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

MedStar Health

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Drug: paclitaxel albumin-stabilized nanoparticle formulation; Procedure: neoadjuvant therapy; Drug: capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00397761

WHC-MRI-GU-2006-097

CDR0000513169

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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