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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medstar Health Research Institute; Washington Hospital Center
• Treatments: Albumin-Bound Paclitaxel; Capecitabine; Paclitaxel

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