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Blood test may tell if breast cancer chemo is working

NCT ID NCT06087120

Knowledge-focused Sponsor: Gene Solutions Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is testing whether a blood test that looks for tumor DNA (ctDNA) can help predict how well breast cancer responds to chemotherapy given before surgery. Researchers will take blood samples from 125 women with stage II or III breast cancer before, during, and after treatment. They will compare the blood test results with MRI scans and final tumor removal to see if ctDNA can reliably show whether the cancer is gone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple blood test that helps doctors know early whether chemotherapy is working for breast cancer patients.
What could go wrong
This is an observational study, not a treatment trial. It is small (125 people) and only looks at certain breast cancer types, so results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm female breast carcinoma HER2 positive breast carcinoma triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer female HER2-positive breast cancer Stage II breast cancer Stage III breast cancer Triple negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • MRCCC Siloam Hospitals Semanggi

    RECRUITING

    Jakarta, Indonesia

  • Medical Genetics Institute

    RECRUITING

    Ho Chi Minh City, Vietnam

  • University Medical Center HCMC

    RECRUITING

    Ho Chi Minh City, Vietnam

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