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A Study of Lapatinib in Combination With Everolimus in Patients With Advanced, Triple Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01272141
Recruitment Status : Terminated (Slow accrual, Funding stopped)
First Posted : January 7, 2011
Results First Posted : September 10, 2014
Last Update Posted : September 22, 2014
Sponsor:
Information provided by (Responsible Party):
William Read, Emory University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Neoplasms
Breast Cancer
Cancer of the Breast
Intervention Drug: Lapatinib and Everolimus
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A: Lapatinib Plus Everolimus
Hide Arm/Group Description

Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily

Everolimus: 5mg by mouth daily

Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Arm A: Lapatinib Plus Everolimus
Hide Arm/Group Description

Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily

Everolimus: 5mg by mouth daily

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants
41-45 years 2
46-50 years 2
51-55 years 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Overall Response Rate Will Measured Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Tumor Assessment for All Lesions Must be Performed Every Eight Weeks While on Study by CT Scan.
Hide Description [Not Specified]
Time Frame Tumor assessment for all lesions must be performed by CT scan every 8 weeks while on study.
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected due to early termination.
Arm/Group Title Arm A: Lapatinib Plus Everolimus
Hide Arm/Group Description:

Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily

Everolimus: 5mg by mouth daily

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title The Safety and Toxicity of the Combination Therapy of Lapatinib and Everolimus Will be Monitored Using the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 3.0. The Incidence of Any Grade 3 or 4 Toxicities Will be Analyzed.
Hide Description [Not Specified]
Time Frame Safety assessments will be performed every four weeks while the patient remains on study.
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected due to early termination.
Arm/Group Title Arm A: Lapatinib Plus Everolimus
Hide Arm/Group Description:

Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily

Everolimus: 5mg by mouth daily

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A: Lapatinib Plus Everolimus
Hide Arm/Group Description

Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily

Everolimus: 5mg by mouth daily

All-Cause Mortality
Arm A: Lapatinib Plus Everolimus
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Arm A: Lapatinib Plus Everolimus
Affected / at Risk (%)
Total   0/5 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A: Lapatinib Plus Everolimus
Affected / at Risk (%)
Total   1/5 (20.00%) 
Respiratory, thoracic and mediastinal disorders   
Shortness of breath due to pulmonary embolism  1/5 (20.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: William Read, MD
Organization: Emory University School of Medicine
Phone: 1-888-946-7447
EMail: william.l.read@emory.edu
Layout table for additonal information
Responsible Party: William Read, Emory University
ClinicalTrials.gov Identifier: NCT01272141    
Other Study ID Numbers: IRB00031112
WCI1711-09 ( Other Identifier: Other )
First Submitted: January 6, 2011
First Posted: January 7, 2011
Results First Submitted: September 3, 2014
Results First Posted: September 10, 2014
Last Update Posted: September 22, 2014