NCT04163159

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

1.8 years

First QC Date

November 6, 2019

Last Update Submit

November 21, 2019

Conditions

Metastatic Breast CancerMutation, Point

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Estrogen Receptor (ER), Progesterone Receptor (PR), Human Epidermal Growth Factor Receptor 2 (HER2) status

    24 months

  • Overall survival of participant

    24 months

  • Cancer stage of participant

    24 months

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Metastasic breast cancer females

You may qualify if:

  • Metastatic breast cancer before the start of chemotherapeutic treatment

You may not qualify if:

  • Patients with incomplete clinical records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital San Juan de Dios

San José, 1000, Costa Rica

RECRUITING

Related 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. doi: 10.1056/NEJMoa040766.

    PMID: 15317891BACKGROUND

  • 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.

    PMID: 23484797BACKGROUND

  • 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.

    PMID: 24449238BACKGROUND

  • Garcia-Saenz JA, Ayllon P, Laig M, Acosta-Eyzaguirre D, Garcia-Esquinas M, Montes M, Sanz J, Barquin M, Moreno F, Garcia-Barberan V, Diaz-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.

    PMID: 28330468BACKGROUND

  • Goss PE, Lee BL, Badovinac-Crnjevic T, Strasser-Weippl K, Chavarri-Guerra Y, St Louis J, Villarreal-Garza C, Unger-Saldana 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, Duenas-Gonzalez A, Sgroi D, Cuello M, Fresco R, Reis RM, Masera G, Gabus R, Ribeiro R, Knust R, Ismael G, Rosenblatt E, Roth B, Villa L, Solares AL, Leon MX, Torres-Vigil I, Covarrubias-Gomez A, Hernandez 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.

    PMID: 23628188BACKGROUND

  • 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.

    PMID: 23129736BACKGROUND

  • PDQ Cancer Genetics Editorial Board. Genetics of Breast and Gynecologic Cancers (PDQ(R)): Health Professional Version. 2025 Mar 6. In: PDQ Cancer Information Summaries [Internet]. Bethesda (MD): National Cancer Institute (US); 2002-. Available from http://www.ncbi.nlm.nih.gov/books/NBK65767/

    PMID: 26389210BACKGROUND

  • 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. doi: 10.1186/s13058-016-0788-z.

    PMID: 27993161BACKGROUND

  • 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.

    PMID: 28283903BACKGROUND

  • 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.

    PMID: 28229982BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and whole blood samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Ricardo Chinchilla

CONTACT

+50625113483ricardo.chinchilla_m@ucr.ac.cr

Allan Ramos, Msc.

CONTACT

+50688448187allan.ramos@ucr.ac.cr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 14, 2019

Study Start

January 7, 2019

Primary Completion

October 31, 2020

Study Completion

November 30, 2020

Last Updated

November 25, 2019

Record last verified: 2019-11

Locations

CO(1)