Status:
UNKNOWN
Validate Gene Expression and Proteomic Signatures Predictive of Treatment for Response for Breast Cancer Patient
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Primary Objectives 1. Validate our previously generated tumor gene expression and proteomic profiles in this independent sample to determine the predictive power to distinguish good from poor clinica...
Detailed Description
Many chemotherapeutic agents are active in breast cancer, although response rate to any individual drug is only 30-50%. The choice of chemotherapy is empirical, and development of a chemosensitivity a...
Eligibility Criteria
Inclusion
- Patients may be included in the study only if they meet all of the following criteria:
- Female, age 18 years or above.
- Histologic or cytologic diagnosis of breast carcinoma.
- T2-4 breast cancer with measurable primary breast tumor, defined as palpable tumor with both diameters 2.0cm or greater as measured by caliper.
- Patients must not have received prior chemotherapy or hormonal therapy for the treatment of breast cancer.
- Karnofsky performance status of 70 or higher.
- Estimated life expectancy of at least 12 weeks.
- Adequate organ function including the following:
- Bone marrow:
- Absolute neutrophil (segmented and bands) count (ANC)\>= 1.5 x 10 9/L
- Platelets \>= 100 x 10 9/L
- Hepatic:
- Bilirubin \<= 1.5 x upper limit of normal (ULN),
- ALT or AST \<= 2.5x ULN, (or \<= 5 X with liver metastases)
- Renal:
- creatinine \<= 1.5x ULN
- Left ventricular ejection fraction \>= 50%
- Signed informed consent from patient or legal representative.
- Patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device, birth control pills, or barrier device) during and for three months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
Exclusion
- Patients will be excluded from the study for any of the following reasons:
- Prior treatment for locally advanced or metastatic breast cancer.
- Treatment within the last 30 days with any investigational drug.
- Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- Pregnancy.
- Breast feeding.
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Poorly controlled diabetes mellitus.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Symptomatic brain metastasis.
- History of significant neurological or mental disorder, including seizures or dementia.
- Peripheral neuropathy of CTC grade 2 or above (NCI CTC version 3).
- History of hypersensitivity to drugs formulated in Tween 80, the vehicle used for commercial docetaxel formulations.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00669773
Start Date
February 1 2007
End Date
February 1 2014
Last Update
December 10 2013
Active Locations (1)
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1
National University Hospital
Singapore, Singapore