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Phase II/III Study of Neoadjuvant Therapy Comprising Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) (Abraxane®) in Women With Previously Untreated, Unresected, Stage II-IIIB Breast Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer
Basic Trial Information
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Protocol IDs
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Phase III, Phase II
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Treatment
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Active
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18 and over
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WHC-MRI-GU-2006-097
NCT00397761
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Objectives Primary - Determine the rate of pathological complete response (i.e., tumor completely gone) in women with previously untreated, unresected, stage II-IIIB breast cancer treated with neoadjuvant therapy comprising capecitabine and paclitaxel (albumin-stabilized nanoparticle formulation) (Abraxane®).
Secondary - Evaluate the safety of this regimen in these patients.
- Determine overall clinical response rate in patients treated with this regimen.
Entry Criteria Disease Characteristics:
- Histologically confirmed infiltrating carcinoma of the breast or inflammatory breast cancer
- Stage II-IIIB disease (T1-4, N1-2, M0)
- 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:
- Any estrogen/progesterone status (positive, negative, or unknown) allowed
Prior/Concurrent Therapy:
- See Disease Characteristics
Patient Characteristics:
- Female
- Menopausal status not specified
- ECOG performance status 0-2
- Life expectancy > 3 months
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- Hemoglobin > 9.0 g/dL
- Creatinine < 1.5 mg/dL
- Bilirubin < 1.5 times upper limit of normal (ULN)
- ALT and AST < 2.5 times ULN (5 times ULN if due to Gilbert's disease)
- Alkaline phosphatase < 2.5 times ULN (5 times ULN if due to Gilbert's disease)
Expected Enrollment 33A total of 33 patients will be accrued for this study. Outcomes Primary Outcome(s)Pathological complete response rate
Secondary Outcome(s)Safety
Overall clinical response rate
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.
Trial Contact Information
Trial Lead Organizations Washington Cancer Institute at Washington Hospital Center | | | | Anita Aggarwal, DO, PhD, Protocol chair | | | |
Trial Sites
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| District of Columbia |
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Washington |
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| | | | | | | | | Washington Cancer Institute at Washington Hospital Center |
| | | Clinical Trials Office - Washington Cancer Institute | |
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| Registry Information | | | Official Title | | Combination Capecitabine (Xeloda®) and ABI-007 (Abraxane®, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer | | | Trial Start Date | | 2006-07-27 | | | Registered in ClinicalTrials.gov | | NCT00397761 | | | Date Submitted to PDQ | | 2006-10-12 | | | Information Last Verified | | 2006-11-14 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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