Breast CancerPhase 2NEFERTTNCT00915018
Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
A Phase 2 study testing Neratinib, Trastuzumab and Paclitaxel in people with Breast Cancer, run by Puma Biotechnology, Inc. at 195 sites in 35 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Neratinib, Trastuzumab and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 479 participants
- Where
- 195 sitesin 35 countries
- Study dates
- 21 Aug 2009to 28 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
195 sites in 35 countries.
195 sites in 35 countries
United States36 sites
Summa Health System Hospitals
Akron, Ohio, 44304-1619
Phoebe Cancer Center
Albany, Georgia, 31701
CHRISTUS St. Frances Cabrini Hospital
Alexandria, Louisiana, 71301
Texas Oncology
Bedford, Texas, 76022
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, 33435
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, 29425
Charleston Area Medical Center, Health, Education, and Research Institute
Charleston, West Virginia, 25304
Missouri Cancer Associates
Columbia, Missouri, 65201
Samaritan Hematology and Oncology Consultants
Corvallis, Oregon, 97330
North Broward Medical Center Cancer Center
Deerfield Beach, Florida, 33064
Dublin Hematology and Oncology Care
Dublin, Georgia, 31021
El Paso Cancer Treatment Center
El Paso, Texas, 79902
Broward General Medical Center
Fort Lauderdale, Florida, 33316
Gaston Hematology and Oncology Associates
Gastonia, North Carolina, 28054
Tenessee Cancer Specialists
Knoxville, Tennessee, 37909
Family Cancer Care
Memphis, Tennessee, 38120
Hematology Oncology Services
Metairie, Louisiana, 70006
Texas Oncology-Allison Cancer Center
Midland, Texas, 79701
Mid Florida Cancer Centers
Orange City, Florida, 32763
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030
The Valley Hospital, Luckow Pavilion Office of Oncology Clinical Trials
Paramus, New Jersey, 07652
Pawtucket Memorial Hospital
Pawtucket, Rhode Island, 02860
Cancer Center of Central Connecticut
Plainville, Connecticut, 06062
Florida Cancer Research Institute
Plantation, Florida, 33324
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, 34952
Park Nicollet Institute
Saint Louis Park, Minnesota, 55426
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Redwood Regional Medical Group
Santa Rosa, California, 95403
Clintell
Skokie, Illinois, 60077
Presence Hematology and Oncology
Skokie, Illinois, 60077
Southlake Oncology
Southlake, Texas, 76092
Springfield Clinic
Springfield, Illinois, 62703
St. John's Medical Research Institute
Springfield, Missouri, 65807
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, 63110
Santee Hematology Oncology
Sumter, South Carolina, 29150
Warren Cancer Research Foundation
Tulsa, Oklahoma, 74104
Japan33 sites
Aichi Cancer Center
Aichi, Nagoya-shi, 464-8681
National Hospital Organization Nagoya Medical Center
Aichi, Nagoya, 460-0001
Chiba Cancer Center
Chiba, Chiba-shi, 260-8717
National Cancer Center Hospital East
Chiba, Kashiwa-shi, 277-8577
National Hospital Organization Shikoku Cancer Center
Ehime, Matsuyama-city, 791-0280
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka-shi, 811-1395
Kurume Daiichi Social Insurance Hospital
Fukuoka, Kurume-Shi, 830-0013
Hiroshima University Hospital
Hiroshima, Hiroshima-shi, 734-8551
Hiroshima City Hospital
Hiroshima, 730-8518
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Hiroshima, 737-0023
National Hospital Organization Hokkaido Cancer Center
Hokkaido, Sapporo-shi, 003-0804
Hyogo Cancer Center
Hyōgo, Akashi-shi, 673-8558
Kobe City Medical Center General Hospital
Hyōgo, 650-0047
Shinko Hospital
Hyōgo, 651-0072
National Hospital Organization Mito Medical Center
Ibaraki, Higashiibaraki-gun, 311-3193
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima, Kagoshima-city, 892-0833
Kanagawa Cancer Center
Kanagawa, Yokohama-City, 241-0815
Kumamoto Municipal Hospital
Kumamoto, Kumamoto-city, 862-8505
Kumamoto University Hospital
Kumamoto, 860-8556
Tohoku University Hospital
Miyagi, Sendai-city, 980-8574
Tenri Hospital
Nara, Tenri-shi, 632-8552
Niigata Cancer Center Hospital
Niigata, Niigata-shi, 951-8566
Iwate Medical University Hospital
Numakunai, Morioka-shi, 020-8505
National Hospital Organization Beppu Medical Center
Ōita, Beppu-shi, 874-0011
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Osaka-shi, 537-8511
National Hospital Organization Osaka National Hospital
Osaka, Osaka-shi, 540-0006
Tazuke Kofukai Medical Research Institute Kitano Hospital
Osaka, 530-8480
Osaka University Hospital
Osaka, 565-0871
Saitama Cancer Center
Saitama, Kitaadachi-gun, 362-0806
Jichi Medical University Hospital
Tochigi, 329-0498
Tokyo Metropolitan Cancer and Infectious Disease Center, Komagome Hospital
Tokyo, Bunkyo-ku, 113-8677
Toranomon Hospital
Tokyo, 105-8470
National Hospital Organization Tokyo Medical Center
Tokyo, 152-8902
Spain12 sites
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Hospital de Cruces
Barakaldo, Vizcaya, 48903
Hospital Universitari Arnau de Vilanova
Lleida, Catalonia, 25198
Centro Oncologico MD Anderson
Madrid, 28033
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Puerta De Hierro
Majadahonda, Madrid, 28222
Hospital Costa del Sol
Marbella, Malaga, 29603
Hospital Son Llàtzer
Palma, Balearic Islands, 07198
Hospital Universitario Infanta Cristina
Parla, Madrid, 28981
Hospital Madrid Norte Sanchinarro Centro Integral Oncológico Clara Campal Ensayos Clínicos
PAU de Sanchinarro, Madrid, 28050
Complejo Hospitalario Universitario Santiago de Compostela
Santiago de Compostela, Galicia, 15706
France11 sites
Hôpital Henri-Mondor
Créteil, 94010
Centre Leon Berard Departement de Cancerologie Medicale
Lyon, 69373
Centre Val d'Aurelle
Montpellier, 34298
Hopital Hotel Dieu, Service d'Oncologie Medicale, Bat B2, 5ieme
Paris, 75181
Hopital La Pitie-Salpetriere
Paris, 75651
Groupe Hospitalier Paris Saint Joseph, Oncologie medicale
Paris, 75674
Service d'Oncologie et de Radiotherapie, Polyclinique Francheville
Périgueux, 24004
Clinique Armoricaine de Radiologie
Saint-Brieuc, 22015
Centre de Radiothérapie, Clinique Sainte Anne, Service d'Oncologie Libérale
Strasbourg, 67000
CHU Strasbourg Departement Oncologie & Hematologie Hopital Civil
Strasbourg, 67091
CHU Bretonneau, Centre Henry Kaplan
Tours, 37044
India10 sites
Jawaharlal Nehru Cancer Hospital
Bhopal, Madhya Pradesh, 462001
Searoc Cancer Center
Jaipur, Rajasthan, 302013
B P Poddar and Medical Research Ltd.
Kolkata, West Bengal, 700053
Meenakshi Mission Hospital and Research Centre
Madurai, Tamil Nadu, 625107
Tata Memorial Centre
Mumbai, Maharashtra, 400012
Central India Cancer Research Institute
Nagpur, Maharashtra, 440010
Curie Manavata Cancer Centre
Nashik, Maharashtra, 422004
Shatabdi Super Speciality Hospital
Nashilk, Maharashtra, 422005
Institute Rotary Cancer Hospital, AIIMS
New Delhi, National Capital Territory of Delhi, 110029
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411001
Ukraine10 sites
Komunalnyy Zaklad Cherkasskyy Oblasnyy Onkologichnyy Dyspanser
Cherkassy, 18009
Chernivtsi Regional Oncology Centre Outpatient Department Bukovynian State Medical University Department of Oncology and Radiology
Chernivtsi, 58013
City Multifield Clinical Hospital
Dnipropetrovsk, 49102
Donetsk Regional Antitumor Center Department of Pretumor Diseases and Tumor Treatment
Donetsk, 83092
S.P. Grigoreva Institute of Medical Radiology Department of Chemotherapy
Kharkiv, 61024
National Institute of Cancer Department of Conseravtive Methods of Treatment
Kyiv, 03022
Volyn Regional Oncological Center
Lutsk, 63000
State Oncological Regional Treatment and Diagnostic Center
Lviv, 79031
Mariupil Oncological Center
Mariupil, 87500
Sumy Regional Clinical Oncology Centre
Sumy, 40005
China9 sites
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Beijing, 100032
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
Beijing, 100071
Chinese People's Liberation Army General Hospital
Beijing, 100853
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Fudan University Shanghai Cancer Center
Shanghai, 200032
Tianjin Cancer Hospital
Tianjin, 300060
Hungary7 sites
Semmelweis Egyetem Radiologiai és Onkoterapias Klinika
Budapest, 1082
Fovarosi Onkormanyzat Szent Imre Korhaz Klinikai Onkologiai Profil
Budapest, 1115
Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly
Budapest, 1122
Kaposi Mor Oktato Korhoz Onkologiai Centrum
Kaposvár, 7400
Bacs-Kiskun Megyei Onkormanyzat Korhaza Onkoradiologiai Kozpont
Kecskemét, 6000
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, 3526
Szegedi Tudomanyegyetem Onkoterapias Klinika
Szeged, 6720
South Africa7 sites
Westridge Medical Centre
Durban, KwaZulu-Natal, 4001
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, 2196
University of Witwatersrand Oncology, Donald Gordon Medical Centre
Johannesburg, Gauteng, 2197
Sandton Oncology Centre
Johannesburg, Gauteng, 2199
GVI Oncology
Kraaifontein, Western Cape, 7570
GVI Oncology
Port Elizabeth, Eastern Cape, 6045
Eastleigh Breast Care Centre
Pretoria, Gauteng, 0081
Italy5 sites
Policlinico di Modena Oncologia ed Ematologia
Modena, 41100
Fondazione Salvatore Maugeri
Pavia, 27100
Policlinico Universitario Campus Bio-Medico
Roma, 00128
Ospedale San Pietro Fatebenefratelli
Roma, 00189
Ospedale San Giovanni Battista-Molinette
Torino, 10126
Poland5 sites
Białostockie Centrum Onkologii
Bialystok, 15027
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial
Jelenia Góra, Lower Silesian Voivodeship, 58-506
Zakład Opieki Zdrowotnej MSW z Warmińsko, Mazurskim Centrum Onkologii
Olsztyn, Warmian-Masurian Voivodeship, 10228
Opolskie Centrum Onkologii
Opole, Opole Voivodeship, 45061
Magodent
Warsaw, Masovian Voivodeship, 04125
South Korea5 sites
National Cancer Center, Center for Breast Cancer
Goyang-si, Gyeonggi-do, 410-769
Samsung Medical Center
Seoul, Korea, 135-710
Asan Medical Center
Seoul, Korea, 138-736
Korea University Guro Hospital
Seoul, Korea, 152-703
Yonsei University Health System Severance Hospital
Seoul, Seoul/Korea, 120-752
Belarus4 sites
Institution of Healthcare Grodno Regional Clinical Hospital
Grodno, 230017
Institution Gomel Regional Clinical Oncology Dispensary
Homyel, 246012
N.N. Aleksandrov National Cancer Center of Belarus
Lyasny, Minsk Oblast, 223040
Healthcare Institution Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, 210603
Bulgaria3 sites
District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD
Plovdiv, 4004
District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD
Sofia, 1233
Specialised Hospital of ActiveTreatment in Oncology, Clinic of Chemotherapy
Sofia, 1756
Hong Kong3 sites
Pamela Youde Nethersole Eastern Hospital
Chai Wan
Queen Mary Hospital
Hong Kong
UNIMED Medical Institute, Comprehensive Centre for Breast Diseases
Wan Chai
Israel3 sites
Kaplan Medical Center
Rehovot, 76101
Sourasky Medical Center
Tel Aviv, 64239
Assaf Harofeh Medical Center
Tsrifin, 60930
Latvia3 sites
Piejuras Hospital, Liepajas Oncological Clinic
Liepāja, LV-3401
Pauls Stradiņš Clinical University Hospital
Riga, LV - 1002
Riga Eastern University Hospital
Riga, LV-1079
Romania3 sites
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098
Institutul Oncologic Prof. Dr. Ion Chiricuţă
Cluj-Napoca, Cluj, 400015
SC Oncolab S.R.L.
Craiova, Dolj, 200385
Switzerland3 sites
Tumor Center Hirslanden Medical Center
Aarau, 5000
Spital STS AG Onkologiezentrum Thun - Berner Oberland
Thun, 3600
Kantonsspital Winterthur Medizinische Onkologie
Winterthur, 8401
Australia2 sites
The Queen Elizabeth Hospital
North Adelaide, South Australia, 5011
Royal Melbourne Hospital
Parkville, Victoria, 3050
Canada2 sites
Hopital Charles, LeMoyne Le Centre Intégré de Cancérologie de la Montérégie
Greenfield Park, Quebec, J4V 2H1
Centre Hospitalier Régional de Trois-Rivières
Trois-Rivières, Quebec, G8Z 3R9
Croatia2 sites
Clinical Hospital Osijek, Department of Radiotherapy and Oncology
Osijek, 31000
University Hospital For Tumors
Zagreb, 10000
Lithuania2 sites
Hospital of Lithuanian University of Health sciences
Kaunas, LT 45434
Nacionalinis Vezio Institutas, Vilniaus Universiteto Onkologijos Institutas
Vilnius, LT-08660
Serbia2 sites
Institute of Oncology and Radiology of Serbia
Belgrade, 11000
Clinical centre Nis Clinic of Oncology
Niš, 18000
Singapore2 sites
National University Hospital, National Cancer Institute
Singapore, 119082
National Cancer Centre Singapore
Singapore, 169610
United Kingdom2 sites
Guy's and St Thomas NHS Foundation Trust Management Offices 4th Floor Bermondsey Wing Guy's Hospital
London, SE1 9RT
Nottingham University Hospital
Nottingham, NG5 1PB
Germany1 site
Sozialstiftung Bamberg Klinik fuer Haematologie und internistische Onkologie
Bamberg, 96049
The Bahamas1 site
Affinity Research Limited
Nassau, CB, 13932
Turkey (Türkiye)1 site
Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi
Bornova, İzmir, 35040
About this study
Official title: 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
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.
- Conditions
- Breast Cancer
- Being tested
- Neratinib, Trastuzumab, Paclitaxel
- Keywords
- ErbB-2 positive advanced breast cancer, HKI-272, Neratinib, Nerlynx, HER2, PB-272, metastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeratinibDrug
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.
TrastuzumabDrug
Also called Herceptin, Herclon
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.
PaclitaxelDrug
Also called Taxol, Abraxane, Onxol, Nov-onxol
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.
| Study group | Role | What they receive |
|---|---|---|
| neratinib plus paclitaxel | Experimental | Not described Receives: Drug: Neratinib; Drug: Paclitaxel |
| trastuzumab plus paclitaxel | Active comparator | Not described Receives: Drug: Trastuzumab; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to disease progression or death, assessed up to 5.3 years
Secondary outcomes (4)
Objective Response Rate
Defined as the percentage of subjects who achieved confirmed tumor response (complete or partial response) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-Progressive Disease for non-target lesions, and no new lesions.
Measured: From randomization to disease progression or last tumor assessment, assessed up to 5.3 years
Duration of Response
Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, disease progression (PD), or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Measured: From first response to first PD or death, assessed up to 5.3 years after first subject randomized
Clinical Benefit Rate
Defined as the proportion of patients who achieved overall tumor response (CR or PR) or SD for at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: From randomization to disease progression or death, assessed up to 5.3 years
Symptomatic or Progressive Central Nervous System (CNS) Lesions
Defined as the time interval from the date of randomization until the first date of CNS symptoms, the imaging examination shows CNS progression or is censored at the last assessable evaluation on study or prior to new anti-cancer therapy, if applicable.
If median time to Symptomatic or Progressive CNS Lesions is not estimable, cumulative incidence will be reported instead.
Measured: From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study start21 Aug 2009
- Primary completionAug 2013
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puma Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Puma, Study director, Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915018
- Sponsor's protocol ID
- 3144A2-3005 / B1891005
- Acronym
- NEFERTT
- Status last verified
- Jul 2018
- First submitted
- 4 Jun 2009
- Last updated
- 22 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 27078022
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00915018
- Acronym / sponsor ID
- NEFERTT / 3144A2-3005 / B1891005
- Conditions
- Breast Cancer
- Keywords
- ErbB-2 positive advanced breast cancer, HKI-272, Neratinib, Nerlynx, HER2, PB-272, metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Puma Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2009 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 5 Jun 2009 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neratinib plus paclitaxel | Experimental | Drug: Neratinib, Drug: Paclitaxel |
| trastuzumab plus paclitaxel | Active comparator | Drug: Trastuzumab, Drug: Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeratinibNeratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent. | Drug | neratinib plus paclitaxel |
| TrastuzumabAlso: Herceptin, HerclonTrastuzumab - 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. | Drug | trastuzumab plus paclitaxel |
| PaclitaxelAlso: Taxol, Abraxane, Onxol, Nov-onxolPaclitaxel - 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. | Drug | neratinib plus paclitaxel, trastuzumab plus paclitaxel |
Primary outcome
Progression-Free Survival
Time frame: From randomization to disease progression or death, assessed up to 5.3 years
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.
4 secondary outcomes
Objective Response Rate
Time frame: From randomization to disease progression or last tumor assessment, assessed up to 5.3 years
Duration of Response
Time frame: From first response to first PD or death, assessed up to 5.3 years after first subject randomized
Clinical Benefit Rate
Time frame: From randomization to disease progression or death, assessed up to 5.3 years
Symptomatic or Progressive Central Nervous System (CNS) Lesions
Time frame: From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27078022Awada 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Puma study director
Biotechnology
195 sites in 35 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neratinib, Trastuzumab and Paclitaxel in people with Breast Cancer, run by Puma Biotechnology, Inc. at 195 sites in 35 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 195 sites in United States, Japan, Spain, France, India and 30 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: From randomization to disease progression or death, assessed up to 5.3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00915018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.