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

NCT ID: NCT00397761

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31

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.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

capecitabine

Intervention Type: DRUG

paclitaxel albumin-stabilized nanoparticle formulation

Intervention Type: DRUG

neoadjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Principal Investigators

Anita Aggarwal, DO, PhD

Role: STUDY_CHAIR

Medstar Health Research Institute

Locations

Washington Cancer Institute at Washington Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

WHC-MRI-GU-2006-097

Identifier Type: -

Identifier Source: secondary_id

CDR0000513169

Identifier Type: -

Identifier Source: org_study_id