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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00600 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STU00045038 | Other Identifier | Northwestern University IRB# |
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| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
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This phase II trial studies how well giving eribulin mesylate and carboplatin together before surgery works in treating patients with stage I-III triple-negative breast cancer. Drugs used in chemotherapy, such as eribulin mesylate and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PRIMARY OBJECTIVES:
I. To determine the pathologic complete response rate (pCR) at the time of definitive surgery.
SECONDARY OBJECTIVES:
I. Determination of the clinical response rate, as measured by clinical exam and imaging studies prior to initiation of therapy and prior to surgery.
II. Measurement of alpha B-crystalline in tissue obtained before initiation of therapy and at the time of definitive surgery.
III. Stem cell markers (cluster of differentiation [CD]44+, CD24-, CD133, aldehyde dehydrogenase 1 [ALDH1] and evaluation of the NOTCH pathway) in tissue obtained before initiation of therapy and at the time of definitive surgery.
IV. Measurement of proliferation markers (Ki67) before and after treatment in tissue obtained before imitation of therapy and at the time of definitive surgery.
V. Measurement of beta III tubulin in tissue obtained before initiation of therapy and at the time of definitive surgery.
VI. Measurement of Tau in tissue obtained before initiation of therapy and at the time of definitive surgery.
VII. Safety evaluation, including following of patients for alopecia and neuropathy.
VIII. Epidermal growth factor receptor (EGFR) staining before and after treatment in tissue obtained before initiation of therapy and at the time of definitive surgery.
OUTLINE:
Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (neoadjuvant chemotherapy) | Experimental | Patients receive eribulin mesylate IV over 2-5 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eribulin mesylate | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the pathologic complete response rate (pCR). | Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of alpha B-crystalline in tissue obtained | Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy) | |
| Stem cell markers (CD44+, CD24-, CD133, ALDH1 and evaluation of the NOTCH pathway) in tissue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Kaklamani, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26006067 | Derived | Kaklamani VG, Jeruss JS, Hughes E, Siziopikou K, Timms KM, Gutin A, Abkevich V, Sangale Z, Solimeno C, Brown KL, Jones J, Hartman AR, Meservey C, Jovanovic B, Helenowski I, Khan SA, Bethke K, Hansen N, Uthe R, Giordano S, Rosen S, Hoskins K, Von Roenn J, Jain S, Parini V, Gradishar W. Phase II neoadjuvant clinical trial of carboplatin and eribulin in women with triple negative early-stage breast cancer (NCT01372579). Breast Cancer Res Treat. 2015 Jun;151(3):629-38. doi: 10.1007/s10549-015-3435-y. Epub 2015 May 26. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 21, 2023 | |
| Reset | Jan 18, 2024 |
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| carboplatin | Drug | Given IV |
|
|
| biopsy | Procedure | Correlative studies |
|
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| Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy) |
| Measurement of proliferation markers (Ki67) | Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy) |
| Measurement of beta III tubulin in tissue | Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy) |
| Measurement of Tau in tissue | Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy) |
| Determination of the clinical response rate, as measured by clinical exam and imaging studies prior to initiation of therapy and prior to surgery. | Imaging studies at baseline and at time of surgery (after approximately 12 weeks of neoadjuvant therapy) |
| Safety profile of this drug combination | Symptom assessment prior to each cycle (approximately every 3 weeks) and until resolution 6 months after the last dose of study treatment |
| EGFR staining before and after treatment | Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy) |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 21, 2023 | Jan 18, 2024 |
| ID | Term |
|---|---|
| D018567 | Breast Neoplasms, Male |
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C490954 | eribulin |
| D016190 | Carboplatin |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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