Trastuzumab & Pertuzumab Followed by T-DM1 in MBC

PHASE2CompletedINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

March 3, 2013

Primary Completion Date

January 11, 2018

Study Completion Date

May 26, 2020

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Trastuzumab

"First administration (loading dose) 8 mg/kg i.v. infusion over 90 min.~\- then every 3 weeks until progression 6 mg/kg i.v. infusion over 30 to 90 min."

DRUG

Pertuzumab

"First administration (loading dose) 840 mg i.v. infusion over 60 min.~\- then every 3 weeks until progression 420 mg i.v. infusion over 30 to 60 min."

DRUG

Paclitaxel

Day 1, 8 and 15; every 4 weeks for ≥4 months 90 mg/m2 i.v. infusion

DRUG

Vinorelbine

"First administration: Day 1 and 8 25 mg/m2 i.v. infusion~* then day 1 and 8, every 3 weeks for ≥4 months 30 mg/m2 i.v. infusion"

DRUG

T-DM1

Every 3 weeks until unacceptable toxicity or progressive disease is observed 3.6 mg/kg i.v. infusion First dose: over 90 min (± 10 min.) Subsequent doses: over 30 min. (± 10 min.)

Trial Locations (71)

1007

VUmc University Medical Center, Amsterdam

1211

Hopitaux Universitaires de Geneve, Geneva

3600

SpitalSTS AG Simmental-Thun-Saanenland, Thun

3900

RSV-GNW Spitalzentrum Oberwallis, Brig

Spitalzentrum Oberwallis, Brig

4031

Universitaetsspital-Basel, Basel

4600

Kantonsspital Olten, Olten

5404

Kantonsspital Baden, Baden

6189

Centre Antoine Lacassagne, Nice

6250

Centre Azureen de Cancerologie, Mougins

6500

Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli, Bellinzona

7000

Kantonsspital Graubuenden, Chur

8091

Universitäts Spital Zürich, Zurich

8401

Kantonsspital Winterthur, Winterthur

8501

Kantonsspital Frauenfeld / Brustzentrum Thurgau, Frauenfeld

9007

Kantonsspital St. Gallen, Sankt Gallen

13003

Fondation Hopital Ambroise Pare - Hopital Europeen, Marseille

13273

Istitut Paoli Calmettes, Marseille

14076

Centre Francois Baclesse, Caen

21079

Centre Georges François Leclerc, Dijon

26953

Centre Hospitalier de Valence, Valence

29200

Hôpital Morvan (Brest), Brest

31059

Institut Claudius Regaud, Toulouse

33076

Institut Bergonie, Bordeaux

34298

Institut Regional du Cancer Montpellier Val d'Aurelle, Montpellier

38043

Hopital Michallon - Centre Hospitalier Universitaire de Grenoble, Grenoble

41016

Centre Hospitalier de Blois, Blois

42271

Institut de Cancerologie de la Loire, Saint-Priest-en-Jarez

44202

Centre Catherine de Sienne, Nantes

44805

ICO - Rene Gauducheau, Saint-Herblain

49933

ICO - Paul Papin, Angers

51726

Institut Jean Godinot, Reims

54100

Polyclinique de Gentilly, Nancy

56322

Centre Hospitalier - Site Hopital du Scorff, Lorient

59020

Centre Oscar Lambret, Lille

64046

Centre Hospitalier de Pau, Pau

66046

Centre Hospitalier de Perpignan - Hopital Saint Jean, Perpignan

67091

Hopitaux Universitaire de Strasbourg - Hopital Civil, Strasbourg

69009

Clinique de la Sauvegarde, Lyon

74130

Centre Hospitalier Alpes Leman, Contamine-sur-Arve

74203

Hopitaux du Leman - Site Georges Pianta, Thonon-les-Bains

75475

Hopital Saint Louis, Paris

76000

Clinique Mathilde, Rouen

76038

Centre Henri Becquerel, Rouen

80054

Hopital Sud - Amiens, Amiens

83007

Centre Hospitalier de Dracenie, Draguignan

84918

Institut Sainte Catherine, Avignon

87042

Chu de Limoges - Hopital Dupuytren, Limoges

89075

Universitäts-Frauenklinik Ulm, Ulm

92210

Curie Site Saint-Cloud, Saint-Cloud

92300

Clinique Hartmann, Levallois-Perret

7609 PP

Almelo_Ziekenhuisgroep Twente, Almelo

1066 CX

Antoni van Leeuwenhoek / Slotervaart hospital, Amsterdam

2625 AD

Reinier de Graaf Gasthuis, Delft

7416 SE

Deventer Ziekenhuis, Deventer

5623 EJ

Catharina Ziekenhuis, Eindhoven

8934 AD

Medisch Centrum Leeuwarden, Leeuwarden

2333 ZA

Leiden_Leids Universitair Medisch Centrum (LUMC), Leiden

3430 EM

St. Antonius Ziekenhuis, Ioc Nieuwegein, Nieuwegein

3045 PM

St. Franciscus Gasthuis Rotterdam, Rotterdam

3118 JH

Vlietland Ziekenhuis, Schiedam

6162 BG

Orbis Medisch Centrum, Sittard

2545 CH

Haga Ziekenhuis, The Hague

CH-5001

Hirslanden Klinik Aarau, Aarau

Kantonspital Aarau, Aarau

CH-3010

Inselspital, Bern, Bern

CH-1011

Centre Hospitalier Universitaire Vaudois CHUV, Lausanne

Centre Hospitalier Universitaire Vaudois, Lausanne

CH-4410

Kantonsspital Liestal, Liestal

CH-6000

Kantonsspital Luzern, Luzerne

CH-9006

Zentrum fuer Tumordiagnostik und Praevention, Sankt Gallen

All Listed Sponsors
lead

Swiss Cancer Institute

OTHER

NCT01835236 - Trastuzumab & Pertuzumab Followed by T-DM1 in MBC | Biotech Hunter | Biotech Hunter