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| Name | Class |
|---|---|
| Ortho Biotech Products, L.P. | INDUSTRY |
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The study will evaluate the safety and efficacy of the combination PLD, paclitaxel, and trastuzumab in patients with operable breast cancer. Patients will be treated with the combination for 18 weeks, followed by surgery.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Liposomal Doxorubicin (Doxil) | Drug | Doxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab | within 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Identify the complete response rate | within 18 weeks | |
| Identify the partial response rate | within 18 weeks | |
| Identify the overall response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Macdonald, MD | CMO Aptium Oncology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence St. Joseph Medical Hospital | Burbank | California | 91505 | United States | ||
| Cedars-Sinai Outpatient Cancer Center |
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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 |
|---|---|
| C506643 | liposomal doxorubicin |
| D017239 | Paclitaxel |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| within 18 weeks |
| Evaluate changes in cardiac function | within study participation |
| Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen | within study participation |
| Los Angeles |
| California |
| 90048 |
| United States |
| Desert Regional Medical Center Comprehensive Cancer Center | Palm Springs | California | 92262 | United States |
| Lynn Regional Cancer Center West | Boca Raton | Florida | 33486 | United States |
| John H. Stroger, Jr. Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Maimonides Cancer Center | Brooklyn | New York | 11220 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| St Vincent Comprehensive Cancer Center | New York | New York | 10011 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45221 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |