Status:
COMPLETED
Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer
Lead Sponsor:
Celgene
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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), Carboplati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00093145
Start Date
June 1 2004
End Date
October 1 2008
Last Update
November 25 2019
Active Locations (14)
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1
Breastlink Med Group
Long Beach, California, United States, 90806
2
Hematology/Oncology P.C. Carl & Dorothy Bennet Cancer Center
Stamford, Connecticut, United States, 06902
3
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
4
Lombardi Cancer Center Georgetown University Hospital
Washington D.C., District of Columbia, United States, 2007