Lapatinib in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00477464

First received: May 22, 2007

Last updated: September 15, 2011

Last verified: September 2011

History of Changes

Results First Received: August 4, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Metastatic Breast Cancer Neoplasms, Breast
Interventions:	Drug: Lapatinib Drug: capecitabine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2	Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.

Participant Flow: Overall Study

	Lapatinib 1250 mg and Capecitabine 2000 mg/m^2
STARTED	51
COMPLETED	0
NOT COMPLETED	51
Lost to Follow-up	1
Death	36
Completion of protocol-defined follow-up	14

Baseline Characteristics

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Reporting Groups

	Description
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2	Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.

Baseline Measures

	Lapatinib 1250 mg and Capecitabine 2000 mg/m^2
Number of Participants [units: participants]	51
Age [units: Years] Mean ± Standard Deviation	55.5 ± 8.85
Gender [units: Participants]
Female	51
Male	0
Race/Ethnicity, Customized [units: participants]	51

Outcome Measures

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1. Primary:

Clinical Benefit Response (Independent Reviewer-assessed) [ Time Frame: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression (up to Week 119) ]

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2. Secondary:

Time to Progression (Independent Reviewer-assessed) [ Time Frame: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death due to breast cancer (up to Week 119) ]

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3. Secondary:

Progression-free Survival (PFS) (Independent Reviewer-assessed) [ Time Frame: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119) ]

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4. Secondary:

6-Month Progression-free Survival (Independent Reviewer-assessed) [ Time Frame: Baseline and then every 6 weeks until Month 6 (Week 24) ]

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5. Secondary:

Objective Response (Independent Reviewer-assessed) [ Time Frame: Baseline every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119) ]

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6. Secondary:

Overall Survival (Independent Reviewer-assessed) [ Time Frame: Baseline and then followed every 4 weeks until death (up to Week 157.9) while on treatment. After treatment termination, followed every 12 weeks until death (up to Week 157.9) ]

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7. Secondary:

Time to Response (Independent Reviewer-assessed) [ Time Frame: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119) ]

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8. Secondary:

Duration of Response (Independent Reviewer-assessed) [ Time Frame: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119) ]

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9. Secondary:

Maximum Plasma Concentration (Cmax) of Lapatinib [ Time Frame: Week 2 ]

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10. Secondary:

Time to Maximum Plasma Concentration (Tmax) of Lapatinib [ Time Frame: Week 2 ]

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11. Secondary:

Terminal Elimination Half-life (t1/2) of Lapatinib [ Time Frame: Week 2 ]

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12. Secondary:

Area Under the Plasma Concentration-time Curve Within the Dosing Interval AUC0-tau of Lapatinib [ Time Frame: Week 2 ]

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13. Secondary:

Area Under the Plasma Concentration-time Curve From Zero to 24 Hours AUC0-24 of Lapatinib [ Time Frame: Week 2 ]

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14. Secondary:

Cmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL) [ Time Frame: Week 2 ]

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15. Secondary:

Tmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL) [ Time Frame: Week 2 ]

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16. Secondary:

t1/2 of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL) [ Time Frame: Week 2 ]

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17. Secondary:

AUC0-tau of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL) [ Time Frame: Week 2 ]

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18. Secondary:

Area Under the Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12) of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL) [ Time Frame: Week 2 ]

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19. Secondary:

Trough Concentration of Lapatinib [ Time Frame: Week 2 ]

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20. Secondary:

Trough Concentration of Capecitabine, 5-FU, and FBAL [ Time Frame: Week 2 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00477464 History of Changes
Other Study ID Numbers:	109749
Study First Received:	May 22, 2007
Results First Received:	August 4, 2011
Last Updated:	September 15, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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