Breast Cancer Clinical Trial

A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer

Summary

This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line participants with HER2-positive and hormone receptor-positive advanced breast cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the investigator's discretion in combination with the assigned treatment arm. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal of consent, or death whichever occurs first.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants with HER2-positive and hormone receptor-positive advanced metastatic or locally advanced breast cancer
Post-menopausal status over 1 year
HER2-positive as assessed by local laboratory on primary or metastatic tumor
Hormone-receptor positive defined as estrogen receptor-positive and/or progesterone receptor-positive
At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria In Solid Tumors Version 1.1

Exclusion Criteria:

Previous systemic non-hormonal anticancer therapy in the metastatic or locally advanced breast cancer setting
Previous treatment with anti-HER2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting
Disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment
History of persistent Grade 2 or higher hematological toxicity according to National Cancer Institute-Common Toxicity Criteria Version 4.0
Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months
Other malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
Clinical or radiographic evidence of central nervous system metastases or significant cardiovascular disease

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

258

Study ID:

NCT01491737

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 80 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35249, United States
Ironwood Cancer TX & Rsch Ctrs
Chandler Arizona, 85224, United States
Genesis Cancer Center
Hot Springs Arkansas, 71913, United States
Comprehensive Blood & CA Ctr; Research
Bakersfield California, 93309, United States
Rocky Mountain Cancer Center - Denver
Denver Colorado, 80220, United States
Norwalk Hospital
Norwalk Connecticut, 06856, United States
Advanced Medical Specialties
Miami Florida, 33176, United States
Georgia Cancer Specialists - Northside
Atlanta Georgia, 30341, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Marietta Georgia, 30060, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Crescent City Rsrch Cnsrtm, LLC
Marrero Louisiana, 70072, United States
Weinberg CA Inst Franklin Sq
Baltimore Maryland, 21237, United States
Center For Cancer and Blood Disorders
Bethesda Maryland, 20817, United States
Washington University School of Medicine; Internal Medicine - Renal
Saint Louis Missouri, 63110, United States
Hematology Oncology Associates; Carol G. Simon Ctr
Morristown New Jersey, 07960, United States
Cooper Hospital; Hematology & Oncology
Voorhees New Jersey, 08043, United States
NS-Long Island Jewish Hlth Sys
Lake Success New York, 11042, United States
ProHEALTH Care Associates LLP
Lake Success New York, 11042, United States
UPMC Cancer Centers
Pittsburgh Pennsylvania, 15232, United States
Baylor College of Medicine; Lester & Sue Smith Breast Ctr
Houston Texas, 77030, United States
Scott and White Hospital; Cancer Center
Temple Texas, 76508, United States
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo SP, 01246, Brazil
Hospital Perola Byington
Sao Paulo SP, 01317, Brazil
Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia
Sao Paulo SP, 03102, Brazil
Hospital Sao Jose
São Paulo SP, CEP 0, Brazil
HOPITAL JEAN MINJOZ; Oncologie
Besancon , 25030, France
Clinique Tivoli; Sce Radiotherapie
Bordeaux , 33000, France
Hopital Morvan; Oncologie - Radiotherapie
Brest , 29609, France
Centre Jean Perrin; Oncologie
Clermont Ferrand , 63011, France
Clinique De La Sauvegarde; Chimiotherapie
Lyon , 69337, France
Centre Catherine de Sienne; Chimiotherapie
Nantes , 44202, France
Centre Antoine Lacassagne; Hopital De Jour A2
Nice , 06189, France
CH De Senlis; Medecine 2
Senlis , 60309, France
Clinique Pasteur; Oncologie Medicale
Toulouse , 31076, France
Centre Alexis Vautrin; Oncologie Medicale
Vandoeuvre-les-nancy , 54519, France
Indraprastha Apollo Hospitals
New Delhi Delhi, 11007, India
Bangalore Institute of Oncology
Bangalore Karnataka, 56002, India
Jaslok Hospital & Research Centre; Medical Oncology
Mumbai Maharashtra, 40002, India
Apollo Speciality Hospital
Chennai , 60003, India
Ruby Hall Clinic
Pune , 411 0, India
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli Campania, 80131, Italy
Università degli Studi Federico II; Clinica di Oncologia Medica
Napoli Campania, 80131, Italy
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna Emilia-Romagna, 40138, Italy
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
Parma Emilia-Romagna, 43100, Italy
A.O. Santa Maria Degli Angeli; U.O Di Oncologia Medica
Pordenone Friuli-Venezia Giulia, 33170, Italy
Ospedale S.S. Trinità Nuovo; Divisione Oncologia
Sora Lazio, 03039, Italy
Casa di Cura MultiMedica Ospedale di Castellanza; UO Senologia Medica
Castellanza Lombardia, 21053, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milano Lombardia, 20133, Italy
IRCCS Fondazione Maugeri; Oncologia Medica I
Pavia Lombardia, 27100, Italy
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari Puglia, 70124, Italy
Ospedale Antonio Perrino; Oncologia Medica
Brindisi Puglia, 72100, Italy
Ospedale Vito Fazzi; Div. Oncoematologia
Lecce Puglia, 73100, Italy
Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
Catania Sicilia, 95122, Italy
A.O. Careggi; Radioterapia
Firenze Toscana, 50139, Italy
Ospedale Misericordia E Dolce; Oncologia Medica
Prato Toscana, 59100, Italy
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona Barcelona, 08916, Spain
Hospital Provincial de Castellon; Servicio de Oncologia
Castellon de La Plana Castellon, 12002, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba Cordoba, 14004, Spain
IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia
San Sebastian Guipuzcoa, 20014, Spain
Hospital de Donostia; Servicio de Oncologia Medica
San Sebastian Guipuzcoa, 20080, Spain
Hospital del Mar; Servicio de Oncologia
Barcelona , 08003, Spain
Hospital de San Pedro de Alcantara
Caceres , 10003, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
La Coruña , 15006, Spain
Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia
La Coruña , 15009, Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
Lerida , 25198, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid , 28040, Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia , 30120, Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Sevilla , 41009, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia , 46010, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza , 50009, Spain
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Ankara , 06100, Turkey
Ankara City Hospital
Ankara , 06490, Turkey
Ege Uni Medical Faculty Hospital; Oncology Dept
Izmir , 35100, Turkey
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya , 44280, Turkey
Brighton and Sussex Univ Hosp
Brighton , BN2 5, United Kingdom
University Hospital coventry; Oncology Department
Coventry , CV2 2, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
Queen Elizabeth Hospital
London , SE18 , United Kingdom
Queen Alexandra Hospital, Portsmouth
Portsmouth , PO6 3, United Kingdom
Scarborough General Hospital
Scarborough , YO12 , United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield , S10 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

258

Study ID:

NCT01491737

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

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