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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Neratinib Drug: Trastuzumab Drug: Paclitaxel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 479 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 21, 2009
Actual Primary Completion Date : August 2013
Actual Study Completion Date : June 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915018


Locations
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Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
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Study Director: Puma Biotechnology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00915018    
Other Study ID Numbers: 3144A2-3005 / B1891005
First Posted: June 5, 2009    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: August 22, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Puma Biotechnology, Inc.:
ErbB-2 positive advanced breast cancer
HKI-272
Neratinib
Nerlynx
 HER2
PB-272
metastatic breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Trastuzumab
Albumin-Bound Paclitaxel
Neratinib
Antineoplastic Agents, Phytogenic
 Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors