Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00915018

Purpose

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	Intervention	Phase
Breast Cancer Advanced Breast Cancer	Drug: Neratinib + Paclitaxel Drug: Trastuzumab + Paclitaxel	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Trastuzumab

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Progression-Free Survival [ Time Frame: 31 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	480
Study Start Date:	August 2009
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Neratinib + Paclitaxel	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.
Active Comparator: 2 Trastuzumab + Paclitaxel	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915018

Show 194 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00915018 History of Changes
Other Study ID Numbers:	3144A2-3005, B1891005
Study First Received:	June 4, 2009
Last Updated:	February 5, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Trastuzumab
Tubulin Modulators

Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012