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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00093145

Run by

Celgene

People needed

32

Starts

2004-06-01

Expected to finish

2008-10-01

Last updated by the study team

2019-11-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Breastlink Med Group — Long Beach, California, United States
• Hematology/Oncology P.C. Carl & Dorothy Bennet Cancer Center — Stamford, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Lombardi Cancer Center Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Florida Cancer Institute — Hudson, Florida, United States
• Gulf Coast Oncology Associates — St. Petersburg, Florida, United States
• Palm Beach Cancer Institute — West Palm Beach, Florida, United States
• Gerogia Cancer Specialist — Atlanta, Georgia, United States
• Maine Center for Cancer Medicine and Blood Disorders — Scarborough, Maine, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• University of Pittsburgh Medical Center Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Southwest Regional Cancer Center — Austin, Texas, United States
• Swedish Medical Center Cancer Institute Research — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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