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

Tracking Information

First Received Date ^ICMJE

November 8, 2006

Last Updated Date

February 6, 2009

Start Date ^ICMJE

July 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Pathological complete response rate [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Pathological complete response rate

Change History

Complete list of historical versions of study NCT00397761 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety [ Designated as safety issue: Yes ]
Overall clinical response rate [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Safety
Clinical overall response rate

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: capecitabine
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Procedure: neoadjuvant therapy

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00397761

Other Study ID Numbers ^ICMJE

CDR0000513169, WHC-MRI-GU-2006-097

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Washington Hospital Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Anita Aggarwal, DO, PhD

Washington Hospital Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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