Clinical trial NCT06087120: Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
Official title: Investigate the Prognostic and Predictive Value of Circulating Tumor DNA (ctDNA) During Neoadjuvant Chemotherapy for Breast Cancer.
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Gene Solutions
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the detection rate and change of ctDNA in blood samples of cancer patients before, during, and after neoadjuvant treatment.
timeFrame: 12 months following up.
measure: To investigate the relationship between ctDNA expression and MRI imaging with pCR response in neo-adjuvant therapy.
timeFrame: 12 months following up.
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Medical Genetics Institute
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center HCMC
Study officials:
affiliation: MGI
name: Sinh D Nguyen, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University medical center HCMC
name: Trung Q Lam, MD
role: PRINCIPAL_INVESTIGATOR
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