A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.

NCT ID: NCT00545688

Last Updated: 2017-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 417 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-26
• Study Completion Date: 2014-09-22

Brief Summary

This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Herceptin

Intervention Type: DRUG

8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly

Docetaxel

Intervention Type: DRUG

75mg/m2 iv escalating to 100mg/m2 iv 3-weekly

2

Group Type: EXPERIMENTAL

Herceptin

Intervention Type: DRUG

8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly

Docetaxel

Intervention Type: DRUG

75mg/m2 iv escalating to 100mg/m2 iv 3-weekly

Pertuzumab

Intervention Type: DRUG

840mg iv loading dose, followed by 420mg iv 3-weekly

3

Group Type: EXPERIMENTAL

Herceptin

Intervention Type: DRUG

8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly

Pertuzumab

Intervention Type: DRUG

840mg iv loading dose, followed by 420mg iv 3-weekly

4

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

75mg/m2 iv escalating to 100mg/m2 iv 3-weekly

Pertuzumab

Intervention Type: DRUG

840mg iv loading dose, followed by 420mg iv 3-weekly

Interventions

Herceptin

8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly

Intervention Type: DRUG

Docetaxel

75mg/m2 iv escalating to 100mg/m2 iv 3-weekly

Intervention Type: DRUG

Pertuzumab

840mg iv loading dose, followed by 420mg iv 3-weekly

Intervention Type: DRUG

Other Intervention Names

Trastuzumab

Eligibility Criteria

Inclusion Criteria

• female patients, >=18 years of age;
• locally advanced, inflammatory or early stage invasive breast cancer;
• HER2 positive (HER2+++ by IHC or FISH/CISH+).

Exclusion Criteria

• metastatic disease (Stage IV) or bilateral breast cancer;
• previous anticancer therapy or radiotherapy for any malignancy;
• other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
• insulin-dependent diabetes;
• clinically relevant cardiovascular disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Geelong Hospital; Andrew Love Cancer Centre

Geelong, Victoria, Australia

Mount Medical Center

Perth, Western Australia, Australia

Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

Vienna, , Austria

Kaiser Franz Josef Spital; Iii. Medizinische Abt. Mit Onkologie

Vienna, , Austria

Hospital de Caridade de Ijui; Oncologia

Ijuí, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, Brazil

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

Santo André, São Paulo, Brazil

Instituto do Cancer Arnaldo Vieira de Carvalho - ICAVC; Pesquisa Clinica

São Paulo, São Paulo, Brazil

Hospital Perola Byington

São Paulo, São Paulo, Brazil

Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia

São Paulo, São Paulo, Brazil

Instituto de Oncologia de Sorocaba - CEPOS

Sorocaba, São Paulo, Brazil

Moncton Hospital

Moncton, New Brunswick, Canada

Cancer Centre of Southeastern Ontario; Kingston General Hospital

Kingston, Ontario, Canada

University Health Network; Princess Margaret Hospital; Medical Oncology Dept

Toronto, Ontario, Canada

McGill University; Montreal General Hosptial; Oncology

Montreal, Quebec, Canada

CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY

Québec, , Canada

Hadassah Ein Karem Hospital; Oncology Dept

Jerusalem, , Israel

Meir Medical Center; Oncology

Kfar Saba, , Israel

Sourasky / Ichilov Hospital; Dept. of Oncology

Tel Aviv, , Israel

Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli

Bologna, Emilia-Romagna, Italy

Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

Parma, Emilia-Romagna, Italy

Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

Udine, Friuli Venezia Giulia, Italy

ASST OVEST MILANESE; Oncologia Medica

Legnano, Lombardy, Italy

Ospedale San Raffaele, Servizio di Oncologia e Chemioterapia

Milan, Lombardy, Italy

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

Milan, Lombardy, Italy

Ospedale Calvi di Noale; U.O. Complessa di Oncologia ed Ematologia Oncologica

Mirano, Veneto, Italy

Polo Ospedaliero Santorso

Santorso, Veneto, Italy

Ospedale Di Vicenza; Nefrologia, Oncologia Medica

Vicenza, Veneto, Italy

Hospital Miguel Hidalgo

Aguascalientes, , Mexico

ARKE Estudios Clínicos S.A. de C.V.

Mexico City, , Mexico

Issstep Puebla, ; Oncology

Puebla City, , Mexico

Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica

Arequipa, , Peru

Hospital Nacional Edgardo Rebagliati Martins; Oncologia

Lima, , Peru

Samodzielny Publiczny Kliniczny Nr 1 W Lublinie; Klinika Chirurgii Onkologicznej

Lublin, , Poland

COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

Lublin, , Poland

Olsztyński Ośrodek Onkologiczny Kopernik sp. z o.o.

Olsztyn, , Poland

Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

Poznan, , Poland

NZOZ Centrum Medyczne HCP Sp. z o.o.

Poznan, , Poland

Central Hospital of Military School of Medicine; Oncology

Warsaw, , Poland

Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

Warsaw, , Poland

FSBI "Scientific Research Institute of Oncology named after N.N.Petrov" Ministry of Health of RF

Saint Petersburg, Sankt-Peterburg, Russia

SI of Healthcare Kazan Oncology Dispensary

Kazan', , Russia

Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

Moscow, , Russia

NSI of Healthcare Central Clinical Hospital #2 n.a. N.A.Semashko of the Russian Railways

Moscow, , Russia

State Institution Of Healthcare Republican Oncology Dispensary

Petrozavodsk, , Russia

State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary

Pyatigorsk, , Russia

SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF

Ryazan, , Russia

SBI of Healthcare Leningrad Regional Oncology Dispensary

Saint Petersburg, , Russia

SBI of Healthcare Samara Regional Clinical Oncology Dispensary

Samara, , Russia

SI of HealthCare Oncologic Dispensary #2 of department of healthcare of Krasnodar region

Sashi, , Russia

Ulyanovsk Regional Oncology Dispensary; Chemotherapy

Ulyanovsk, , Russia

Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

Seoul, , South Korea

Samsung Medical Centre; Division of Hematology/Oncology

Seoul, , South Korea

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, Spain

Hospital de Cruces; Servicio de Oncologia

Barakaldo, Vizcaya, Spain

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, , Spain

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, , Spain

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, , Spain

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, , Spain

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

Valencia, , Spain

Hospital Universitario Miguel Servet; Servicio Oncologia

Zaragoza, , Spain

Karolinska Hospital; Oncology - Radiumhemmet

Stockholm, , Sweden

Akademiska sjukhuset, Onkologkliniken

Uppsala, , Sweden

Kantonsspital Baden; Frauenklinik

Baden, , Switzerland

Brustzentrum

Zurich, , Switzerland

VETERANS GENERAL HOSPITAL; Department of General Surgery

Taipei, , Taiwan

National Taiwan Uni Hospital; Dept of Oncology

Taipei, , Taiwan

Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

Taipei, , Taiwan

Chulalongkorn Hospital; Medical Oncology

Bangkok, , Thailand

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

Bangkok, , Thailand

Prince of Songkla Uni ; Unit of Medical Oncology

Songkhla, , Thailand

Dokuz Eylul Uni Medical Faculty; Oncology Dept

Izmir, , Turkey (Türkiye)

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sıhhiye, Ankara, , Turkey (Türkiye)

Walsgrave Hospital; Dept of Oncology

Coventry, , United Kingdom

Christie Hospital; Breast Cancer Research Office

Manchester, , United Kingdom

Countries

Australia; Austria; Brazil; Canada; Israel; Italy; Mexico; Peru; Poland; Russia; South Korea; Spain; Sweden; Switzerland; Taiwan; Thailand; Turkey (Türkiye); United Kingdom

References

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Other Identifiers

WO20697

Identifier Type: -

Identifier Source: org_study_id