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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00397761
First received: November 8, 2006
Last updated: February 6, 2009
Last verified: November 2006
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Drug: capecitabine
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Procedure: neoadjuvant therapy
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pathological complete response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Overall clinical response rate [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00397761     History of Changes
Other Study ID Numbers: CDR0000513169, WHC-MRI-GU-2006-097
Study First Received: November 8, 2006
Last Updated: February 6, 2009
Health Authority: Unspecified

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
Capecitabine
Fluorouracil
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013