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Sponsor withdrew support
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The investigators want to find out if the treatments used in this study are helpful to patients that are diagnosed with hormone receptor positive metastatic breast cancer. The investigators want to also look at any side effects that could happen while patients are on the study treatments. The investigators want to see if there are any changes that could show us if your cancer is responding to the study treatments.
The study design is a phase II design. Eligible patients will undergo staging work up and start treatment. Every 28-day period (4 weeks) will count as a cycle. Medical evaluations will be performed every 4 weeks and staging work up will be repeated every 12 weeks.
The primary objective of the study is to assess progression free survival (PFS) of treatment with exemestane and sunitinib in post¬menopausal subjects with hormone receptor positive (ER-positive and/or PR-positive) unresectable locally advanced or metastatic breast cancer subjects who have progressed on prior hormonal treatment.
In addition we want to:
1. Blood samples will be drawn for enumeration and profiling of circulating tumor cells and circulating endothelial cells at study entry (prior to starting study medications), four weeks after starting study medications, twelve weeks after starting study medications and at disease progression. These samples will be strongly encouraged but the patients may decline any or all of them without impacting their eligibility or continuation on the study.
2. If the patient participating on the study has an easily accessible breast mass or metastatic lesion (e.g. lymphadenopathy, skin metastasis, chest wall metastasis), a core needle or punch biopsy will be obtained at study entry (prior to starting study medications), four weeks after starting study medications, and at disease progression. These biopsies will be strongly encouraged but the patients may decline any or all of them without impacting their eligibility or continuation on the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exemestane plus Sutent | Experimental | All patients enrolled on the study will receive treatment as follows:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exemestane | Drug | Exemestane 25 mg by mouth every day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression in Weeks | Time from the first day of treatment to date of progression in weeks | Medical evaluation every 4 weeks;The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance |
| Measure | Description | Time Frame |
|---|---|---|
| Obtain Assessments of Overall Response Rate, Clinical Benefit Rate, and Overall Survival | 5 years | |
| Determine the Safety and Tolerability | 5 years | |
| Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mothaffar Rimiawi, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine, Lester and Sue Smith Breast Center | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exemestane Plus Sutent | All patients enrolled on the study will receive treatment as follows:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exemestane Plus Sutent | All patients enrolled on the study will receive treatment as follows:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Time to Disease Progression in Weeks | Time from the first day of treatment to date of progression in weeks | 2 patients developed disease progression. | Posted | Mean | Full Range | week | Medical evaluation every 4 weeks;The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance |
|
|
Medical evaluation every 4 weeks. The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance.
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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 | Exemestane Plus Sutent | All patients enrolled on the study will receive treatment as follows:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mothaffar Rimawi | Baylor College of Medicine | 713-798-1311 | rimawi@bcm.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C056516 | exemestane |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sutent | Drug | Sunitinib 37.5 mg by mouth every day. |
|
|
| 5 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Obtain Assessments of Overall Response Rate, Clinical Benefit Rate, and Overall Survival | The study was terminated early before target accrual. 4 patients were enrolled and received treatment. 2 patients developed progression and 2 patients was drop-off the study due to adverse events. | Posted | Number | paticipants | 5 years |
|
|
|
| Secondary | Determine the Safety and Tolerability | The study was terminated early before target accrual. 4 patients were enrolled and received treatment. 2 patients developed progression and 2 patients was drop-off the study due to adverse events. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells | The study was terminated early before target accrual. 4 patients were enrolled and received treatment. 2 patients developed progression and 2 patients was drop-off the study due to adverse events. | Posted | Median | 95% Confidence Interval | cell | 5 years |
|
|
|
| 1 |
| 4 |
| 4 |
| 4 |
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Systematic Assessment |
|
| Alkaline phosphatase | Metabolism and nutrition disorders | Systematic Assessment |
|
| Dermatology/Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
|
| Mucositis/stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Ocular/Visual | Eye disorders | Systematic Assessment |
|
| pain | General disorders | Systematic Assessment |
|
| platelets | Blood and lymphatic system disorders | Systematic Assessment |
|
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Thrombosis/embolism | Vascular disorders | Systematic Assessment |
|
| Thyroid function, low | Endocrine disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |