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A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer
- Cancer
- Breast Cancer
- Breast Cancer HER-2 Positive
- Breast Neoplasms
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Cities
- Adana
- Alcorcón
- Alcoy
- Alkmaar
- Amiens
- Ancona
- Angers
- Ankara
- Antalya
- Athens
- Avellino
- Bamberg
- barbastro--huesca
- Barcelona
- Bath
- Bayrut
- Be'er Sheva
- Be'er Ya'akov
- bei-jing-shi
- Beirut
- Beograd
- Bergamo
- Białystok
- Bilbo
- Birmingham
- Bordeaux
- Bourg-en-Bresse
- Brampton
- Bremen
- Bristol
- Budapest
- Burgos
- Cairo Governorate
- Cambridge
- Camperdown
- Caracas
- Cardiff
- Castelló de la Plana
- Cercado de Lima
- Chermside
- Chihuahua
- chong-qing-shi
- Ciudad de México
- Coimbra
- Coventry
- Cáceres
- Debrecen
- Dechy
- Derby
- Dijon
- Dnipro
- Dordrecht
- Durham
- eastbourne
- Edegem
- Edirne
- Edmonton
- Eindhoven
- El Palmar
- Elda
- emilia-romagna
- Erlangen
- Essen
- Esslingen am Neckar
- Firenze
- Frankfurt am Main
- Garran
- Genova
- Gent
- Gera
- Gijón
- Girona
- Glasgow
- Granada
- Graz
- Grimsby
- Groningen
- Guadalajara
- guang-zhou-shi
- Guildford
- Gävle
- Göteborg
- ha-er-bin-shi
- Haifa
- Halifax
- Hamburg
- Hannover
- Heidelberg
- Helsinki
- Holon
- Homburg
- Huddersfield
- Hyères
- Innsbruck
- Islamabad
- İzmir
- Jerez de la Frontera
- Jerusalem
- Jette
- Karlstad
- Kaunas
- Kielce
- Kitchener
- Kraków
- Kyiv
- KZE
- La Chaussée-Saint-Victor
- La Rioja
- Lahore
- Las Palmas de Gran Canaria
- Le Mans
- Leeds
- Leganés
- Legnago
- Leidschendam
- Leuven
- León
- Lille
- Lima
- Limburg an der Lahn
- Limoges
- Linz
- Lisboa
- Ljubljana
- Logroño
- Lombardia
- London
- Longueuil
- Loures
- luik
- Lviv
- Lyon
- Lübeck
- Macclesfield
- Macerata
- Madrid
- Manchester
- Marseille
- Messina
- Middlesbrough
- Milano
- Miraflores
- Miskolc
- Montevideo
- Montréal
- Mougins
- Murcia
- Málaga
- Mönchengladbach
- München
- Nahariya
- nan-jing-shi
- Neuruppin
- Newcastle upon Tyne
- North Vancouver
- Northwood
- Novara
- Otwock
- Ourense
- Oxford
- Palma
- Pamplona
- Paris
- Parkville
- Pavia
- Perpignan
- Petah Tikva
- Peterborough
- Piacenza
- Plymouth
- Ponderano
- Pori
- Porto
- Portoviejo
- puerto-de-sagunto
- Quito
- Rabat
- Ramat Gan
- Ravenna
- Rehovot
- Reims
- Rennes
- Reus
- Rio
- Rio de Janeiro
- Rio Grande do Sul
- Riyadh
- Rotenburg (Wümme)
- Rotterdam
- Saarbrücken
- Sabadell
- Saint-Cloud
- Saint-Grégoire
- Saint-Herblain
- Salamanca
- Salzburg
- Santa Cruz de Tenerife
- Santiago de Compostela
- Santiago de Querétaro
- Sevilla
- shang-hai-shi
- Sidi M'Hamed
- Skåne län
- South Brisbane
- Sremska Kamenica
- Strasbourg
- Sutton
- Szeged
- São Paulo
- Tallinn
- Tampere
- Taormina
- Tartu
- Taunton
- Tel Aviv-Yafo
- Thessaloniki
- tian-jin-shi
- Tilburg
- Torgau
- Toronto
- Toulouse
- Truro
- Turku
- Tübingen
- Udine
- upper-austria
- vaexjoe
- Valence
- Valenciennes
- Valladolid
- València
- Venlo
- Victoria
- Vilnius
- Viterbo
- Västerås
- Warsaw
- Wien
- Wishaw
- xi-an-shi
- Zaporizhzhia
- Zaragoza
- Évora
- Łódź
- أبو ظبي
Trial Identifier:
NCT01572038 2011-005334-20 MO28047
Trial Summary
This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT01572038, MO28047, 2011-005334-20
Trial Identifier
Docetaxel, Nab-paclitaxel, Paclitaxel, Pertuzumab, Trastuzumab
Treatments
Breast Neoplasms
Condition
Official Title
A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection
- HER2-positive breast cancer
- Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- LVEF of at least 50 percent (%)
Exclusion Criteria
- Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease
- Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence less than or equal to (</=) 6 months
- Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
- Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
- History of persistent Grade 2 or higher (National Cancer Institute Common Toxicity Criteria [NCI-CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
- Central nervous system (CNS) metastases
- Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0)
- History of other malignancy within the last 5 years prior to first study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma
- Inadequate bone marrow, liver or renal function
- Uncontrolled hypertension
- Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection
For the latest version of this information please go to www.forpatients.roche.com