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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
| Celgene Corporation | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to determine how well this combination of chemotherapy drugs works with bevacizumab in eliminating primary tumor in the breast prior to surgery(pathological complete response or pCR in the breast). Bevacizumab is a drug that works by blocking new blood vessel formation by the tumor cells. Giving chemotherapy and bevacizumab before surgery may allow for lesser amount of breast tissue to be removed. To be able to predict in the future which patients are more likely to get pCR to this drug combination, specialized tests on tumor tissue will be performed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab, nab-paclitaxel, carboplatin, doxorubicin hydrochloride, cyclophosphamide, PEG-Filgrastim | Drug | Eligible patients will receive:
After completion of the above regimen, patients will receive:
Patients will then proceed with: - Surgery including axillary staging A minimum of 4 weeks post operatively, patient will receive: - Bevacizumab IV on days 1 and 15. Treatment will be repeated every 28 days for 8 courses. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) in the breast | No interim efficacy analysis is planned. It is anticipated that the definitive analysis would be performed approximately 3 years after initiation of accrual (2 years to accrue 60 patients plus one additional year of follow up) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of near pCR/pCR of breast, axillary Ns & non axillary SNs cRR with nab-paclitaxel + carbo with bev cRR post neoadj Tx Rate of breast conserving surgery Safety & tolerability Disease free survival Identify gene(s) that may predict pCR to Tx | Approximately 3 years from study initiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jasgit C. Sachdev, MD | University of Tennessee Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Cancer Institute | Memphis | Tennessee | 38104 | United States | ||
| The West Clinic |
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| Memphis |
| Tennessee |
| 38120 |
| United States |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| ID | Term |
|---|---|
| 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 |
|---|---|
| D000068258 | Bevacizumab |
| C520255 | 130-nm albumin-bound paclitaxel |
| D016190 | Carboplatin |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| C455861 | pegfilgrastim |
| ID | Term |
|---|---|
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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