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Breast CancerPhase 3NCT02402712

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

A Phase 3 study testing Docetaxel, pertuzumab [Perjeta] and trastuzumab [Herceptin] in people with Breast Cancer, run by Hoffmann-La Roche at 112 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Docetaxel, pertuzumab [Perjeta] and trastuzumab [Herceptin]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
418 participants
Where
112 sitesin 12 countries
Study dates
6 May 2015to 22 Feb 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

112 sites in 12 countries.

112 sites in 12 countries

Italy21 sites

  • Ospedale Santa Maria Annunziata

    Bagno a Ripoli, Tuscany, 50012

  • Asst Papa Giovanni XXIII

    Bergamo, Lombardy, 24100

  • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

    Catania, Sicily, 95123

  • Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna

    Cona (Ferrara), Veneto, 44124

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50141

  • Ospedale Policlinico San Martino

    Genoa, Liguria, 16132

  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

    Meldola, Emilia-Romagna, 47014

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • Azienda Ospedaliero - Universitaria di Modena Policlinico

    Modena, Emilia-Romagna, 41110

  • Ospedale Sacro Cuore Don Calabria

    Negrar, Veneto, 37024

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128

  • Azienda USL 5 di Pisa

    Pisa, Tuscany, 56100

  • Azienda Ospedaliera Regionale San Carlo

    Potenza, Basilicate, 85100

  • Ospedale Santo Stefano, Azienda USL Centro Prato

    Prato, Tuscany, 59100

  • Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova

    Reggio Emilia, Emilia-Romagna, 42123

  • Ospedale Infermi di Rimini

    Rimini, Emilia-Romagna, 47900

  • Istituti Fisioterapici Ospitalieri

    Rome, Lazio, 00144

  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardy, 20089

  • Asst Della Valtellina E Dell'Alto Lario

    Sondrio, Lombardy, 23100

  • Azienda Ospedaliera Santa Maria di Terni

    Terni, Umbria, 20089

  • "Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"

    Verona, Veneto, 37124

Other trials in Italy

France14 sites

  • Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy

    Ars-Laquenexy, 57530

  • Medipole De Savoie; Departement Oncologie

    Challes-les-Eaux, 73190

  • Hopital Prive Sainte Marie

    Chalon-sur-Saône, 71100

  • Centre Hospitalier Louis Pasteur

    Chartes Le Coudray, 28630

  • Pole Sante Republique; Pharmacie Oncologique

    Clermont-Ferrand, 63050

  • Centre Georges Francois Leclerc

    Dijon, 21000

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble, 38028

  • CHU de Grenoble

    Grenoble, 38043

  • Hopital Europeen

    Marseille, 13003

  • Centre Hospitalier de Mont de Marsan - Hopital Layne

    Mont-de-Marsan, 40024

  • Hopital Saint Joseph; Service de Rhumatologie

    Paris, 75674

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Strasbourg Oncologie Libérale

    Strasbourg, 67000

  • Gustave Roussy

    Villejuif, 94800

Other trials in France

Germany14 sites

  • Studienzentrum Aschaffenburg

    Aschaffenburg, 63739

  • Onkologische Schwerpunktpraxis Dr. Joerg Schilling

    Berlin, 10317

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

  • Kliniken Essen-Mitte

    Essen, 45136

  • Universitätsklinikum Essen

    Essen, 45147

  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

    Freiburg im Breisgau, 79110

  • Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

    Lübeck, 23538

  • Onkologische Schwerpunktpraxis Lübeck

    Lübeck, 23562

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55101

  • Suedharz Klinikum Nordhausen gGmbH

    Nordhausen, 99734

  • Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

    Offenbach, 63069

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

    Stendal, 39576

  • Klinikum Mutterhaus der Borromaeerinnen

    Trier, 54290

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Poland13 sites

  • Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie

    Bialystok, 15-027

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

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

    Gdansk, 80-219

  • Szpitale Pomorskie Sp. z o. o.

    Gdynia, 81-519

  • Przychodnia Lekarska KOMED

    Konin, 625000

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

  • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

    Lublin, 20-090

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

    Olsztyn, 10-228

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej Opolskie Centrum Onkologii

    Opole, 45-061

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

    Poznan, 60-569

  • Wielkopolskie Centrum Onkologii

    Poznan, 61-866

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

    Warsaw, 00-973

  • MAGODENT Sp. z o.o.

    Warsaw, 04-125

Other trials in Poland

United Kingdom10 sites

  • Betsi Cadwaladr University Health Board

    Bangor Gwynedd, LL57 2PW

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • Dorset County Hospital

    Dorchester, DT1 2JY

  • University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Guys and St Thomas NHS Foundation Trust, Guys Hospital

    London, SE1 9RT

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN

  • Peterborough City Hospital

    Peterborough, PE3 9GZ

  • Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital

    Portsmouth, PO6 3LY

  • Royal Cornwall Hospitals NHS Trust

    Truro, TR1 3LJ

Other trials in United Kingdom

Bulgaria7 sites

  • Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC

    Gabrovo, 5300

  • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

    Plovdiv, 4000

  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

    Plovdiv, 4002

  • Comprehensive Cancer Center-Plovdiv

    Plovdiv, 4004

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

    Sofia, 1233

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

    Varna, 9010

  • MDOZS Vrasta Ltd.

    Vratsa, 3000

Other trials in Bulgaria

Hungary7 sites

  • Szent Margit Hospital; Dept. of Oncology

    Budapest, 1032

  • Ogyi, Orszagos Gyogyszereszeti Intezet

    Budapest, 1051

  • Semmelweis Egyetem

    Budapest, 1083

  • Szent Imre Egyetemi Oktatokorhaz

    Budapest, 1115

  • Orszagos Onkologiai Intezet

    Budapest, 1122

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

    Budapest, H-1077

  • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

    Miskolc, 3526

Other trials in Hungary

Spain7 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222

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

    Santiago de Compostela, LA Coruña, 15706

  • Fundacion Instituto Valenciano de Oncologia (IVO)

    Valencia, 46009

Other trials in Spain

Belgium6 sites

  • AZ Sint Jan

    Bruges, 8000

  • UZ Brussel

    Brussels, 1090

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • CHU Sart-Tilman

    Liège, 4000

  • Clinique Saint-Joseph

    Liège, 4000

  • Sint Augustinus Wilrijk

    Wilrijk, 2610

Other trials in Belgium

Mexico6 sites

  • Grupo Medico Camino

    DF, 03310

  • Consultorio de Medicina Especializada

    México, Mexico CITY (federal District), 03100

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

    México, 06760

  • Fundacion de Cancer de Mama.A.C.

    México

  • Centro Medico San Jose

    Monterrey, Nuevo Leon, 64710

  • Cancerología

    Querétaro, 76090

Other trials in Mexico

Portugal5 sites

  • Hospital de Braga

    Braga, 4710-243

  • Instituto Portugues Oncologia de Coimbra Francisco Gentil, EPE

    Coimbra, 3000-075

  • Hospital da Luz

    Lisbon, 1500-650

  • Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria

    Lisbon, 1649-035

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072

Other trials in Portugal

Canada2 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

Other trials in Canada

About this study

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
Being tested
Docetaxel, pertuzumab [Perjeta], trastuzumab [Herceptin]
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

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

  • pertuzumab [Perjeta]Drug

    Also called RO4368451

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

  • trastuzumab [Herceptin]Drug

    Also called RO0452317

    Subcutaneous administration of 600 mg/5 mL every 3 weeks

Study groups in NCT02402712
Study groupRoleWhat they receive
Herceptin SC + Perjeta IV + docetaxel IVExperimentalSingle arm
Receives: Drug: Docetaxel; Drug: pertuzumab [Perjeta]; Drug: trastuzumab [Herceptin]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    Measured: Up to 24 months after the last patient has been enrolled, approximately 3.5 years

  2. Incidence and severity of adverse events Grade >/= 3, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0

    Measured: Up to 24 months after the last patient has been enrolled, approximately 3.5 years

  3. Incidence of cardiac events (composite outcome measure): congestive heart failure (CHF) and cardiac death

    Measured: Up to 24 months after the last patient has been enrolled, approximately 3.5 years

Secondary outcomes (4)

  1. Progression-free survival, tumor assessments according to RECIST v1.1

    Measured: Up to 3.5 years

  2. Overall survival

    Measured: Up to 3.5 years

  3. Objective response rate, defined as a complete response (CR) or a partial response (PR)

    Measured: Up to 3.5 years

  4. Incidence of anti-Herceptin, anti-rHuPH20 antibodies

    Measured: Up to 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2015 (estimated)
  2. Study start6 May 2015
  3. Primary completion22 Feb 2019
  4. Study completion22 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
418 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02402712
Sponsor's protocol ID
BO29159
Other IDs
2014-001458-40, 2014
Status last verified
Sep 2019
First submitted
23 Mar 2015
Last updated
6 Sep 2019
Results posted
No

Publications

  • 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.

    PubMed 33748921

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel, pertuzumab [Perjeta] and trastuzumab [Herceptin] in people with Breast Cancer, run by Hoffmann-La Roche at 112 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in Italy, France, Germany, Poland, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: Up to 24 months after the last patient has been enrolled, approximately 3.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02402712, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.

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