Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment

NCT06087120 | Recruiting

• 1 other identifier: GS_ZNAB
• Study Type: observational
• Target: 125
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Breast Cancer Female; Stage II Breast Cancer; Stage III Breast Cancer; HER2-positive Breast Cancer; Triple Negative Breast Cancer

Keywords

Liquid Biopsy; Circulating Tumour DNA; Vietnam; Indonesia

Outcome Measures

Primary Outcomes (2)

• 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.

  12 months following up.

• 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.

  12 months following up.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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, MRCCC Siloam Hospitals Semanggi (Indonesia).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gene Solutions: lead

Study Sites (3)

MRCCC Siloam Hospitals Semanggi

Jakarta, Indonesia

RECRUITING

Medical Genetics Institute

Ho Chi Minh City, Vietnam

RECRUITING

University Medical Center HCMC

Ho Chi Minh City, Vietnam

RECRUITING

Related Publications (20)

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Related Links

• Health Mo: Decision No. 3128/QD-BYT on the issuance of GUIDES FOR DIAGNOSIS AND TREATMENT OF BREAST CANCER. 2020.

Biospecimen

Retention: SAMPLES WITH DNA

The 1st samples are collected from participants of Breast cancer, phase II-III, HER2+ /or Triple Negative breast cancer will be processed and analyzed to determine detection rate of ctDNA in the blood samples before neoadjuvant chemotherapy. The 2nd and 3rd samples are collected from participants will be processed and analyzed to determine the change of ctDNA in the blood samples during and after neoadjuvant chemotherapy.

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sinh D Nguyen, PHD

  MGI

  PRINCIPAL INVESTIGATOR

• Trung Q Lam, MD

  University medical center HCMC

  PRINCIPAL INVESTIGATOR

• Samuel J Haryono, MD

  MRCCC Siloam Hospitals Semanggi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lan NL Tu, PHD

CONTACT

+84888843489; lantu@genesolutions.vn

Van T. Phan, MSc

CONTACT

+84908145990; vanphan@genesolutions.vn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: September 16, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Feb 2026
• Access Criteria: GS\ ZNAB\ ctDNA for Breast cancer

Locations

ID (1); VN (2)