Status:
COMPLETED
Phase II Trial Comparing ABI-007 (Abraxane®, Nab®-Paclitaxel) to Taxotere in First Line Therapy of Patients With Stage IV Breast Cancer
Lead Sponsor:
Celgene
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This was an open-label study conducted comparing the toxicity and antitumor activity of ABI-007 (Abraxane®, nab®-paclitaxel) to docetaxel (Taxotere).
Detailed Description
This was an open-label, randomized study to compare the following regimens with respect to toxicity and antitumor activity: * the maximum tolerated dose (MTD) of ABI-007 300 mg/m\^2 every 3 weeks; * ...
Eligibility Criteria
Inclusion
- Patients had to meet the following criteria to be eligible for the study:
- Pathologically confirmed adenocarcinoma of the breast.
- No prior chemotherapy for metastatic breast cancer.
- Stage IV disease.
- Measurable disease (must have been ≥ 2.0 cm, except for pulmonary lesions that were well documented on CT scan that were ≥ 1.0 cm).
- At least 3 weeks since prior cytotoxic chemotherapy (patients should have recovered from all acute effects of such therapy.
- At least 4 weeks since radiotherapy, with full recovery. The measurable disease was completely outside the radiation portal or there was radiologic or clinical exam proof of progressive disease within the radiation portal.
- At least 4 weeks since major surgery, with full recovery.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Age ≥18 years.
- Patient had the following blood counts at Baseline:
- Absolute neutrophil count (ANC) ≥1.5\*10\^9 cells/L
- Platelets ≥100\*10\^9 cells/L
- Hemoglobin (Hgb) ≥9 g/dL.
- Patient had the following baseline blood chemistry levels:
- Aspartate aminotransferase (AST \[SGOT\]), alanine aminotransferase (ALT \[SGPT\])≥2.5x upper limit of normal (ULN) range
- Total bilirubin normal
- Alkaline phosphatase ≥2.5x ULN (unless bone metastasis is present in the absence of liver metastasis)
- Creatinine ≥1.5 mg/dL.
- Peripheral neuropathy Grade 0 or 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
- If female of childbearing potential, pregnancy test was negative (within 72 hours of the first dose of study drug).
- If fertile, the patient agreed to use an effective method to avoid pregnancy for the duration of the study.
- Informed consent had been obtained.
Exclusion
- Patients who met any of the following criteria were excluded from the study:
- Prior neo-adjuvant or adjuvant chemotherapy was allowed. No prior chemotherapy for metastatic disease was allowed. If a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen.
- Cumulative life-time dose of doxorubicin \>360 mg/m\^2. Doxorubicin was allowed as prior neo-adjuvant or adjuvant therapy but not for metastatic disease.
- Concurrent immunotherapy or hormonal therapy for breast cancer.
- Parenchymal brain metastases, unless 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 class II-IV congestive heart failure.
- History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.
- Patients who had received an investigational drug within the previous 3 weeks.
- Patient was enrolled in a different clinical study in which investigational procedures were performed or investigational therapies were administered. Also, a patient was not permitted enroll in such clinical trials while participating in this study.
- Pregnant or nursing women
- Patients with prior hypersensitivity to either Taxol or Taxotere.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT00274456
Start Date
November 1 2005
End Date
July 1 2011
Last Update
November 21 2019
Active Locations (1)
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1
Study Sites in Russia and the Ukraine
Kiev, Ukraine, 01021