Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
92 participants
OBSERVATIONAL
2018-03-01
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Real-Time PCR
Genomic DNA was extracted from 2 ml of venous blood. ABCB1 1236 G\>A and 3435 G\>A were genotyped using predesigned TaqMan SNP genotyping assays on a stepOne PCR instrument in accordance with the manufacturer's protocol.
Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed Breast Cancer.
3. Receiving conventional neoadjuvant or adjuvant weekly paclitaxel.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
5. Adequate organ reserves ((serum creatinine ≤1.5x upper normal limit (UNL), total bilirubin ≤1.5x UNL, absolute neutrophil count ≥1.5 x 10\^9/L, platelet count ≥100 x 10\^9/L, AST and ALT ≤3.0x UNL, and alkaline phosphatase ≤3.0x UNL).
6. No major neurological disease or symptoms prior to the start of paclitaxel therapy.
7. neither subjective nor objective evidence of metastatic disease.
Exclusion Criteria
2. Patients with recurrent or metastatic (local or distant) breast cancer.
3. Neuropathic at the time of recruitment.
4. History of neuropathy prior to recruitment.
5. Previously exposed to taxanes or any other microtubule Inhibitors, or regimens including platinates.
6. Patients currently receiving dose-dense biweekly taxane-containing regimens.
18 Years
FEMALE
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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nabil mahmoud
Master's Student
Locations
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Nasser's Institute Hospital
Cairo, Aghakhan, Egypt
Countries
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References
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Green H, Soderkvist P, Rosenberg P, Mirghani RA, Rymark P, Lundqvist EA, Peterson C. Pharmacogenetic studies of Paclitaxel in the treatment of ovarian cancer. Basic Clin Pharmacol Toxicol. 2009 Feb;104(2):130-7. doi: 10.1111/j.1742-7843.2008.00351.x. Epub 2008 Dec 16.
Kimchi-Sarfaty C, Marple AH, Shinar S, Kimchi AM, Scavo D, Roma MI, Kim IW, Jones A, Arora M, Gribar J, Gurwitz D, Gottesman MM. Ethnicity-related polymorphisms and haplotypes in the human ABCB1 gene. Pharmacogenomics. 2007 Jan;8(1):29-39. doi: 10.2217/14622416.8.1.29.
Rivera E, Cianfrocca M. Overview of neuropathy associated with taxanes for the treatment of metastatic breast cancer. Cancer Chemother Pharmacol. 2015 Apr;75(4):659-70. doi: 10.1007/s00280-014-2607-5. Epub 2015 Jan 18.
Scripture CD, Figg WD, Sparreboom A. Peripheral neuropathy induced by paclitaxel: recent insights and future perspectives. Curr Neuropharmacol. 2006 Apr;4(2):165-72. doi: 10.2174/157015906776359568.
Gao B, Russell A, Beesley J, Chen XQ, Healey S, Henderson M, Wong M, Emmanuel C, Galletta L, Johnatty SE, Bowtell D; Australian Ovarian Cancer Study Group; Haber M, Norris M, Harnett P, Chenevix-Trench G, Balleine RL, deFazio A. Paclitaxel sensitivity in relation to ABCB1 expression, efflux and single nucleotide polymorphisms in ovarian cancer. Sci Rep. 2014 May 9;4:4669. doi: 10.1038/srep04669.
Sparreboom A, van Tellingen O, Nooijen WJ, Beijnen JH. Preclinical pharmacokinetics of paclitaxel and docetaxel. Anticancer Drugs. 1998 Jan;9(1):1-17. doi: 10.1097/00001813-199801000-00001.
Wolking S, Schaeffeler E, Lerche H, Schwab M, Nies AT. Impact of Genetic Polymorphisms of ABCB1 (MDR1, P-Glycoprotein) on Drug Disposition and Potential Clinical Implications: Update of the Literature. Clin Pharmacokinet. 2015 Jul;54(7):709-35. doi: 10.1007/s40262-015-0267-1.
Tulsyan S, Mittal RD, Mittal B. The effect of ABCB1 polymorphisms on the outcome of breast cancer treatment. Pharmgenomics Pers Med. 2016 Apr 27;9:47-58. doi: 10.2147/PGPM.S86672. eCollection 2016.
Cavaletti G, Marmiroli P. Chemotherapy-induced peripheral neurotoxicity. Nat Rev Neurol. 2010 Dec;6(12):657-66. doi: 10.1038/nrneurol.2010.160. Epub 2010 Nov 9.
Other Identifiers
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ABCB1 in Paclitaxel Neuropathy
Identifier Type: -
Identifier Source: org_study_id