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| ID | Type | Description | Link |
|---|---|---|---|
| WHC-MRI-GU-2006-097 |
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RATIONALE: Drugs used in chemotherapy, such as capecitabine and paclitaxel (albumin-stablized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II/III trial is studying how well giving capecitabine together with paclitaxel (albumin-stabilized nanoparticle formulation) works in treating women undergoing surgery for stage II or stage III breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive up to 4 courses of capecitabine and paclitaxel (nanoparticle albumin-stabilized formulation) (Abraxane^®) in the absence of disease progression. Patients then undergo definitive surgical resection of the tumor off study.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine | Drug | |||
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | |||
| neoadjuvant therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response rate |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | ||
| Overall clinical response rate |
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DISEASE CHARACTERISTICS:
Histologically confirmed infiltrating carcinoma of the breast or inflammatory breast cancer
Previously untreated disease
Previously unresected disease
High-risk disease that is not resectable by lumpectomy alone
Any HER2/neu status (positive, negative, or unknown) allowed
Hormone receptor status:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Anita Aggarwal, DO, PhD | Medstar Health Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Cancer Institute at Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D058922 | Inflammatory 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 |
|---|---|
| D000069287 | Capecitabine |
| D013660 | Taxes |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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