Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.

October 16, 2023 updated by: Gene Solutions

Investigate the Prognostic and Predictive Value of Circulating Tumor DNA (ctDNA) During Neoadjuvant Chemotherapy for Breast Cancer.

This is a prospective and observational study, aiming to determine the detection rate and change of CtDNA in blood samples of cancer patients before, during and after neoadjuvant treatment.

  • Determine the rate of ctDNA positivity at the time before treatment,
  • Determine the rate of ctDNA positivity at the time during treatment,
  • Determine the rate of ctDNA positivity at the time after neoadjuvant therapy, whether there is a change in ctDNA expression of the study population during treatment.

And aiming to investigate the relationship between ctDNA expression and MRI imaging with pCR response in neo-adjuvant therapy:

  • Correlation between ctDNA detection and pCR response. Determine the percentage of Positive Prediction Value - PPV, Negative Prediction Value - NPV of ctDNA,
  • Correlation between MRI imaging and pCR response. Determination of PPV, NPV of MRI
  • Combination of ctDNA detection and MRI imaging in the prognosis of pCR. Determination of PPV, NPV ratio of ctDNA combined with MRI.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is a prospective and observational study recruiting Female participants aged 18 and older, who are diagnosed with stage II-III HER+/Triple Negative Breast cancer and indicated for neoadjuvant chemotherapy at University Medical Center HCMC, had FFPE sample at the time of diagnosis and operation. This study is conducted at the Medical Genetics Institute (MGI), in collaboration with the University Medical Center HCMC.

Eligible neoadjuvant chemotherapy (NAC) / treatment regimen for the study:

  • AC-T (Doxorubicin, Cyclophosphamid - Taxane).
  • AC-TH (Doxorubicin, Cyclophosphamid - Taxane - Trastuzumab).
  • TCH (Docetaxel - Carboplatin - Trastuzumab).
  • TCHP (Docetaxel - Carboplatin - Trastuzumab - Pertuzumab).

Patients are allowed to change protocol if required clinically.

The potential and voluntary participants, satisfy all the inclusion/exclusion criteria will be recruited into this study.

At enrollment, each participant will answer to the pre-designed questionnaires of demographic information, medical history.

At routine visits, the participants' clinical information and routine para-clinical results such as breast ultrasound or MRI or CT scan, chest x-ray, mamography, bone or PET-CT scan, CA 15-3 will be collected by Physicians.

Participant in this study will have samples collected the following period of time.

  • At enrollment (Pre-NAC, at diagnosis): 10ml of peripheral blood for ctDNA analysis and 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples collected as biopsy before treatment.
  • During NAC, 10ml of peripheral blood will be collected for ctDNA analysis and Ultrasound scan of neck, breast, abdomen and pelvis; chest x-ray, CA15-3; CT Scan of the neck, abdomen and pelvis (if any) will be also collected.
  • Post-NAC, 10ml of peripheral blood will be collected for ctDNA analysis and Ultrasound scan of neck, breast, abdomen and pelvis; chest x-ray, CA15-3; CT Scan of the neck, abdomen and pelvis, PET-CT scan (if any) will be also collected to compare to treatment respondence between ctDNA and imaging groups.
  • After surgery, 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples collected.

The study end date of a participant is estimated 1 year since enrollment date.

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Recruiting
        • University Medical Center HCMC
        • Contact:
          • Trung Q Lam, MD
        • Principal Investigator:
          • Trung Q Lam, MD
      • Ho Chi Minh City, Vietnam
        • Recruiting
        • Medical Genetics Institute
        • Contact:
        • Principal Investigator:
          • Sinh D. Nguyen, PhD. MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include female, from 18 years old or above, who are diagnosed with stage II-III HER2+/Triple Negative breast cancer and indicated for neoadjuvant chemotherapy. Eligible participants will meet all of the inclusion and exclusion criteria to be recruited into this study at University Medical Center HCMC.

Description

Inclusion Criteria:

  • Female,18 years old and older,
  • Are diagnosed with stage II-III HER2+/Triple Negative breast cancer and indicated for neoadjuvant chemotherapy,
  • FFPE sample is available at the time of diagnosis and operation,
  • Are voluntary to participate in the study.

Exclusion Criteria:

  • Recurrent breast cancer,
  • Other cancer metastasis to the breast,
  • Have been or are being treated for cancer,
  • Patients did not agree to participate in the studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the detection rate and change of ctDNA in blood samples of cancer patients before, during, and after neoadjuvant treatment.
Time Frame: 12 months following up.
  • Determine the rate of ctDNA positivity at the time before treatment
  • Determine the rate of ctDNA positivity at the time during treatment
  • Determine the rate of ctDNA positivity at the time after neoadjuvant therapy whether there is a change in ctDNA expression of the study population during treatment.
12 months following up.
To investigate the relationship between ctDNA expression and MRI imaging with pCR response in neo-adjuvant therapy.
Time Frame: 12 months following up.
  • Correlation between ctDNA detection and pCR response. Determine the percentage of Positive Prediction Value - PPV, Negative Prediction Value - NPV of ctDNA,
  • Correlation between MRI imaging and pCR response. Determination of PPV, NPV of MRI,
  • Combination of ctDNA detection and MRI imaging in the prognosis of pCR, Determination of PPV, NPV ratio of ctDNA combined with MRI.
12 months following up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gene Solutions

Investigators

  • Principal Investigator: Sinh D Nguyen, PhD, MGI
  • Principal Investigator: Trung Q Lam, MD, University Medical Center HCMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

September 16, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS_ZNAB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised data of this study may be requested for publication by journals. Sharing anonymised data with suitable study will be decided by the sponsor, PIs and the authority agency where the data was collected. No identifiable information will be share with any other person/organization than authorized in the study.

IPD Sharing Time Frame

Feb 2026

IPD Sharing Access Criteria

GS_ZNAB_ctDNA for Breast cancer

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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