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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00397761
• Other study ID #: CDR0000513169
• Secondary ID: WHC-MRI-GU-2006-
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: July 2006

Study information

• Verified date: February 2021
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• capecitabine

• paclitaxel albumin-stabilized nanoparticle formulation

Procedure:
• neoadjuvant therapy

Locations

Country	Name	City	State
United States	Washington Cancer Institute at Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response rate
Secondary	Safety
Secondary	Overall clinical response rate