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Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer

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ClinicalTrials.gov Identifier: NCT00397761
Recruitment Status : Unknown
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : November 9, 2006
Last Update Posted : February 9, 2009
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: capecitabine Drug: paclitaxel albumin-stabilized nanoparticle formulation Procedure: neoadjuvant therapy Phase 2 Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer
Study Start Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. Pathological complete response rate

Secondary Outcome Measures :
  1. Safety
  2. Overall clinical response rate


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397761


Locations
United States, District of Columbia
Washington Cancer Institute at Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Clinical Trials Office - Washington Cancer Institute    202-877-8839      
Sponsors and Collaborators
Washington Hospital Center
Investigators
Study Chair: Anita Aggarwal, DO, PhD Washington Hospital Center

ClinicalTrials.gov Identifier: NCT00397761     History of Changes
Other Study ID Numbers: CDR0000513169
WHC-MRI-GU-2006-097
First Posted: November 9, 2006    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: November 2006

Keywords provided by National Cancer Institute (NCI):
inflammatory breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Capecitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites