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| ID | Type | Description | Link |
|---|---|---|---|
| WCI1711-09 | Other Identifier | Other |
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Slow accrual, Funding stopped
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The patient is being asked to join this clinical research study to find out if lapatinib, an agent that targets a protein, called epidermal growth factor receptor (EGFR) on the surface of cancer cells in combination with everolimus, an agent that targets a protein in the cancer cell, called mammalian target of rapamycin (mTOR) is effective in metastatic triple negative breast cancers that are no longer controlled by standard chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Lapatinib plus Everolimus | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lapatinib and Everolimus | Drug | Lapatinib: 1250 mg by mouth daily Everolimus: 5mg by mouth daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Tumor assessment for all lesions must be performed by CT scan every 8 weeks while on study. | |
| 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. | Safety assessments will be performed every four weeks while the patient remains on study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Read, MD | Emory University Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Emory Midtown (Crawford Long Hospital) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Lapatinib Plus Everolimus | Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily Everolimus: 5mg by mouth daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Lapatinib Plus Everolimus | Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily Everolimus: 5mg by mouth daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | No data were collected due to early termination. | Posted | Tumor assessment for all lesions must be performed by CT scan every 8 weeks while on study. |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: Lapatinib Plus Everolimus | Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily Everolimus: 5mg by mouth daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shortness of breath due to pulmonary embolism | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Read, MD | Emory University School of Medicine | 1-888-946-7447 | william.l.read@emory.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077341 | Lapatinib |
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Atlanta |
| Georgia |
| 30308 |
| United States |
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30329 | United States |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Primary | 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. | No data were collected due to early termination. | Posted | Safety assessments will be performed every four weeks while the patient remains on study. |
|
|
| 0 |
| 5 |
| 1 |
| 5 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |