- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00397761
Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer
Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
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.
Study Type
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Cancer Institute at Washington Hospital Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pathological complete response rate
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety
|
Overall clinical response rate
|
Collaborators and Investigators
Investigators
- Study Chair: Anita Aggarwal, DO, PhD, MedStar Health Research Institute
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Capecitabine
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- CDR0000513169
- WHC-MRI-GU-2006-097
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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