Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer (NEFERTT)

July 25, 2018 updated by: Puma Biotechnology, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

479

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • North Adelaide, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Bahamas
    • CB
      • Nassau, CB, Bahamas, 13932
        • Affinity Research Limited
  • Belarus
      • Gomel, Belarus, 246012
        • Institution Gomel Regional Clinical Oncology Dispensary
      • Grodno, Belarus, 230017
        • Institution of Healthcare Grodno Regional Clinical Hospital
      • Vitebsk, Belarus, 210603
        • Healthcare Institution Vitebsk Regional Clinical Oncology Dispensary
    • Minsk Region
      • Lesnoy, Minsk Region, Belarus, 223040
        • N.N. Aleksandrov National Cancer Center of Belarus
  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
  • Bulgaria
      • Plovdiv, Bulgaria, 4004
        • District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD
      • Sofia, Bulgaria, 1233
        • District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD
      • Sofia, Bulgaria, 1756
        • Specialised Hospital of ActiveTreatment in Oncology, Clinic of Chemotherapy
  • Canada
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Hopital Charles, LeMoyne Le Centre Intégré de Cancérologie de la Montérégie
      • Trois-Rivieres, Quebec, Canada, G8Z 3R9
        • Centre Hospitalier Regional de Trois-Rivieres
  • China
      • Beijing, China, 100021
        • Cancer hospital, Chinese Academy of Medical Sciences
      • Beijing, China, 100032
        • Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
      • Beijing, China, 100853
        • Chinese People's Liberation Army General Hospital
      • Beijing, China, 100071
        • The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Tian Jin, China, 300060
        • Tianjin Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun yat-sen University Cancer Center
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University Nanfang Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
  • Croatia
      • Osijek, Croatia, 31000
        • Clinical Hospital Osijek, Department of Radiotherapy and Oncology
      • Zagreb, Croatia, 10000
        • University Hospital For Tumors
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet, Copenhagen, Onkologisk Klinik
  • France
      • Creteil, France, 94010
        • Hôpital Henri-Mondor
      • Lyon, France, 69373
        • Centre Leon Berard Departement de Cancerologie Medicale
      • Montpellier, France, 34298
        • Centre Val d'Aurelle
      • Paris, France, 75651
        • Hôpital La Pitié-Salpétrière
      • Paris, France, 75181
        • Hopital Hotel Dieu, Service d'Oncologie Medicale, Bat B2, 5ieme
      • Paris, France, 75674
        • Groupe Hospitalier Paris Saint Joseph, Oncologie medicale
      • Perigueux, France, 24004
        • Service d'Oncologie et de Radiotherapie, Polyclinique Francheville
      • St. Brieuc, France, 22015
        • Clinique Armoricaine de Radiologie
      • Strasbourg, France, 67000
        • Centre de Radiothérapie, Clinique Sainte Anne, Service d'Oncologie Libérale
      • Strasbourg, France, 67091
        • CHU Strasbourg Departement Oncologie & Hematologie Hopital Civil
      • Tours, France, 37044
        • CHU Bretonneau, Centre Henry Kaplan
  • Germany
      • Bamberg, Germany, 96049
        • Sozialstiftung Bamberg Klinik fuer Haematologie und internistische Onkologie
  • Hong Kong
      • Chai Wan, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Wanchai, Hong Kong
        • UNIMED Medical Institute, Comprehensive Centre for Breast Diseases
  • Hungary
      • Budapest, Hungary, 1082
        • Semmelweis Egyetem Radiologiai és Onkoterapias Klinika
      • Budapest, Hungary, 1122
        • Országos Onkológiai Intézet "B" Belgyogyaszati osztaly
      • Budapest, Hungary, 1115
        • Fovarosi Onkormanyzat Szent Imre Korhaz Klinikai Onkologiai Profil
      • Kaposvar, Hungary, 7400
        • Kaposi Mor Oktato Korhoz Onkologiai Centrum
      • Kecskemet, Hungary, 6000
        • Bacs-Kiskun Megyei Onkormanyzat Korhaza Onkoradiologiai Kozpont
      • Miskolc, Hungary, 3526
        • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem Onkoterapias Klinika
  • India
    • Delhi
      • New Delhi, Delhi, India, 110029
        • Institute Rotary Cancer Hospital, AIIMS
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, India, 462001
        • Jawaharlal Nehru Cancer Hospital
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial Centre
      • Nagpur, Maharashtra, India, 440010
        • Central India Cancer Research Institute
      • Nashik, Maharashtra, India, 422004
        • Curie Manavata Cancer Centre
      • Nashilk, Maharashtra, India, 422005
        • Shatabdi Super Speciality Hospital
      • Pune, Maharashtra, India, 411001
        • Deenanath Mangeshkar Hospital and Research Centre
    • Rajasthan
      • Jaipur, Rajasthan, India, 302013
        • Searoc Cancer Center
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625107
        • Meenakshi Mission Hospital and Research Centre
    • West Bengal
      • Kolkata, West Bengal, India, 700053
        • B P Poddar and Medical Research Ltd.
  • Israel
      • Rehovot, Israel, 76101
        • Kaplan Medical Center
      • Tel Aviv, Israel, 64239
        • Sourasky Medical Center
      • Zerifin, Israel, 60930
        • Assaf Harofeh Medical Center
  • Italy
      • Modena, Italy, 41100
        • Policlinico di Modena Oncologia ed Ematologia
      • Pavia, Italy, 27100
        • Fondazione Salvatore Maugeri
      • Roma, Italy, 00128
        • Policlinico Universitario Campus Bio-Medico
      • Roma, Italy, 00189
        • Ospedale San Pietro Fatebenefratelli
      • Torino, Italy, 10126
        • Ospedale San Giovanni Battista-Molinette
  • Japan
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hospital
      • Hiroshima, Japan, 737-0023
        • National Hospital Organization Kure Medical Center and Chugoku Cancer Center
      • Hyogo, Japan, 650-0047
        • Kobe City Medical Center General Hospital
      • Hyogo, Japan, 651-0072
        • Shinko Hospital
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Osaka, Japan, 565-0871
        • Osaka University Hospital
      • Osaka, Japan, 530-8480
        • Tazuke Kofukai Medical Research Institute Kitano Hospital
      • Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital
      • Tokyo, Japan, 152-8902
        • National Hospital Organization Tokyo Medical Center
    • Akashi-shi
      • Hyogo, Akashi-shi, Japan, 673-8558
        • Hyogo Cancer Center
    • Beppu-shi
      • Oita, Beppu-shi, Japan, 874-0011
        • National Hospital Organization Beppu Medical Center
    • Bunkyo-ku
      • Tokyo, Bunkyo-ku, Japan, 113-8677
        • Tokyo Metropolitan Cancer and Infectious Disease Center, Komagome Hospital
    • Chiba-shi
      • Chiba, Chiba-shi, Japan, 260-8717
        • Chiba Cancer Center
    • Fukuoka-shi
      • Fukuoka, Fukuoka-shi, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
    • Higashiibaraki-gun
      • Ibaraki, Higashiibaraki-gun, Japan, 311-3193
        • National Hospital Organization Mito Medical Center
    • Hiroshima-shi
      • Hiroshima, Hiroshima-shi, Japan, 734-8551
        • Hiroshima University Hospital
    • Kagoshima-city
      • Kagoshima, Kagoshima-city, Japan, 892-0833
        • Hakuaikai Medical Corporation Sagara Hospital
    • Kashiwa-shi
      • Chiba, Kashiwa-shi, Japan, 277-8577
        • National Cancer Center Hospital East
    • Kitaadachi-gun
      • Saitama, Kitaadachi-gun, Japan, 362-0806
        • Saitama Cancer Center
    • Kumamoto-city
      • Kumamoto, Kumamoto-city, Japan, 862-8505
        • Kumamoto Municipal Hospital
    • Kurume-Shi
      • Fukuoka, Kurume-Shi, Japan, 830-0013
        • Kurume Daiichi Social Insurance Hospital
    • Matsuyama-city
      • Ehime, Matsuyama-city, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
    • Morioka-shi
      • Iwate, Morioka-shi, Japan, 020-8505
        • Iwate Medical University Hospital
    • Nagoya
      • Aichi, Nagoya, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center
    • Nagoya-shi
      • Aichi, Nagoya-shi, Japan, 464-8681
        • Aichi Cancer Center
    • Niigata-shi
      • Niigata, Niigata-shi, Japan, 951-8566
        • Niigata Cancer Center Hospital
    • Osaka-shi
      • Osaka, Osaka-shi, Japan, 537-8511
        • Osaka Medical Center for Cancer and Cardiovascular Diseases
      • Osaka, Osaka-shi, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital
    • Sapporo-shi
      • Hokkaido, Sapporo-shi, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
    • Sendai-city
      • Miyagi, Sendai-city, Japan, 980-8574
        • Tohoku University Hospital
    • Tenri-shi
      • Nara, Tenri-shi, Japan, 632-8552
        • Tenri Hospital
    • Yokohama-City
      • Kanagawa, Yokohama-City, Japan, 241-0815
        • Kanagawa cancer center
  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center, Center for Breast Cancer
    • Korea
      • Seoul, Korea, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Korea, Republic of, 152-703
        • Korea University Guro Hospital
    • Seoul/Korea
      • Seoul, Seoul/Korea, Korea, Republic of, 120-752
        • Yonsei University Health System Severance Hospital
  • Latvia
      • Liepaja, Latvia, LV-3401
        • Piejuras Hospital, Liepajas Oncological Clinic
      • Riga, Latvia, LV - 1002
        • Pauls Stradins Clinical University Hospital
      • Riga, Latvia, LV-1079
        • Riga Eastern University Hospital
  • Lithuania
      • Kaunas, Lithuania, LT 45434
        • Hospital of Lithuanian University of Health Sciences
      • Vilnius, Lithuania, LT-08660
        • Nacionalinis Vezio Institutas, Vilniaus Universiteto Onkologijos Institutas
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
  • Malta
      • Floriana, Malta, VLT 14
        • Sir Anthony Oncology Center
  • Poland
      • Bialystok, Poland, 15027
        • Białostockie Centrum Onkologii
    • Dolnoslaskie
      • Jelenia Gora, Dolnoslaskie, Poland, 58-506
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 04125
        • Magodent
    • Opolskie
      • Opole, Opolskie, Poland, 45061
        • Opolskie Centrum Onkologii
    • Warminsko-Mazurskie
      • Olsztyn, Warminsko-Mazurskie, Poland, 10228
        • Zakład Opieki Zdrowotnej MSW z Warmińsko, Mazurskim Centrum Onkologii
  • Portugal
      • Lisboa, Portugal, 1500-650
        • Hospital da Luz Servico de Oncologia Medica
  • Romania
      • Bucuresti, Romania, 050098
        • Spitalul Universitar de Urgență București
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Institutul Oncologic Prof. Dr. Ion Chiricuta
    • Dolj
      • Craiova, Dolj, Romania, 200385
        • SC Oncolab S.R.L.
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute of Oncology and Radiology of Serbia
      • Nis, Serbia, 18000
        • Clinical centre Nis Clinic of Oncology
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre Singapore
      • Singapore, Singapore, 119082
        • National University Hospital, National Cancer Institute
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6045
        • GVI Oncology
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2196
        • The Medical Oncology Centre of Rosebank
      • Johannesburg, Gauteng, South Africa, 2199
        • Sandton Oncology Centre
      • Johannesburg, Gauteng, South Africa, 2197
        • University of Witwatersrand Oncology, Donald Gordon Medical Centre
      • Pretoria, Gauteng, South Africa, 0081
        • Eastleigh Breast Care Centre
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa, 4001
        • Westridge Medical Centre
    • Western Cape
      • Kraaifontein, Western Cape, South Africa, 7570
        • GVI Oncology
  • Spain
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28033
        • Centro Oncológico MD Anderson
    • Cataluna
      • Lleida, Cataluna, Spain, 25198
        • Hospital Universitari Arnau de Vilanova
    • Galicia
      • Santiago de Compostela, Galicia, Spain, 15706
        • Complejo Hospitalario Universitario Santiago de Compostela
    • Illes Balears
      • Palma, Illes Balears, Spain, 07198
        • Hospital Son Llatzer
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Puerta de Hierro
      • Parla, Madrid, Spain, 28981
        • Hospital Universitario Infanta Cristina
      • Sanchinarro, Madrid, Spain, 28050
        • Hospital Madrid Norte Sanchinarro Centro Integral Oncológico Clara Campal Ensayos Clínicos
    • Malaga
      • Marbella, Malaga, Spain, 29603
        • Hospital Costa del Sol
    • Vizcaya
      • Baracaldo, Vizcaya, Spain, 48903
        • Hospital De Cruces
  • Switzerland
      • Aarau, Switzerland, 5000
        • Tumor Center Hirslanden Medical Center
      • Thun, Switzerland, 3600
        • Spital STS AG Onkologiezentrum Thun - Berner Oberland
      • Winterthur, Switzerland, 8401
        • Kantonsspital Winterthur Medizinische Onkologie
  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation, Linkou Branch
  • Turkey
    • Izmir
      • Bornova, Izmir, Turkey, 35040
        • Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi
  • Ukraine
      • Cherkassy, Ukraine, 18009
        • Komunalnyy Zaklad Cherkasskyy Oblasnyy Onkologichnyy Dyspanser
      • Chernivtsi, Ukraine, 58013
        • Chernivtsi Regional Oncology Centre Outpatient Department Bukovynian State Medical University Department of Oncology and Radiology
      • Dnipropetrovsk, Ukraine, 49102
        • City Multifield Clinical Hospital
      • Donetsk, Ukraine, 83092
        • Donetsk Regional Antitumor Center Department of Pretumor Diseases and Tumor Treatment
      • Kharkiv, Ukraine, 61024
        • S.P. Grigoreva Institute of Medical Radiology Department of Chemotherapy
      • Kyiv, Ukraine, 03022
        • National Institute of Cancer Department of Conseravtive Methods of Treatment
      • Lutsk, Ukraine, 63000
        • Volyn Regional Oncological Center
      • Lviv, Ukraine, 79031
        • State Oncological Regional Treatment and Diagnostic Center
      • Mariupil, Ukraine, 87500
        • Mariupil Oncological Center
      • Sumy, Ukraine, 40005
        • Sumy Regional Clinical Oncology Centre
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas NHS Foundation Trust Management Offices 4th Floor Bermondsey Wing Guy's Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospital
  • United States
    • California
      • Oxnard, California, United States, 93030
        • Ventura County Hematology-Oncology Specialists
      • Santa Rosa, California, United States, 95403
        • Redwood Regional Medical Group
    • Connecticut
      • Plainville, Connecticut, United States, 06062
        • Cancer Center of Central Connecticut
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Palm Beach Institute of Hematology and Oncology
      • Deerfield Beach, Florida, United States, 33064
        • North Broward Medical Center Cancer Center
      • Fort Lauderdale, Florida, United States, 33316
        • Broward General Medical Center
      • Orange City, Florida, United States, 32763
        • Mid Florida Cancer Centers
      • Plantation, Florida, United States, 33324
        • Florida Cancer Research Institute
      • Port Saint Lucie, Florida, United States, 34952
        • Hematology Oncology Associates of Treasure Coast
    • Georgia
      • Albany, Georgia, United States, 31701
        • Phoebe Cancer Center
      • Dublin, Georgia, United States, 31021
        • Dublin Hematology and Oncology Care
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Clintell
      • Skokie, Illinois, United States, 60077
        • Presence Hematology and Oncology
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • CHRISTUS St. Frances Cabrini Hospital
      • Metairie, Louisiana, United States, 70006
        • Hematology Oncology Services
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Park Nicollet Institute
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Missouri Cancer Associates
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine Siteman Cancer Center
      • Springfield, Missouri, United States, 65807
        • St. John's Medical Research Institute
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital, Luckow Pavilion Office of Oncology Clinical Trials
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
        • Gaston Hematology and Oncology Associates
    • Ohio
      • Akron, Ohio, United States, 44304-1619
        • Summa Health System Hospitals
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Warren Cancer Research Foundation
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Samaritan Hematology and Oncology Consultants
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Pawtucket Memorial Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina Hollings Cancer Center
      • Sumter, South Carolina, United States, 29150
        • Santee Hematology Oncology
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Tenessee Cancer Specialists
      • Memphis, Tennessee, United States, 38120
        • Family Cancer Care
    • Texas
      • Bedford, Texas, United States, 76022
        • Texas Oncology
      • El Paso, Texas, United States, 79902
        • El Paso Cancer Treatment Center
      • Midland, Texas, United States, 79701
        • Texas Oncology-Allison Cancer Center
      • Southlake, Texas, United States, 76092
        • Southlake Oncology
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center, Health, Education, and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: neratinib plus paclitaxel
Drug: Neratinib
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.
Drug: Paclitaxel
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.
Other Names:
  • Taxol
  • Abraxane
  • Onxol
  • Nov-onxol
Active Comparator: trastuzumab plus paclitaxel
Drug: Paclitaxel
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.
Other Names:
  • Taxol
  • Abraxane
  • Onxol
  • Nov-onxol
Drug: Trastuzumab
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.
Other Names:
  • Herceptin
  • Herclon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomization to disease progression or death, assessed up to 5.3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: From randomization to disease progression or last tumor assessment, assessed up to 5.3 years
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.
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
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.
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
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.
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

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.
From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puma Biotechnology, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

June 28, 2018

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 4, 2009

First Posted (Estimate)

June 5, 2009

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

July 25, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3144A2-3005 / B1891005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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