RECRUITING

Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer

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Conditions

Triple Negative Breast CancerBreast CancerTNBCPost neoadjuvantResidual diseaseCapecitabine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to evaluate the use of a circulating tumor DNA (ctDNA) assay, ie, a "liquid biopsy," as a tool to identify triple-negative breast cancer (TNBC) patients who will or will not experience benefit from treatment with capecitabine. Participants will be monitored for changes in ctDNA in the blood over time received during capecitabine treatment. Results of ctDNA analysis will be correlated to genetic characteristics of individual tumors. This may inform future clinical trials in which patients could receive a different treatment than capecitabine to reduce their risk of breast cancer relapse.

Official Title

Phase II Trial of Circulating Tumor DNA Monitoring During Adjuvant Capecitabine in Patients With Triple-negative Breast Cancer and Residual Disease Following Standard Neoadjuvant Chemotherapy

Quick Facts

Study Start:2021-02-03
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04768426

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Anatomic stage I - III triple-negative breast cancer at diagnosis
  2. 2. Estrogen receptors (ER) and Progesterone receptors (PR) status \<10%
  3. 3. Residual disease following at least 4 cycles of neoadjuvant chemotherapy. Patients who received other investigational immunotherapy or targeted therapy during the neoadjuvant phase of treatment are eligible.
  4. 4. ≥ 18 years of age
  5. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  6. 6. All clinically significant toxic effects of prior cancer therapy resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE, v 5.0), except alopecia and G2 neuropathy.
  7. 7. No evidence of metastatic disease.
  8. 8. A minimum 4-week wash out from previous chemotherapy treatment is required.
  9. 9. Adequate hematologic function: Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3)
  10. 10. Adequate hepatic function: Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN). Exception: If Gilbert's syndrome; then ≤ 5 times ULN. Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN
  11. 11. Adequate renal function: Serum creatinine ≤ 1.5 x ULN; or calculated creatinine clearance \> 50 mL/min using the Cockcroft Gault formula.
  12. 12. Planned for 6 months or 8 cycles of adjuvant capecitabine.
  13. 13. Women of childbearing potential (WOCBP) must have a negative pregnancy test.
  14. 14. WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.
  15. 15. Male participants and their female partners of child bearing potential must be willing to use an appropriate method of contraception during the study and for 3 months after the last dose.
  16. 16. Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol
  1. 1. Metastatic breast cancer
  2. 2. Has not had definitive surgical resection
  3. 3. Pregnant or breastfeeding
  4. 4. Has not completed definitive adjuvant radiation if planned
  5. 5. Known human immunodeficiency virus (HIV) positivity or active hepatitis B or C.
  6. 6. Investigational agents within 4 weeks of study initiation
  7. 7. Inability to swallow oral medications

Contacts and Locations

Study Contact

Cindy Garcia
CONTACT
650-497-1681
cinmaig@stanford.edu

Principal Investigator

Melinda Telli
PRINCIPAL_INVESTIGATOR
Stanford Universiy

Study Locations (Sites)

Stanford University
Stanford, California, 94304
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Melinda Telli, PRINCIPAL_INVESTIGATOR, Stanford Universiy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-03
Study Completion Date2026-02

Study Record Updates

Study Start Date2021-02-03
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • TNBC
  • Triple Negative Breast Cancer
  • Post neoadjuvant
  • Residual disease
  • Capecitabine

Additional Relevant MeSH Terms

  • Triple Negative Breast Cancer
  • Breast Cancer