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

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ClinicalTrials.gov Identifier: NCT00915018
Recruitment Status : Completed
First Posted : June 5, 2009
Results First Posted : November 6, 2017
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Tracking Information
First Submitted Date  ICMJE June 4, 2009
First Posted Date  ICMJE June 5, 2009
Results First Submitted Date  ICMJE August 10, 2017
Results First Posted Date  ICMJE November 6, 2017
Last Update Posted Date August 22, 2018
Actual Study Start Date  ICMJE August 21, 2009
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2009)
Progression-Free Survival [ Time Frame: 31 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2009)
Overall Survival [ Time Frame: 44 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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: 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
  • 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
Study Arms  ICMJE
  • Experimental: neratinib plus paclitaxel
    Interventions:
    • Drug: Neratinib
    • Drug: Paclitaxel
  • Active Comparator: trastuzumab plus paclitaxel
    Interventions:
    • Drug: Trastuzumab
    • Drug: Paclitaxel
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2017)
479
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2009)
1200
Actual Study Completion Date  ICMJE June 28, 2018
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bahamas,   Belarus,   Belgium,   Bulgaria,   Canada,   China,   Croatia,   Denmark,   France,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Malta,   Poland,   Portugal,   Romania,   Serbia,   Singapore,   South Africa,   Spain,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Argentina,   Brazil,   Colombia,   Greece,   Lebanon,   Mexico,   Peru,   Saudi Arabia
 
Administrative Information
NCT Number  ICMJE NCT00915018
Other Study ID Numbers  ICMJE 3144A2-3005 / B1891005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Puma Biotechnology, Inc.
Study Sponsor  ICMJE Puma Biotechnology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Puma Biotechnology
PRS Account Puma Biotechnology, Inc.
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP