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

September 4, 2019 updated by: Hoffmann-La Roche
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

418

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • AZ Sint Jan
      • Brussel, Belgium, 1090
        • UZ Brussel
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • Liège, Belgium, 4000
        • CHU Sart-Tilman
      • Liège, Belgium, 4000
        • Clinique Saint-Joseph
      • Wilrijk, Belgium, 2610
        • Sint Augustinus Wilrijk
  • Bulgaria
      • Gabrovo, Bulgaria, 5300
        • Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC
      • Plovdiv, Bulgaria, 4002
        • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
      • Plovdiv, Bulgaria, 4000
        • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
      • Plovdiv, Bulgaria, 4004
        • Comprehensive Cancer Center-Plovdiv
      • Sofia, Bulgaria, 1233
        • Specialized Hospital For Active Treatment of Oncological Diseases - Sofia District Eood
      • Varna, Bulgaria, 9010
        • Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd
      • Vratsa, Bulgaria, 3000
        • MDOZS Vrasta Ltd.
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Moncton Hospital
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Regional Health Centre
  • France
      • Ars-Laquenexy, France, 57530
        • Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy
      • Challes Les Eaux, France, 73190
        • Medipole De Savoie; Departement Oncologie
      • Chalon sur Saone, France, 71100
        • Hôpital privé sainte Marie
      • Chartes Le Coudray, France, 28630
        • Centre Hospitalier Louis Pasteur
      • Clermont Ferrand, France, 63050
        • Pole Sante Republique; Pharmacie Oncologique
      • Dijon, France, 21000
        • Centre Georges François Leclerc
      • Grenoble, France, 38043
        • CHU de Grenoble
      • Grenoble Cedex, France, 38028
        • Groupe hospitalier mutualiste de Grenoble
      • Marseille, France, 13003
        • Hôpital Européen
      • Mont De Marsan, France, 40024
        • Centre Hospitalier de Mont de Marsan - Hopital Layne
      • Paris, France, 75674
        • Hopital Saint Joseph; Service de Rhumatologie
      • Pierre Benite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Strasbourg, France, 67000
        • Strasbourg Oncologie Libérale
      • Villejuif CEDEX, France, 94800
        • Gustave Roussy
  • Germany
      • Aschaffenburg, Germany, 63739
        • Studienzentrum Aschaffenburg
      • Berlin, Germany, 10317
        • Onkologische Schwerpunktpraxis Dr. Joerg Schilling
      • Erlangen, Germany, 91054
        • Universitaetsklinikum Erlangen
      • Essen, Germany, 45147
        • Universitätsklinikum Essen
      • Essen, Germany, 45136
        • Kliniken Essen-Mitte
      • Freiburg, Germany, 79110
        • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
      • Lubeck, Germany, 23538
        • Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I
      • Lübeck, Germany, 23562
        • Onkologische Schwerpunktpraxis Lübeck
      • Mainz, Germany, 55101
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
      • Nordhausen, Germany, 99734
        • Suedharz Klinikum Nordhausen gGmbH
      • Offenbach, Germany, 63069
        • Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
      • Stendal, Germany, 39576
        • Johanniter-Krankenhaus Genthin - Stendal GmbH; Gynäkologie und gynäkologische Onkologie
      • Trier, Germany, 54290
        • Klinikum Mutterhaus der Borromaeerinnen
      • Wuerzburg, Germany, 97080
        • Universitatsklinikum Wurzburg
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem
      • Budapest, Hungary, 1051
        • Ogyi, Orszagos Gyogyszereszeti Intezet
      • Budapest, Hungary, H-1077
        • Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
      • Budapest, Hungary, 1032
        • Szent Margit Hospital; Dept. of Oncology
      • Budapest, Hungary, 1115
        • Szent Imre Egyetemi Oktatokorhaz
      • Miskolc, Hungary, 3526
        • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
  • Italy
    • Basilicata
      • Potenza, Basilicata, Italy, 85100
        • Azienda Ospedaliera Regionale San Carlo
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Modena, Emilia-Romagna, Italy, 41110
        • Azienda Ospedaliero - Universitaria di Modena Policlinico
      • Reggio Emilia, Emilia-Romagna, Italy, 42123
        • Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova
      • Rimini, Emilia-Romagna, Italy, 47900
        • Ospedale Infermi di Rimini
    • Lazio
      • Roma, Lazio, Italy, 00144
        • Istituti Fisioterapici Ospitalieri
    • Liguria
      • Genova, Liguria, Italy, 16132
        • Ospedale Policlinico San Martino
    • Lombardia
      • Bergamo, Lombardia, Italy, 24100
        • Asst Papa Giovanni XXIII
      • Milano, Lombardia, Italy, 20141
        • Istituto Europeo di Oncologia
      • Rozzano (MI), Lombardia, Italy, 20089
        • Istituto Clinico Humanitas
      • Sondrio, Lombardia, Italy, 23100
        • ASST della Valtellina e dell'Alto Lario
    • Sicilia
      • Catania, Sicilia, Italy, 95123
        • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
    • Toscana
      • Bagno A Ripoli, Toscana, Italy, 50012
        • Ospedale Santa Maria Annunziata
      • Firenze, Toscana, Italy, 50141
        • Azienda Ospedaliera Universitaria Careggi
      • Pisa, Toscana, Italy, 56100
        • Azienda USL 5 di Pisa
      • Prato, Toscana, Italy, 59100
        • Ospedale Santo Stefano, Azienda USL Centro Prato
    • Umbria
      • Terni, Umbria, Italy, 20089
        • Azienda Ospedaliera Santa Maria di Terni
    • Veneto
      • Cona (Ferrara), Veneto, Italy, 44124
        • Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna
      • Negrar, Veneto, Italy, 37024
        • Ospedale Sacro Cuore Don Calabria
      • Padova, Veneto, Italy, 35128
        • Iov - Istituto Oncologico Veneto Irccs
      • Verona, Veneto, Italy, 37124
        • "Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"
  • Mexico
      • DF, Mexico, 03310
        • Grupo Medico Camino
      • Mexico, Mexico, 06760
        • Superare Centro de Infusion S.A. de C.V.
      • Mexico, Mexico
        • Fundacion de Cancer de Mama.A.C.
      • Monterrey, Nuevo Leon, Mexico, 64710
        • Centro Medico San Jose
      • Queretaro, Mexico, 76090
        • Cancerología
    • Mexico CITY (federal District)
      • Mexico, Mexico CITY (federal District), Mexico, 03100
        • Consultorio de Medicina Especializada
  • Poland
      • Bialystok, Poland, 15-027
        • Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie
      • Gdansk, Poland, 80-219
        • Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Gdynia, Poland, 81-519
        • Szpitale Pomorskie Sp. z o. o.
      • Konin, Poland, 625000
        • Przychodnia Lekarska KOMED
      • Krakow, Poland, 31-501
        • Szpital Uniwersytecki w Krakowie
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
      • Olsztyn, Poland, 10-228
        • Samodzielny Publiczny Zakład Opieki Zdrowotnej MSW z W-MCO w Olsztynie
      • Opole, Poland, 45-061
        • Samodzielny Publiczny Zakład Opieki Zdrowotnej Opolskie Centrum Onkologii
      • Poznan, Poland, 61-866
        • Wielkopolskie Centrum Onkologii
      • Poznan, Poland, 60-569
        • Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
      • Warsaw, Poland, 00-973
        • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna
      • Warsaw, Poland, 04-125
        • MAGODENT Sp. z o.o.
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Coimbra, Portugal, 3000-075
        • Instituto Portugues Oncologia de Coimbra Francisco Gentil, EPE
      • Lisboa, Portugal, 1500-650
        • Hospital da Luz
      • Lisboa, Portugal, 1649-035
        • Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
      • Porto, Portugal, 4200-072
        • IPO do Porto; Servico de Oncologia Medica
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda
      • Madrid, Spain, 28040
        • Hospital General Universitario Gregorio Marañon
      • Valencia, Spain, 46009
        • Fundacion Instituto Valenciano de Oncologia (IVO)
    • LA Coruña
      • Santiago de Compostela, LA Coruña, Spain, 15706
        • Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clínico Universitario
  • United Kingdom
      • Bangor Gwynedd, United Kingdom, LL57 2PW
        • Betsi Cadwaladr University Health Board
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre Cancer Centre
      • Dorchester, United Kingdom, DT1 2JY
        • Dorset County Hospital
      • Leicester, United Kingdom, LE1 5WW
        • University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary
      • London, United Kingdom, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust, Guys Hospital
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
      • Northwood, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre
      • Peterborough, United Kingdom, PE3 9GZ
        • Peterborough City Hospital
      • Portsmouth, United Kingdom, PO6 3LY
        • Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
      • Truro, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Herceptin SC + Perjeta IV + docetaxel IV
Single arm
Drug: Docetaxel
Intravenous administration according to local label/clinical practice, after Herceptin and Perjeta.
Drug: pertuzumab [Perjeta]
Intravenous infusion every 3 weeks. First dose: 840 mg. Subsequent doses: 420 mg
Other Names:
  • RO4368451
Drug: trastuzumab [Herceptin]
Subcutaneous administration of 600 mg/5 mL every 3 weeks
Other Names:
  • RO0452317

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs)
Time Frame: Up to 24 months after the last patient has been enrolled, approximately 3.5 years
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
Time Frame: Up to 24 months after the last patient has been enrolled, approximately 3.5 years
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
Time Frame: Up to 24 months after the last patient has been enrolled, approximately 3.5 years
Up to 24 months after the last patient has been enrolled, approximately 3.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Up to 3.5 years
Up to 3.5 years
Progression-free survival, tumor assessments according to RECIST v1.1
Time Frame: Up to 3.5 years
Up to 3.5 years
Objective response rate, defined as a complete response (CR) or a partial response (PR)
Time Frame: Up to 3.5 years
Up to 3.5 years
Incidence of anti-Herceptin, anti-rHuPH20 antibodies
Time Frame: Up to 3.5 years
Up to 3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2015

Primary Completion (Actual)

February 22, 2019

Study Completion (Actual)

February 22, 2019

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 4, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO29159
  • 2014-001458-40 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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