Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorGene Solutions

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months following up.
2

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.

Time frame
12 months following up.

Secondary outcomes

Other outcomes

Sponsors and contacts

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