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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
| Beth Israel Deaconess Medical Center | OTHER |
| Massachusetts General Hospital | OTHER |
The purpose of this trial is to see if Abraxane, which is a new form of paclitaxel, is safe as a replacement form of paclitaxel in dose-dense chemotherapy. This trial will also determine if using Abraxane will allow patients to receive treatment every two weeks without requiring injects of G-CSF, a white blood cell stimulating growth factor.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abraxane | Drug | Following 4 cycles (8 weeks) of adjuvant chemotherapy (adriamycin and cytoxan), abraxane will be give every 2 weeks for 4 cycles(8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the feasibility and toxicity of Abraxane after chemotherapy as part of dose-dense adjuvant chemotherapy for breast cancer. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the feasibility of administering Abraxane on a dose dense schedule without G-CSF support | 2 years | |
| to estimate the percentage of patients with various grades of hematologic toxicity, neurotoxicity, and other non-hematologic toxicity associated with dose-dense Abraxane |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harold Burstein, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massacusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
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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 |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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| 2 years |
| to evaluate quality of life. | 2 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |