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

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

Status

Withdrawn

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00397761

Enrollment

Registered

2006-11-09

Start date

2006-07-31

Completion date

Unknown

Last updated

2021-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

inflammatory breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB 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.

Interventions

DRUGcapecitabine

DRUGpaclitaxel albumin-stabilized nanoparticle formulation

PROCEDUREneoadjuvant therapy

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 120 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate	—

Secondary

Measure	Time frame
Safety	—
Overall clinical response rate	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026