Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.

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

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Trastuzumab

Criteria

Inclusion Criteria:

• Confirmed adenocarcinoma of the breast

• Tumor shows 3+ overexpression of the human epidermal growth factor receptor 2 (HER-2)/proto-oncogene by immunohistochemistry assay, or is fluorescence in situ hybridization (FISH)+

• Stage IV disease

• Measurable disease

• At least 3 weeks since prior cytotoxic chemotherapy

• At least 4 weeks since radiotherapy with full recovery

• At least 4 weeks since major surgery with full recovery

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• At least 18 years old

• Absolute neutrophil count (ANC) at least 1.5 x 10^9 cells/L

• Platelets at least 100 x 10^9 cells/L

• Hemoglobin at least 9 g/dL

• Aspartame aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5X upper limit normal

• Alkaline Phosphatase less than 1.5X upper limit normal

• Creatinine less than 1.5 gm/dL

• Normal left ventricular ejection fraction

• Negative pregnancy test

• Agree to use method to avoid pregnancy

• Informed Consent is obtained

Exclusion Criteria:

• Up to one regimen of prior neo-adjuvant or adjuvant chemotherapy is allowed. One year since Taxane and Herceptin treatment.

• Cumulative life-time dose of doxorubicin is greater than 360 mg/m^2

• Concurrent immunotherapy or hormonal therapy

• Parenchymal brain metastases, if present, must be documented to be clinically and radiographically stable for at least 6 months after treatment

• Serious intercurrent medical or psychiatric illness, including serious active infection

• History of congestive heart failure

• History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer

• Patients who have received an investigational drug within the previous 3 weeks

• Patient is currently enrolled in another clinical study receiving investigational therapies

• Pregnant or nursing women