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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001938-35 | EudraCT Number | ||
| AGO-B-049 | Other Identifier | AGO-B-ID |
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| Name | Class |
|---|---|
| Eisai GmbH | INDUSTRY |
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After progression of disease after one chemotherapy, metastatic breast cancer patients will be randomized 1:1 to one of the following treatment arms:
Arm A. Eribulin Arm B. Paclitaxel
Blood draws for immune analysis will be performed before start of therapy, on day 1 of cycle 2 and on day 21 of cycle 4 (end of therapy) for the primary study aim. Patients will be treated under study conditions for a maximum of 4 therapy cycles.
This is a prospective, randomized Phase IV study. Patients who progressed after one chemotherapy in the metastatic setting will be randomized 1:1 to one of the following treatment arms. Arm A. Eribulin 1.23 mg/m2 on days 1 and 8 q21d Arm B. Paclitaxel 80 mg/m2 on days 1, 8, and 15 q21d Blood draws for immune analysis will be performed before start of therapy on day 1 of cycle 1, on day 1 of cycle 2 (pre dose each) and on day 21 of cycle 4 (end of therapy) and assessed for the primary study aim. Patients will be treated under study conditions for a maximum of 4 therapy cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eribulin | Experimental | Arm A. Eribulin 1.23 mg/m^2, administered as an injection on day 1 and 8 q 21d for a maximum of 4 therapy cycles |
|
| Paclitaxel | Active Comparator | Paclitaxel 80 mg/m^2, administered as an injection on day 1, 8 and 15 q21d for a maximum of 4 therapy cycles |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eribulin Injection [Halaven] | Drug | on days 1 and 8 q21d |
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| Measure | Description | Time Frame |
|---|---|---|
| Immune responsivity (IR) | defined as ≥ 5% of all T cells from peripheral blood are Ki-67 positive after chemotherapy | 12 weeks after therapy start |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response after three months | Overall response | three months after therapy start |
| Progression free survival | Progression free survival |
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Inclusion Criteria:
Creatinine Clearance > 50 ml/min ANC ≥ 1.5 x 10 3 /μL Thrombocytes > 100 x 10 3 /μL
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AIRE Study manager | Contact | +49 (0) 9131 927 9578 | aire@ifg-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Peter A Fasching, MD, Prof. | Department of Gynecology and Obstetrics, Erlangen University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecology, Tübingen University Hospital | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C490954 | eribulin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel injection | Drug | on days 1, 8, and 15 q21d |
|
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| From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Overall survival | Overall survival | From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months |
| Toxicity and safety of eribulin and paclitaxel | Toxicity and safety of eribulin and paclitaxel | Therapy start until 30 days post last dose |
| EORTC QLQC30 | Quality of life assessed via EORTC QLQC30 | Therapy start until therapy end after 4 cycles up to 12 weeks |
| Department of Gynecology and Obstetrics, Erlangen University Hospital | Recruiting | Erlangen | Bavaria | 91054 | Germany |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |