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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03525 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This trial will find the best dose of mifepristone when given together with nab-paclitaxel (Abraxane) based on the side effects of the two drugs in patients with advanced breast cancer.
Patients will be randomized to receive nab-paclitaxel with or without mifepristone during the first treatment cycle. After the first cycle, all patients will receive nab-paclitaxel with mifepristone until their disease worsens or they experience an unacceptable side effect.
This study will test up to 4 doses of mifepristone in combination with nab-paclitaxel. The study will first test the lowest dose in a small group of patients and if they do not have bad side effects, higher doses will be tested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (hormone therapy, chemotherapy) | Experimental | Patients will receive mifepristone and nab-paclitaxel in 28-day treatment cycles. Patients receive mifepristone once a day by mouth on days 0, 1, 7, 8, 14, and 15 and nab-paclitaxel by intravenous infusion (IV) on days 1, 8, and 15. Treatment cycles are repeated every 28 days in the absence of disease progression or unacceptable side effects. |
|
| Arm B (chemotherapy) | Active Comparator | Patients will receive nab-paclitaxel and placebo for a 28-day treatment cycle (Cycle 1). Patients receive placebo once a day by mouth on days 0, 1, 7, 8, 14, and 15 and nab-paclitaxel by intravenous infusion (IV) on days 1, 8, and 15. Patients then cross-over to Arm A after completion of the first treatment cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mifepristone | Drug | Given orally (by mouth) Up to 4 doses of mifepristone will be studied (300 mg, 600 mg, 900 mg, 1200 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the safest dose of mifepristone when given in combination with nab-paclitaxel | This study will seek the safest dose of mifepristone given in combination with nab-paclitaxel. Safety of each dose will be determined by the number and seriousness of side effects experienced by patients receiving each dose. | 28days (Cycle 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rita Nanda | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637-1470 | United States | ||
| NorthShore University Health System |
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| placebo | Drug | Given orally |
|
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| nab-paclitaxel | Drug | Given by intravenous infusion (IV) Dose of 80 mg/m2 |
|
|
| Evanston |
| Illinois |
| 60201 |
| United States |
| ID | Term |
|---|---|
| D018567 | Breast Neoplasms, Male |
| D001943 | 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 |
|---|---|
| D015735 | Mifepristone |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D013660 | Taxes |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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