Genetic Markers of Circulating Tumor DNA for Monitoring Breast Cancer Patients in Costa Rica

Metastatic Breast Cancer Clinical Trial

Official title:

Genetic Markers of Circulating Tumor DNA for Monitoring Breast Cancer in Patients of the Hospital San Juan de Dios From 2018 to 2020.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04163159
• Other study ID #: R018-SABI-00193
• Secondary ID: B9316
• Status: Recruiting
• Start date: January 7, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: November 2019
• Source: Universidad de Costa Rica
• Contact: Ricardo Chinchilla
• Phone: +50625113483
• Email: ricardo.chinchilla_m[@]ucr.ac.cr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The use of circulating tumor DNA (ctDNA) as a noninvasive test for breast cancer monitoring throughout the course of the disease

Description:

The concentrations of the cell free DNA (cfDNA) and somatic mutations in circulating tumor DNA (ctDNA) in serial samples correlate with the number of days of the progression-free period and with the overall survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: November 30, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Metastatic breast cancer before the start of chemotherapeutic treatment

Exclusion Criteria:

• Patients with incomplete clinical records

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer
• Mutation, Point

Locations

Country	Name	City	State
Costa Rica	Hospital San Juan de Dios	San José

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Costa Rica

Country where clinical trial is conducted

Costa Rica, 

References & Publications (10)

Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. — View Citation

Dawson SJ, Tsui DW, Murtaza M, Biggs H, Rueda OM, Chin SF, Dunning MJ, Gale D, Forshew T, Mahler-Araujo B, Rajan S, Humphray S, Becq J, Halsall D, Wallis M, Bentley D, Caldas C, Rosenfeld N. Analysis of circulating tumor DNA to monitor metastatic breast cancer. N Engl J Med. 2013 Mar 28;368(13):1199-209. doi: 10.1056/NEJMoa1213261. Epub 2013 Mar 13. — View Citation

Diaz LA Jr, Bardelli A. Liquid biopsies: genotyping circulating tumor DNA. J Clin Oncol. 2014 Feb 20;32(6):579-86. doi: 10.1200/JCO.2012.45.2011. Epub 2014 Jan 21. Review. — View Citation

García-Saenz JA, Ayllón P, Laig M, Acosta-Eyzaguirre D, García-Esquinas M, Montes M, Sanz J, Barquín M, Moreno F, Garcia-Barberan V, Díaz-Rubio E, Caldes T, Romero A. Tumor burden monitoring using cell-free tumor DNA could be limited by tumor heterogeneity in advanced breast cancer and should be evaluated together with radiographic imaging. BMC Cancer. 2017 Mar 22;17(1):210. doi: 10.1186/s12885-017-3185-9. — View Citation

Goss PE, Lee BL, Badovinac-Crnjevic T, Strasser-Weippl K, Chavarri-Guerra Y, St Louis J, Villarreal-Garza C, Unger-Saldaña K, Ferreyra M, Debiasi M, Liedke PE, Touya D, Werutsky G, Higgins M, Fan L, Vasconcelos C, Cazap E, Vallejos C, Mohar A, Knaul F, Arreola H, Batura R, Luciani S, Sullivan R, Finkelstein D, Simon S, Barrios C, Kightlinger R, Gelrud A, Bychkovsky V, Lopes G, Stefani S, Blaya M, Souza FH, Santos FS, Kaemmerer A, de Azambuja E, Zorilla AF, Murillo R, Jeronimo J, Tsu V, Carvalho A, Gil CF, Sternberg C, Dueñas-Gonzalez A, Sgroi D, Cuello M, Fresco R, Reis RM, Masera G, Gabús R, Ribeiro R, Knust R, Ismael G, Rosenblatt E, Roth B, Villa L, Solares AL, Leon MX, Torres-Vigil I, Covarrubias-Gomez A, Hernández A, Bertolino M, Schwartsmann G, Santillana S, Esteva F, Fein L, Mano M, Gomez H, Hurlbert M, Durstine A, Azenha G. Planning cancer control in Latin America and the Caribbean. Lancet Oncol. 2013 Apr;14(5):391-436. doi: 10.1016/S1470-2045(13)70048-2. — View Citation

Overman MJ, Modak J, Kopetz S, Murthy R, Yao JC, Hicks ME, Abbruzzese JL, Tam AL. Use of research biopsies in clinical trials: are risks and benefits adequately discussed? J Clin Oncol. 2013 Jan 1;31(1):17-22. doi: 10.1200/JCO.2012.43.1718. Epub 2012 Nov 5. — View Citation

PDQ Cancer Genetics Editorial Board. Genetics of Breast and Gynecologic Cancers (PDQ®): Health Professional Version. 2019 Oct 18. PDQ Cancer Information Summaries [Internet]. Bethesda (MD): National Cancer Institute (US); 2002-. Available from http://www.ncbi.nlm.nih.gov/books/NBK65767/ — View Citation

Uehiro N, Sato F, Pu F, Tanaka S, Kawashima M, Kawaguchi K, Sugimoto M, Saji S, Toi M. Circulating cell-free DNA-based epigenetic assay can detect early breast cancer. Breast Cancer Res. 2016 Dec 19;18(1):129. — View Citation

Yanagawa T, Kagara N, Miyake T, Tanei T, Naoi Y, Shimoda M, Shimazu K, Kim SJ, Noguchi S. Detection of ESR1 mutations in plasma and tumors from metastatic breast cancer patients using next-generation sequencing. Breast Cancer Res Treat. 2017 Jun;163(2):231-240. doi: 10.1007/s10549-017-4190-z. Epub 2017 Mar 10. — View Citation

Ye Q, Qi F, Bian L, Zhang SH, Wang T, Jiang ZF. Circulating-free DNA Mutation Associated with Response of Targeted Therapy in Human Epidermal Growth Factor Receptor 2-positive Metastatic Breast Cancer. Chin Med J (Engl). 2017 Mar 5;130(5):522-529. doi: 10.4103/0366-6999.200542. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of circulating free DNA (cfDNA) concentration (in ng/uL) obtained from peripheral blood (liquid biopsy).	Samples will be analyze with Real time PCR and fluorometric assay and compare with overall survival	12 months
Primary	Number of somatic mutation findings in circulating free DNA (cfDNA) obtained from peripheral blood (liquid biopsy)	Samples will be analyze with targeted NGS sequencing panel	12 months
Secondary	Estrogen Receptor (ER), Progesterone Receptor (PR), Human Epidermal Growth Factor Receptor 2 (HER2) status	ER, PR, HER2 status	24 months
Secondary	Overall survival of participant	Overall survival of participant	24 months
Secondary	Cancer stage of participant	Cancer stage of participant	24 months