A Phase 2 interventional study of Adriamycin and Docetaxel in Breast Cancer, sponsored by National University Hospital, Singapore. Status unknown at 1 site in Singapore. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-10.
Sponsored by National University Hospital, Singapore · Phase 2, Interventional, and Treatment
Primary Objectives
Secondary objectives
To correlate adriamycin and docetaxel pharmacokinetics with
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 assay is desirable, to reduce costs, unnecessary toxicity, and loss of window of opportunity to cure. Single molecular markers to predict sensitivity are not highly accurate, as chemotherapy resistance mechanisms likely involve complex pathways. High-throughput technologies such as gene expression microarray and Proteinchip array allow simultaneous analysis of thousands of genes, and hundreds of proteins, and may be more informative. We previously conducted a study on patients with measurable primary breast tumor who received primary chemotherapy with an alternating regimen of adriamycin and docetaxel, and generated tumor genomic and tumor and plasma proteomic signatures that predicted for clinical and pathological response using high throughput discovery platforms. This protocol aims to recruit 20 patients as an independent test set to validate the genomic and proteomic signatures generated previously. Half the patients will be randomized to receive 4 cycles of pre-operative adriamycin (Arm A) allowing validation of the adriamycin-specific signatures, while the other half will be randomized to receive 4 cycles of pre-operative docetaxel (Arm B) allowing validation of the docetaxel-specific signatures. Subjects will then undergo resection of the primary breast tumor, followed by 4 cycles of adjuvant therapy with the alternative drug (docetaxel in Arm A, adriamycin in Arm B). Serial tumor and plasma samples will be obtained for genomic and proteomic analysis. The previously generated genomic and proteomic signatures will be applied to this independent dataset to categorize patients into good and poor responders, and the prediction correlated with actual treatment responses. Secondary goals include the correlation of patient genotype with drug pharmacokinetics, and the correlation of chemotherapy-induced peripheral blood mononuclear cell gene expression changes with treatment response and toxicities
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 49 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.
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Patients may be included in the study only if they meet all of the following criteria:
Adequate organ function including the following:
Bone marrow:
Hepatic:
Renal:
Exclusion Criteria:
Patients will be excluded from the study for any of the following reasons:
Arm A: 4 cycles of adriamycin at 75mg/m2 3 weekly followed by surgery followed by 4 cycles of docetaxel at 75mg/m2 3 weekly
Drug: Adriamycin
Drug: Docetaxel
Arm A: 4 cycles of adriamycin at 75mg/m2 3 weekly followed by surgery followed by 4 cycles of docetaxel at 75mg/m2 3 weekly
Arm B: 4 cycles of docetaxel at 75mg/m2 3 weekly followed by surgery followed by 4 cycles of adriamycin at 75mg/m2 3 weekly.
Clinical and pathological response rate
Clinical and pathological response rate to four cycles of pre-operative chemotherapy.
Time frame: 12 weeks
Baseline and serial changes in tumor & plasma genomic and proteomic changes
Core biopsy of breast tumor before treatment, after one cycle of pre-operative chemotherapy, and after the fourth cycle of pre-operative chemotherapy or study withdrawal for a total of 3 core biopsies. Plasma samples for proteomics before treatment, during pre-operative chemotherapy and before surgery, before first cycle of post-operative chemotherapy, within 4 weeks after completion of 4 cycles of post-operative chemotherapy, and four monthly thereafter.
Time frame: at different time-points (see description below)
This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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National University Hospital, Singapore