Clinical trial · Observational
Study of ABCB1,SLC22A16 Drug Transporter Genes and Doxorubicin and Cyclophosphamide Toxicity in Brest Cancer Patient
Associations Between Genetic Polymorphisms of Drug Transporter Genes and Toxicity of Doxorubicin and Cyclophosphamide Chemotherapy in Breast Cancer Patients
NCT04654195CI-TRIAL-00048629unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
polymorphisms of drug transporter genes may influence of Doxorubicin-Cyclophosphamide toxicity in breast cancer patients. the investigators want to evaluate the association between associations between genetic polymorphisms of ABCB1,SLC22A16 Genes and Toxicity of Doxorubicin and Cyclophosphamide Chemotherapy in Breast Cancer Patients treated by Doxorubicin-Cyclophosphamide regimen therapy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin-Cyclophosphamide regimen | Drug | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- .1-The frequency of the genetic polymorphisms of ABCB1 in breast cancer patien
- timeFrame
- up to 24 week
- description
- the blood samples will be DNA extracted using DNA extraction kit then single nucleotide polymorphisms of CYP2C19 gene will be detected by real time PCR
- measure
- The frequency of the genetic polymorphisms of SLC22A16 in breast cancer patients
- timeFrame
- up to 24 week
- description
- the blood samples will be DNA extracted by DNA extraction kit then single nucleotide polymorphisms of SL22A16 gene will be detected by real time PCR
Secondary outcomes (2)
- measure
- Correlation between genetic polymorphisms of ABCB1 and toxicities from Doxorubicin-Cyclophosphamide regimen therapy
- timeFrame
- up to 24 week
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. women who has confirmed diagnosis of breast cancer. 2. patient who will be treated with cyclophosphamide and doxorubicin(AC) regimen only . 3. patient take drug regimen for first time. Exclusion Criteria: \- 1. Patients with metastatic disease and with other previous tumors were excluded from this study 2. Pregnant or nursing female. 3. The patients who were diagnosed with cardiovascular disease or with low left ventricular ejection fraction. 4 .patients who had benign breast cancers, or had no clinical pathological information
References
Publications (4)
- BACKGROUNDTecza K, Pamula-Pilat J, Lanuszewska J, Butkiewicz D, Grzybowska E. Pharmacogenetics of toxicity of 5-fluorouracil, doxorubicin and cyclophosphamide chemotherapy in breast cancer patients. Oncotarget. 2018 Jan 10;9(10):9114-9136. doi: 10.18632/oncotarget.24148. eCollection 2018 Feb 6. PMID 29507678
- BACKGROUNDLudovini V, Antognelli C, Rulli A, Foglietta J, Pistola L, Eliana R, Floriani I, Nocentini G, Tofanetti FR, Piattoni S, Minenza E, Talesa VN, Sidoni A, Tonato M, Crino L, Gori S. Influence of chemotherapeutic drug-related gene polymorphisms on toxicity and survival of early breast cancer patients receiving adjuvant chemotherapy. BMC Cancer. 2017 Jul 26;17(1):502. doi: 10.1186/s12885-017-3483-2. PMID 28747156
- BACKGROUND3-U.S. department of health and human services(2017): Common Terminology Criteria for Adverse Events (CTCAE),National Cancer Institute ,2017,pp(4-6 ) ,pp(24-44).
- BACKGROUNDIslam MS, Islam MS, Parvin S, Ahmed MU, Bin Sayeed MS, Uddin MM, Hussain SM, Hasnat A. Effect of GSTP1 and ABCC4 gene polymorphisms on response and toxicity of cyclophosphamide-epirubicin-5-fluorouracil-based chemotherapy in Bangladeshi breast cancer patients. Tumour Biol. 2015 Jul;36(7):5451-7. doi: 10.1007/s13277-015-3211-y. Epub 2015 Feb 13. PMID 25677905