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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04768426
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Breast Cancer Drug: Capecitabine Phase 2

Detailed Description:

The Primary Objective is to characterize the circulating tumor DNA (ctDNA) profile of triple-negative breast cancer (TNBC) in participants with residual disease after standard neoadjuvant chemotherapy (NAC) receiving standard-of-care adjuvant capecitabine.

The Secondary Objectives are to correlate ctDNA levels with genomic features and survival.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 3, 2021
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Capecitabine
1000 mg/m2 administered on Days 1 to 14 of 21-day cycles
Drug: Capecitabine
1000 mg/m2 administered on Days 1 to 14 of 21-day treatment cycles, for 8 cycles.
Other Name: fluoropyrimidine carbamate




Primary Outcome Measures :
  1. Baseline levels of ctDNA detection [ Time Frame: 6 months ]

    In participants with triple-negative breast cancer (TNBC) who have received standard neoadjuvant chemotherapy (NAC), levels of circulating tumor DNA (ctDNA) will be assessed at baseline and after 6 months of standard adjuvant capecitabine treatment. The outcome will be reported as the number of participants who are:

    • ctDNA+ (ctDNA-positive) at baseline and at 6 months.
    • ctDNA+ at baseline but ctDNA- (ctDNA-negative) at 6 months.
    • ctDNA- at baseline and at 6 months.
    • ctDNA- at baseline but ctDNA+ at 6 months.

    The outcome is a number without dispersion.



Secondary Outcome Measures :
  1. Correlation of ctDNA levels with genomic features of tumor [ Time Frame: 24 weeks ]

    Genomic status of certain mutations in the tumor will be assessed by next-generation sequencing in participants who are:

    • ctDNA+ (ctDNA-positive) at baseline and at 6 months.
    • ctDNA+ at baseline but ctDNA- (ctDNA-negative) at 6 months.
    • ctDNA- at baseline and at 6 months.
    • ctDNA- at baseline but ctDNA+ at 6 months.

    The genes of interest are:

    PIK3CA AKT AKT1 PTEN BRCA1 BRCA2 PALB2 CHEK2 ATM NBN BRIP1 BARD1 MRE11 ATR RAD50 RAD51C RAD51D FANCA FANCC FANCD2 FANCE FANCF FANCG FANCL.

    The outcome will be reported as the number of participants with a positive mutation status in the gene of interest. The outcome is a number without dispersion.


  2. Overall Survival (OS) [ Time Frame: 5 years ]
    Overall survival (OS) will be assessed as participants remaining alive 5 years from the first treatment initiation. The outcome is reported as the number of participants alive (without dispersion).

  3. Relapse-Free Survival [ Time Frame: 5 years ]
    Relapse-free survival is defined as the time from treatment initiation to first invasive relapse or death, through 5 years. The outcome is reported as the number of participants with relapse-free survival (without dispersion) at 5 years.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Anatomic stage I - III triple-negative breast cancer at diagnosis
  2. Estrogen receptors (ER) and Progesterone receptors (PR) status <10%
  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. ≥ 18 years of age
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  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. No evidence of metastatic disease.
  8. A minimum 4-week wash out from previous chemotherapy treatment is required.
  9. Adequate hematologic function: Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3)
  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. Adequate renal function: Serum creatinine ≤ 1.5 x ULN; or calculated creatinine clearance > 50 mL/min using the Cockcroft Gault formula.
  12. Planned for 6 months or 8 cycles of adjuvant capecitabine.
  13. Women of childbearing potential (WOCBP) must have a negative pregnancy test.
  14. WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.
  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. Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Exclusion Criteria:

  1. Metastatic breast cancer
  2. Has not had definitive surgical resection
  3. Pregnant or breastfeeding
  4. Has not completed definitive adjuvant radiation if planned
  5. Known human immunodeficiency virus (HIV) positivity or active hepatitis B or C.
  6. Investigational agents within 4 weeks of study initiation
  7. Inability to swallow oral medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04768426


Contacts
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Contact: Cindy Garcia 650-497-1681 cinmaig@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94304
Contact: Cindy Garcia    650-497-1681    cmaigarcia@stanford.edu   
Principal Investigator: Melinda Telli, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Melinda Telli Stanford Universiy
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04768426    
Other Study ID Numbers: IRB-57723
BRS0121 ( Other Identifier: OnCore )
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Stanford University:
TNBC
Triple Negative Breast Cancer
Post neoadjuvant
Residual disease
Capecitabine
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents