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
NCT ID: NCT01491737
Last Updated: 2020-10-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
258 participants
INTERVENTIONAL
2012-02-17
2019-11-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Pertuzumab + Trastuzumab + AI +/- Chemotherapy
Participants will receive pertuzumab in combination with trastuzumab plus aromatase inhibitor (AI) until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Participants may also receive induction chemotherapy (docetaxel every 3 weeks or paclitaxel weekly) up to the first 18-24 weeks of the treatment period at the investigator's discretion.
Pertuzumab
Participants will receive a loading dose of 840 milligrams (mg) as an intravenous infusion on Day 1 of first treatment cycle, followed by 420 mg on Day 1 or Day 2 of each subsequent 3-week cycle until disease progression or unacceptable toxicity.
Trastuzumab
Participants will receive a loading dose of 8 milligrams per kilogram (mg/kg) as an intravenous infusion on Day 1 or 2 of first treatment cycle, followed by 6 mg/kg on Day 1 or Day 2 of each subsequent treatment 3-week cycles until disease progression or unacceptable toxicity.
Aromatase Inhibitor
Participants will receive 1 mg anastrozole or 2.5 mg letrozole orally once daily.
Induction Chemotherapy
Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period will receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective pertuzumab and/or trastuzumab infusions at the investigator's discretion.
Arm B: Trastuzumab + AI +/- Chemotherapy
Participants will receive trastuzumab plus aromatase inhibitor (AI) until predefined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Participants may also receive induction chemotherapy (docetaxel every 3 weeks or paclitaxel weekly) up to the first 18-24 weeks of the treatment period at the investigator's discretion.
Trastuzumab
Participants will receive a loading dose of 8 milligrams per kilogram (mg/kg) as an intravenous infusion on Day 1 or 2 of first treatment cycle, followed by 6 mg/kg on Day 1 or Day 2 of each subsequent treatment 3-week cycles until disease progression or unacceptable toxicity.
Aromatase Inhibitor
Participants will receive 1 mg anastrozole or 2.5 mg letrozole orally once daily.
Induction Chemotherapy
Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period will receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective pertuzumab and/or trastuzumab infusions at the investigator's discretion.
Interventions
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Pertuzumab
Participants will receive a loading dose of 840 milligrams (mg) as an intravenous infusion on Day 1 of first treatment cycle, followed by 420 mg on Day 1 or Day 2 of each subsequent 3-week cycle until disease progression or unacceptable toxicity.
Trastuzumab
Participants will receive a loading dose of 8 milligrams per kilogram (mg/kg) as an intravenous infusion on Day 1 or 2 of first treatment cycle, followed by 6 mg/kg on Day 1 or Day 2 of each subsequent treatment 3-week cycles until disease progression or unacceptable toxicity.
Aromatase Inhibitor
Participants will receive 1 mg anastrozole or 2.5 mg letrozole orally once daily.
Induction Chemotherapy
Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period will receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective pertuzumab and/or trastuzumab infusions at the investigator's discretion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Ironwood Cancer TX & Rsch Ctrs
Chandler, Arizona, United States
Genesis Cancer Center
Hot Springs, Arkansas, United States
Comprehensive Blood & CA Ctr; Research
Bakersfield, California, United States
Rocky Mountain Cancer Center - Denver
Denver, Colorado, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Advanced Medical Specialties
Miami, Florida, United States
Georgia Cancer Specialists - Northside
Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Marietta, Georgia, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Crescent City Rsrch Cnsrtm, LLC
Marrero, Louisiana, United States
Weinberg CA Inst Franklin Sq
Baltimore, Maryland, United States
Center For Cancer and Blood Disorders
Bethesda, Maryland, United States
Washington University School of Medicine; Internal Medicine - Renal
St Louis, Missouri, United States
Hematology Oncology Associates; Carol G. Simon Ctr
Morristown, New Jersey, United States
Cooper Hospital; Hematology & Oncology
Voorhees Township, New Jersey, United States
NS-Long Island Jewish Hlth Sys
Lake Success, New York, United States
ProHEALTH Care Associates LLP
Lake Success, New York, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine; Lester & Sue Smith Breast Ctr
Houston, Texas, United States
Scott and White Hospital; Cancer Center
Temple, Texas, United States
Instituto do Cancer do Estado de Sao Paulo - ICESP
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
Hospital Sao Jose
São Paulo, São Paulo, Brazil
HOPITAL JEAN MINJOZ; Oncologie
Besançon, , France
Clinique Tivoli; Sce Radiotherapie
Bordeaux, , France
Hopital Morvan; Oncologie - Radiotherapie
Brest, , France
Centre Jean Perrin; Oncologie
Clermont-Ferrand, , France
Clinique De La Sauvegarde; Chimiotherapie
Lyon, , France
Centre Catherine de Sienne; Chimiotherapie
Nantes, , France
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, , France
CH De Senlis; Medecine 2
Senlis, , France
Clinique Pasteur; Oncologie Medicale
Toulouse, , France
Centre Alexis Vautrin; Oncologie Medicale
Vandœuvre-lès-Nancy, , France
Bangalore Institute of Oncology
Bangalore, Karnataka, India
Jaslok Hospital & Research Centre; Medical Oncology
Mumbai, Maharashtra, India
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, India
Apollo Speciality Hospital
Chennai, , India
Ruby Hall Clinic
Pune, , India
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari, Apulia, Italy
Ospedale Antonio Perrino; Oncologia Medica
Brindisi, Apulia, Italy
Ospedale Vito Fazzi; Div. Oncoematologia
Lecce, Apulia, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, Italy
Università degli Studi Federico II; Clinica di Oncologia Medica
Napoli, Campania, Italy
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna, Emilia-Romagna, Italy
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
Parma, Emilia-Romagna, Italy
A.O. Santa Maria Degli Angeli; U.O Di Oncologia Medica
Pordenone, Friuli Venezia Giulia, Italy
Ospedale S.S. Trinità Nuovo; Divisione Oncologia
Sora, Lazio, Italy
Casa di Cura MultiMedica Ospedale di Castellanza; UO Senologia Medica
Castellanza, Lombardy, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milan, Lombardy, Italy
IRCCS Fondazione Maugeri; Oncologia Medica I
Pavia, Lombardy, Italy
Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
Catania, Sicily, Italy
A.O. Careggi; Radioterapia
Florence, Tuscany, Italy
Ospedale Misericordia E Dolce; Oncologia Medica
Prato, Tuscany, Italy
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona, Barcelona, Spain
Hospital Provincial de Castellon; Servicio de Oncologia
Castellon, Castellon, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, Spain
IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia
Donostia / San Sebastian, Guipuzcoa, Spain
Hospital de Donostia; Servicio de Oncologia Medica
Donostia / San Sebastian, Guipuzcoa, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
A Coruña, , Spain
Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia
A Coruña, , Spain
Hospital del Mar; Servicio de Oncologia
Barcelona, , Spain
Hospital de San Pedro de Alcantara
Cáceres, , Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
Lleida, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Seville, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, , Spain
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Ankara, , Turkey (Türkiye)
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Ege Uni Medical Faculty Hospital; Oncology Dept
Izmir, , Turkey (Türkiye)
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya, , Turkey (Türkiye)
Brighton and Sussex Univ Hosp
Brighton, , United Kingdom
University Hospital coventry; Oncology Department
Coventry, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Queen Elizabeth Hospital
London, , United Kingdom
Queen Alexandra Hospital, Portsmouth
Portsmouth, , United Kingdom
Scarborough General Hospital
Scarborough, , United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield, , United Kingdom
Countries
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References
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Rimawi M, Ferrero JM, de la Haba-Rodriguez J, Poole C, De Placido S, Osborne CK, Hegg R, Easton V, Wohlfarth C, Arpino G; PERTAIN Study Group. First-Line Trastuzumab Plus an Aromatase Inhibitor, With or Without Pertuzumab, in Human Epidermal Growth Factor Receptor 2-Positive and Hormone Receptor-Positive Metastatic or Locally Advanced Breast Cancer (PERTAIN): A Randomized, Open-Label Phase II Trial. J Clin Oncol. 2018 Oct 1;36(28):2826-2835. doi: 10.1200/JCO.2017.76.7863. Epub 2018 Aug 14.
Other Identifiers
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2011-002132-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO27775
Identifier Type: -
Identifier Source: org_study_id