Trials Sponsors Conditions Drugs Pricing

Conditions

Neoplasms, Breast

Keywords

metastatic breast cancerErbB1kinase inhibitorErbB2EGFRlapatinibHer2-neu

Outcome Measures

Primary Outcomes (2)

Time to Progression as Evaluated by the Investigator
Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The investigator assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors \[RECIST\] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the investigator, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.
Randomization until the date of disease progression or death (average of 26 weeks)
Time to Progression as Evaluated by the Independent Review Committee (IRC)
Time to progression is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The IRC assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors \[RECIST\] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the independent reviewer, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.

Secondary Outcomes (18)

Number of Participants With Tumor Response as Evaluated by the Investigator
Randomization until the date of disease progression or death (average of 26 weeks)
Number of Participants With Tumor Response as Evaluated by the Independent Review Committee
Randomization until the date of disease progression or death (average of 26 weeks)
Percentage of Participants With Clinical Benefit (CB) as Assessed by the Investigator
Randomization until the date of disease progression or death (average of 26 weeks)
Number of Participants With a Response of CR or PR by the Indicated Study Week
Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72
Duration of Response (DOR)
From the time of the first documented complete or partial response until the first documented evidence of progression or death (average of 26 weeks)
+13 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL

Lapatinib 1500 mg, once daily and Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks

Drug: PaclitaxelDrug: GW572016 (Lapatinib)

Arm 2

PLACEBO COMPARATOR

Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks and Placebo

Drug: Paclitaxel

Interventions

PaclitaxelDrug

Active Comparator

Arm 1Arm 2

GW572016 (Lapatinib)Drug

Oral GW572016 Lapatinib

Also known as: Paclitaxel

Arm 1

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed Informed Consent
Able to swallow an oral medication

Sponsors & Collaborators

GlaxoSmithKline
Industrylead

Study Sites (177)

GSK Investigational Site

Tucson, Arizona, 85712, United States

GSK Investigational Site

Hot Springs, Arkansas, 71913, United States

GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

GSK Investigational Site

Fountain Valley, California, 92708, United States

GSK Investigational Site

La Jolla, California, 92093-0987, United States

GSK Investigational Site

Rancho Mirage, California, 92270, United States

GSK Investigational Site

Vallejo, California, 94589, United States

Related Publications (3)

Tenori L, Oakman C, Claudino WM, Bernini P, Cappadona S, Nepi S, Biganzoli L, Arbushites MC, Luchinat C, Bertini I, Di Leo A. Exploration of serum metabolomic profiles and outcomes in women with metastatic breast cancer: a pilot study. Mol Oncol. 2012 Aug;6(4):437-44. doi: 10.1016/j.molonc.2012.05.003. Epub 2012 Jun 1.
PMID: 22687601BACKGROUND
Finn RS, Press MF, Dering J, Arbushites M, Koehler M, Oliva C, Williams LS, Di Leo A. Estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2 (HER2), and epidermal growth factor receptor expression and benefit from lapatinib in a randomized trial of paclitaxel with lapatinib or placebo as first-line treatment in HER2-negative or unknown metastatic breast cancer. J Clin Oncol. 2009 Aug 20;27(24):3908-15. doi: 10.1200/JCO.2008.18.1925. Epub 2009 Jul 20.
PMID: 19620495BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

PaclitaxelLapatinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, Cyclic

Results Point of Contact

Title: GSK Response Center
Organization: GlaxoSmithKline

Study Officials

GSK Clinical Trials
GlaxoSmithKline
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

580 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 7, 2004

First Posted

January 9, 2004

Study Start

January 2004

Date type not reported

This date has not been verified as actual or estimated.

Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (18)

Study Arms (2)

Arm 1

Arm 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (177)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (18)

Study Arms (2)

Arm 1

Arm 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (177)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations