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

Sponsor

Medstar Health Research Institute (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00397761

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: capecitabine Drug: paclitaxel albumin-stabilized nanoparticle formulation Procedure: neoadjuvant therapy	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Masking:

None (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

Study Start Date :

Jul 1, 2006

Outcome Measures

Primary Outcome Measures

Pathological complete response rate []

Secondary Outcome Measures

Safety []
Overall clinical response rate []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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