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Clinical Trial Results:
A Phase 2 Randomized Open Label Study of Neratinib versus Lapatinib plus Capecitabine for the Treatment of ErbB-2 Positive Locally Advanced or Metastatic Breast Cancer

Summary
EudraCT number	2008-005425-11
Trial protocol	HU SI BE DE ES CZ IT GR FR AT GB BG NL
Global end of trial date	20 Jun 2018

Results information
Results version number	v2(current)
This version publication date	06 Jul 2019
First version publication date	25 Dec 2016
Other versions	v1
Version creation reason	New data added to full data set Update to reflect final study close out.
Summary report(s)	3144A2-3003 PDS

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

3144A2-3003-WW

ISRCTN number

US NCT number

NCT00777101

WHO universal trial number (UTN)

Sponsor organisation name

Puma Biotechnology, Inc.

Sponsor organisation address

10880 Wilshire Blvd, Suite 2150, Los Angeles, United States, 90024

Public contact

Sr. Director, Clinical Operations, Puma Biotechnology, Inc., 1 4242486500, clinicaltrials@pumabiotechnology.com

Scientific contact

Sr. Director, Clinical Operations, Puma Biotechnology, Inc., 1 4242486500, clinicaltrials@pumabiotechnology.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

20 Jun 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

20 Jun 2018

Was the trial ended prematurely?

Main objective of the trial

Compare the investigator assessed progression-free survival (PFS) following treatment with single agent neratinib versus lapatinib plus capecitabine in subjects with erbB2 positive locally advanced or metastatic breast cancer.

Protection of trial subjects

This study was designed and monitored in accordance with Sponsor procedures, which comply with the ethical principles of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP), including the Declaration of Helsinki and the applicable laws and regulations. The protocol, the investigator’s brochure (IB), and the informed consent form (ICF) for this clinical study were submitted to an institutional review board (IRB) or an independent ethics committee (IEC) for review and written approval. Any subsequent amendments to the protocol or any revisions to the ICF were submitted for IRB or IEC review and written approval. This study was conducted in accordance with the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) and the ethical principles that have their origins in the Declaration of Helsinki. All investigators have provided written commitments to comply with GCP standards and the protocol. Clinical trial data were monitored at regular intervals by the Sponsor or their representative throughout the study to verify compliance to study protocol, completeness, accuracy and consistency of the data and adherence to local regulations on the conduct of clinical research. Participants were discontinued from active treatment if any of the following occurred: documented disease progression, adverse event (AE), symptomatic deterioration, subject request, investigator request, protocol violation, discontinuation of the study by the sponsor, lost to follow up, or death.

Background therapy

Evidence for comparator

Actual start date of recruitment

04 Feb 2009

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country