Stefano, Azienda USL Centro Prato
🇮🇹Prato, Toscana, Italy
Comprehensive Cancer Center-Plovdiv
🇧🇬Plovdiv, Bulgaria
Szent Imre Egyetemi Oktatokorhaz
🇭🇺Budapest, Hungary
AZ Sint Jan
🇧🇪Brugge, Belgium
Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC
🇧🇬Gabrovo, Bulgaria
CHU Sart-Tilman
🇧🇪Liège, Belgium
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
🇧🇬Plovdiv, Bulgaria
Cliniques Universitaires St-Luc
🇧🇪Bruxelles, Belgium
Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District EOOD
🇧🇬Sofia, Bulgaria
MDOZS Vrasta Ltd.
🇧🇬Vratsa, Bulgaria
Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd
🇧🇬Varna, Bulgaria
Szent Margit Hospital; Dept. of Oncology
🇭🇺Budapest, Hungary
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Ogyi, Orszagos Gyogyszereszeti Intezet
🇭🇺Budapest, Hungary
Azienda Ospedaliera Regionale San Carlo
🇮🇹Potenza, Basilicata, Italy
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
🇭🇺Miskolc, Hungary
Superare Centro de Infusion S.A. de C.V.
🇲🇽Mexico, Mexico
Istituti Fisioterapici Ospitalieri
🇮🇹Roma, Lazio, Italy
Ospedale Policlinico San Martino
🇮🇹Genova, Liguria, Italy
Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna
🇮🇹Cona (Ferrara), Veneto, Italy
Centro Medico San Jose
🇲🇽Monterrey, Nuevo Leon, Mexico
Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
🇵🇱Poznan, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna
🇵🇱Warsaw, Poland
IPO do Porto; Servico de Oncologia Medica
🇵🇹Porto, Portugal
Ospedale Sacro Cuore Don Calabria
🇮🇹Negrar, Veneto, Italy
IOV - Istituto Oncologico Veneto IRCCS
🇮🇹Padova, Veneto, Italy
Fundacion de Cancer de Mama.A.C.
🇲🇽Mexico, Mexico
"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"
🇮🇹Verona, Veneto, Italy
Consultorio de Medicina Especializada
🇲🇽Mexico, Mexico CITY (federal District), Mexico
Cancerología
🇲🇽Queretaro, Mexico
Szpitale Pomorskie Sp. z o. o.
🇵🇱Gdynia, Poland
Hospital da Luz
🇵🇹Lisboa, Portugal
Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie
🇵🇱Bialystok, Poland
Szpital Uniwersytecki w Krakowie
🇵🇱Krakow, Poland
Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii
🇵🇱Gdansk, Poland
Przychodnia Lekarska KOMED
🇵🇱Konin, 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
Wielkopolskie Centrum Onkologii
🇵🇱Poznan, Poland
Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
🇵🇹Lisboa, Portugal
Samodzielny Publiczny Zakład Opieki Zdrowotnej Opolskie Centrum Onkologii
🇵🇱Opole, Poland
Hospital de Braga
🇵🇹Braga, Portugal
Onkologische Schwerpunktpraxis Dr. Joerg Schilling
🇩🇪Berlin, Germany
Royal Cornwall Hospitals NHS Trust
🇬🇧Truro, United Kingdom