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

Sponsored by:	Washington Hospital Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00397761

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 II Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer

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

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

Study ID Numbers:	CDR0000513169, WHC-MRI-GU-2006-097
Study First Received:	November 8, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00397761
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

Study placed in the following topic categories:

Capecitabine
Inflammatory breast cancer
Skin Diseases

Paclitaxel
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009