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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00915018
First received: June 4, 2009
Last updated: May 7, 2012
Last verified: May 2012
History of Changes

June 4, 2009
May 7, 2012
August 2009
May 2013   (final data collection date for primary outcome measure)
Progression-Free Survival [ Time Frame: 31 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00915018 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: 43 months ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: 31 months ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: 31 months ] [ Designated as safety issue: No ]
  • Clinical Benefit Rate [ Time Frame: 31 months ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events between treatment arms [ Time Frame: 31 months ] [ Designated as safety issue: Yes ]
  • Patient Reported Breast Specific Quality of Life [ Time Frame: 31 months ] [ Designated as safety issue: No ]
  • Frequency of symptomatic or progressive CNS lesions [ Time Frame: 31 months ] [ Designated as safety issue: No ]
  • Time to symptomatic or progressive CNS lesions [ Time Frame: 31 months ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: 44 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Advanced Breast Cancer
  • Drug: Neratinib + Paclitaxel

    Neratinib - 240 mg orally daily, administered once daily Paclitaxel - 80mg/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: Trastuzumab + Paclitaxel

    Trastuzumab - 4mg/kg IV initial loading dose followed by subsequent once weekly doses of 2mg/kg IV.

    Paclitaxel - 80mg/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.
  • Experimental: 1
    Neratinib + Paclitaxel
    Intervention: Drug: Neratinib + Paclitaxel
  • Active Comparator: 2
    Trastuzumab + Paclitaxel
    Intervention: Drug: Trastuzumab + Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
480
July 2013
May 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   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
 
NCT00915018
3144A2-3005, B1891005
Yes
Puma Biotechnology, Inc.
Puma Biotechnology, Inc.
Not Provided
Study Director: Puma Biotechnology
Puma Biotechnology, Inc.
May 2012

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