Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
NEFERTT
A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer
1 other identifier
interventional
479
34 countries
194
Brief Summary
This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Aug 2009
Longer than P75 for phase_2 breast-cancer
194 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2009
CompletedFirst Posted
Study publicly available on registry
June 5, 2009
CompletedStudy Start
First participant enrolled
August 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedResults Posted
Study results publicly available
November 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2018
CompletedAugust 22, 2018
July 1, 2018
3.9 years
June 4, 2009
August 10, 2017
July 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival
Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy.
From randomization to disease progression or death, assessed up to 5.3 years
Secondary Outcomes (4)
Objective Response Rate
From randomization to disease progression or last tumor assessment, assessed up to 5.3 years
Duration of Response
From first response to first PD or death, assessed up to 5.3 years after first subject randomized
Clinical Benefit Rate
From randomization to disease progression or death, assessed up to 5.3 years
Symptomatic or Progressive Central Nervous System (CNS) Lesions
From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 years
Study Arms (2)
neratinib plus paclitaxel
EXPERIMENTALtrastuzumab plus paclitaxel
ACTIVE COMPARATORInterventions
Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel - 80 mg/m² IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Eligibility Criteria
You may qualify if:
- ErbB-2 positive locally recurrent or metastatic breast cancer
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Measurable disease
- Availability of tumor tissue for HER2 status confirmation
You may not qualify if:
- Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease
- Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting
- Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy
- History of heart disease
- History of gastrointestinal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (195)
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030, United States
Redwood Regional Medical Group
Santa Rosa, California, 95403, United States
Cancer Center of Central Connecticut
Plainville, Connecticut, 06062, United States
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, 33435, United States
North Broward Medical Center Cancer Center
Deerfield Beach, Florida, 33064, United States
Broward General Medical Center
Fort Lauderdale, Florida, 33316, United States
Mid Florida Cancer Centers
Orange City, Florida, 32763, United States
Florida Cancer Research Institute
Plantation, Florida, 33324, United States
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Phoebe Cancer Center
Albany, Georgia, 31701, United States
Dublin Hematology and Oncology Care
Dublin, Georgia, 31021, United States
Clintell
Skokie, Illinois, 60077, United States
Presence Hematology and Oncology
Skokie, Illinois, 60077, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
CHRISTUS St. Frances Cabrini Hospital
Alexandria, Louisiana, 71301, United States
Hematology Oncology Services
Metairie, Louisiana, 70006, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, 55426, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
St. John's Medical Research Institute
Springfield, Missouri, 65807, United States
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, 63110, United States
The Valley Hospital, Luckow Pavilion Office of Oncology Clinical Trials
Paramus, New Jersey, 07652, United States
Gaston Hematology and Oncology Associates
Gastonia, North Carolina, 28054, United States
Summa Health System Hospitals
Akron, Ohio, 44304-1619, United States
Warren Cancer Research Foundation
Tulsa, Oklahoma, 74104, United States
Samaritan Hematology and Oncology Consultants
Corvallis, Oregon, 97330, United States
Pawtucket Memorial Hospital
Pawtucket, Rhode Island, 02860, United States
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Santee Hematology Oncology
Sumter, South Carolina, 29150, United States
Tenessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
Family Cancer Care
Memphis, Tennessee, 38120, United States
Texas Oncology
Bedford, Texas, 76022, United States
El Paso Cancer Treatment Center
El Paso, Texas, 79902, United States
Texas Oncology-Allison Cancer Center
Midland, Texas, 79701, United States
Southlake Oncology
Southlake, Texas, 76092, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Charleston Area Medical Center, Health, Education, and Research Institute
Charleston, West Virginia, 25304, United States
The Queen Elizabeth Hospital
North Adelaide, South Australia, 5011, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
N.N. Aleksandrov National Cancer Center of Belarus
Lyasny, Minsk Oblast, 223040, Belarus
Institution of Healthcare Grodno Regional Clinical Hospital
Grodno, 230017, Belarus
Institution Gomel Regional Clinical Oncology Dispensary
Homyel, 246012, Belarus
Healthcare Institution Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, 210603, Belarus
Institut Jules Bordet
Brussels, 1000, Belgium
District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD
Plovdiv, 4004, Bulgaria
District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD
Sofia, 1233, Bulgaria
Specialised Hospital of ActiveTreatment in Oncology, Clinic of Chemotherapy
Sofia, 1756, Bulgaria
Hopital Charles, LeMoyne Le Centre Intégré de Cancérologie de la Montérégie
Greenfield Park, Quebec, J4V 2H1, Canada
Centre Hospitalier Régional de Trois-Rivières
Trois-Rivières, Quebec, G8Z 3R9, Canada
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021, China
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Beijing, 100032, China
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
Beijing, 100071, China
Chinese People's Liberation Army General Hospital
Beijing, 100853, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Tianjin Cancer Hospital
Tianjin, 300060, China
Clinical Hospital Osijek, Department of Radiotherapy and Oncology
Osijek, 31000, Croatia
University Hospital For Tumors
Zagreb, 10000, Croatia
Rigshospitalet, Copenhagen, Onkologisk Klinik
Copenhagen, 2100, Denmark
Hôpital Henri-Mondor
Créteil, 94010, France
Centre Leon Berard Departement de Cancerologie Medicale
Lyon, 69373, France
Centre Val d'Aurelle
Montpellier, 34298, France
Hopital Hotel Dieu, Service d'Oncologie Medicale, Bat B2, 5ieme
Paris, 75181, France
Hopital La Pitie-Salpetriere
Paris, 75651, France
Groupe Hospitalier Paris Saint Joseph, Oncologie medicale
Paris, 75674, France
Service d'Oncologie et de Radiotherapie, Polyclinique Francheville
Périgueux, 24004, France
Clinique Armoricaine de Radiologie
Saint-Brieuc, 22015, France
Centre de Radiothérapie, Clinique Sainte Anne, Service d'Oncologie Libérale
Strasbourg, 67000, France
CHU Strasbourg Departement Oncologie & Hematologie Hopital Civil
Strasbourg, 67091, France
CHU Bretonneau, Centre Henry Kaplan
Tours, 37044, France
Sozialstiftung Bamberg Klinik fuer Haematologie und internistische Onkologie
Bamberg, 96049, Germany
Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
UNIMED Medical Institute, Comprehensive Centre for Breast Diseases
Wan Chai, Hong Kong
Semmelweis Egyetem Radiologiai és Onkoterapias Klinika
Budapest, 1082, Hungary
Fovarosi Onkormanyzat Szent Imre Korhaz Klinikai Onkologiai Profil
Budapest, 1115, Hungary
Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly
Budapest, 1122, Hungary
Kaposi Mor Oktato Korhoz Onkologiai Centrum
Kaposvár, 7400, Hungary
Bacs-Kiskun Megyei Onkormanyzat Korhaza Onkoradiologiai Kozpont
Kecskemét, 6000, Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, 3526, Hungary
Szegedi Tudomanyegyetem Onkoterapias Klinika
Szeged, 6720, Hungary
Jawaharlal Nehru Cancer Hospital
Bhopal, Madhya Pradesh, 462001, India
Tata Memorial Centre
Mumbai, Maharashtra, 400012, India
Central India Cancer Research Institute
Nagpur, Maharashtra, 440010, India
Curie Manavata Cancer Centre
Nashik, Maharashtra, 422004, India
Shatabdi Super Speciality Hospital
Nashilk, Maharashtra, 422005, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411001, India
Institute Rotary Cancer Hospital, AIIMS
New Delhi, National Capital Territory of Delhi, 110029, India
Searoc Cancer Center
Jaipur, Rajasthan, 302013, India
Meenakshi Mission Hospital and Research Centre
Madurai, Tamil Nadu, 625107, India
B P Poddar and Medical Research Ltd.
Kolkata, West Bengal, 700053, India
Kaplan Medical Center
Rehovot, 76101, Israel
Sourasky Medical Center
Tel Aviv, 64239, Israel
Assaf Harofeh Medical Center
Ẕerifin, 60930, Israel
Policlinico di Modena Oncologia ed Ematologia
Modena, 41100, Italy
Fondazione Salvatore Maugeri
Pavia, 27100, Italy
Policlinico Universitario Campus Bio-Medico
Roma, 00128, Italy
Ospedale San Pietro Fatebenefratelli
Roma, 00189, Italy
Ospedale San Giovanni Battista-Molinette
Torino, 10126, Italy
Hyogo Cancer Center
Hyōgo, Akashi-shi, 673-8558, Japan
National Hospital Organization Beppu Medical Center
Ōita, Beppu-shi, 874-0011, Japan
Tokyo Metropolitan Cancer and Infectious Disease Center, Komagome Hospital
Tokyo, Bunkyo-ku, 113-8677, Japan
Chiba Cancer Center
Chiba, Chiba-shi, 260-8717, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka-shi, 811-1395, Japan
National Hospital Organization Mito Medical Center
Ibaraki, Higashiibaraki-gun, 311-3193, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima-shi, 734-8551, Japan
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima, Kagoshima-city, 892-0833, Japan
National Cancer Center Hospital East
Chiba, Kashiwa-shi, 277-8577, Japan
Saitama Cancer Center
Saitama, Kitaadachi-gun, 362-0806, Japan
Kumamoto Municipal Hospital
Kumamoto, Kumamoto-city, 862-8505, Japan
Kurume Daiichi Social Insurance Hospital
Fukuoka, Kurume-Shi, 830-0013, Japan
National Hospital Organization Shikoku Cancer Center
Ehime, Matsuyama-city, 791-0280, Japan
Iwate Medical University Hospital
Numakunai, Morioka-shi, 020-8505, Japan
Aichi Cancer Center
Aichi, Nagoya-shi, 464-8681, Japan
National Hospital Organization Nagoya Medical Center
Aichi, Nagoya, 460-0001, Japan
Niigata Cancer Center Hospital
Niigata, Niigata-shi, 951-8566, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Osaka-shi, 537-8511, Japan
National Hospital Organization Osaka National Hospital
Osaka, Osaka-shi, 540-0006, Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido, Sapporo-shi, 003-0804, Japan
Tohoku University Hospital
Miyagi, Sendai-city, 980-8574, Japan
Tenri Hospital
Nara, Tenri-shi, 632-8552, Japan
Kanagawa Cancer Center
Kanagawa, Yokohama-City, 241-0815, Japan
Hiroshima City Hospital
Hiroshima, 730-8518, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Hiroshima, 737-0023, Japan
Kobe City Medical Center General Hospital
Hyōgo, 650-0047, Japan
Shinko Hospital
Hyōgo, 651-0072, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Tazuke Kofukai Medical Research Institute Kitano Hospital
Osaka, 530-8480, Japan
Osaka University Hospital
Osaka, 565-0871, Japan
Jichi Medical University Hospital
Tochigi, 329-0498, Japan
Toranomon Hospital
Tokyo, 105-8470, Japan
National Hospital Organization Tokyo Medical Center
Tokyo, 152-8902, Japan
Piejuras Hospital, Liepajas Oncological Clinic
Liepāja, LV-3401, Latvia
Pauls Stradiņš Clinical University Hospital
Riga, LV - 1002, Latvia
Riga Eastern University Hospital
Riga, LV-1079, Latvia
Hospital of Lithuanian University of Health sciences
Kaunas, LT 45434, Lithuania
Nacionalinis Vezio Institutas, Vilniaus Universiteto Onkologijos Institutas
Vilnius, LT-08660, Lithuania
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Sir Anthony Oncology Center
Floriana, VLT 14, Malta
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial
Jelenia Góra, Lower Silesian Voivodeship, 58-506, Poland
Magodent
Warsaw, Masovian Voivodeship, 04125, Poland
Opolskie Centrum Onkologii
Opole, Opole Voivodeship, 45061, Poland
Zakład Opieki Zdrowotnej MSW z Warmińsko, Mazurskim Centrum Onkologii
Olsztyn, Warmian-Masurian Voivodeship, 10228, Poland
Białostockie Centrum Onkologii
Bialystok, 15027, Poland
Hospital da Luz Servico de Oncologia Medica
Lisbon, 1500-650, Portugal
Institutul Oncologic Prof. Dr. Ion Chiricuţă
Cluj-Napoca, Cluj, 400015, Romania
SC Oncolab S.R.L.
Craiova, Dolj, 200385, Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098, Romania
Institute of Oncology and Radiology of Serbia
Belgrade, 11000, Serbia
Clinical centre Nis Clinic of Oncology
Niš, 18000, Serbia
National University Hospital, National Cancer Institute
Singapore, 119082, Singapore
National Cancer Centre Singapore
Singapore, 169610, Singapore
GVI Oncology
Port Elizabeth, Eastern Cape, 6045, South Africa
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, 2196, South Africa
University of Witwatersrand Oncology, Donald Gordon Medical Centre
Johannesburg, Gauteng, 2197, South Africa
Sandton Oncology Centre
Johannesburg, Gauteng, 2199, South Africa
Eastleigh Breast Care Centre
Pretoria, Gauteng, 0081, South Africa
Westridge Medical Centre
Durban, KwaZulu-Natal, 4001, South Africa
GVI Oncology
Kraaifontein, Western Cape, 7570, South Africa
National Cancer Center, Center for Breast Cancer
Goyang-si, Gyeonggi-do, 410-769, South Korea
Samsung Medical Center
Seoul, Korea, 135-710, South Korea
Asan Medical Center
Seoul, Korea, 138-736, South Korea
Korea University Guro Hospital
Seoul, Korea, 152-703, South Korea
Yonsei University Health System Severance Hospital
Seoul, Seoul/Korea, 120-752, South Korea
Hospital Son Llàtzer
Palma, Balearic Islands, 07198, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Catalonia, 25198, Spain
Complejo Hospitalario Universitario Santiago de Compostela
Santiago de Compostela, Galicia, 15706, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922, Spain
Hospital Puerta De Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Infanta Cristina
Parla, Madrid, 28981, Spain
Hospital Madrid Norte Sanchinarro Centro Integral Oncológico Clara Campal Ensayos Clínicos
PAU de Sanchinarro, Madrid, 28050, Spain
Hospital Costa del Sol
Marbella, Malaga, 29603, Spain
Hospital de Cruces
Barakaldo, Vizcaya, 48903, Spain
Centro Oncologico MD Anderson
Madrid, 28033, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Tumor Center Hirslanden Medical Center
Aarau, 5000, Switzerland
Spital STS AG Onkologiezentrum Thun - Berner Oberland
Thun, 3600, Switzerland
Kantonsspital Winterthur Medizinische Onkologie
Winterthur, 8401, Switzerland
Chang Gung Medical Foundation, Linkou Branch
Taoyuan District, 333, Taiwan
Affinity Research Limited
Nassau, CB, 13932, The Bahamas
Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi
Bornova, İzmir, 35040, Turkey (Türkiye)
Komunalnyy Zaklad Cherkasskyy Oblasnyy Onkologichnyy Dyspanser
Cherkassy, 18009, Ukraine
Chernivtsi Regional Oncology Centre Outpatient Department Bukovynian State Medical University Department of Oncology and Radiology
Chernivtsi, 58013, Ukraine
City Multifield Clinical Hospital
Dnipropetrovsk, 49102, Ukraine
Donetsk Regional Antitumor Center Department of Pretumor Diseases and Tumor Treatment
Donetsk, 83092, Ukraine
S.P. Grigoreva Institute of Medical Radiology Department of Chemotherapy
Kharkiv, 61024, Ukraine
National Institute of Cancer Department of Conseravtive Methods of Treatment
Kyiv, 03022, Ukraine
Volyn Regional Oncological Center
Lutsk, 63000, Ukraine
State Oncological Regional Treatment and Diagnostic Center
Lviv, 79031, Ukraine
Mariupil Oncological Center
Mariupil, 87500, Ukraine
Sumy Regional Clinical Oncology Centre
Sumy, 40005, Ukraine
Guy's and St Thomas NHS Foundation Trust Management Offices 4th Floor Bermondsey Wing Guy's Hospital
London, SE1 9RT, United Kingdom
Nottingham University Hospital
Nottingham, NG5 1PB, United Kingdom
Related Publications (1)
Awada A, Colomer R, Inoue K, Bondarenko I, Badwe RA, Demetriou G, Lee SC, Mehta AO, Kim SB, Bachelot T, Goswami C, Deo S, Bose R, Wong A, Xu F, Yao B, Bryce R, Carey LA. Neratinib Plus Paclitaxel vs Trastuzumab Plus Paclitaxel in Previously Untreated Metastatic ERBB2-Positive Breast Cancer: The NEfERT-T Randomized Clinical Trial. JAMA Oncol. 2016 Dec 1;2(12):1557-1564. doi: 10.1001/jamaoncol.2016.0237.
PMID: 27078022DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Clinical Operations
- Organization
- Puma Biotechnology, Inc.
Study Officials
- STUDY DIRECTOR
Puma
Biotechnology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2009
First Posted
June 5, 2009
Study Start
August 21, 2009
Primary Completion
August 1, 2013
Study Completion
June 28, 2018
Last Updated
August 22, 2018
Results First Posted
November 6, 2017
Record last verified: 2018-07