Clinical Application of ctDNA Dynamic Monitoring in Neoadjuvant Therapy for HER2-positive Breast Cancer Patients

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Jun 24, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a special test called circulating tumor DNA (ctDNA) can help doctors understand how well treatment is working for women with a specific type of breast cancer known as HER2-positive breast cancer. The study aims to see if ctDNA can predict how patients will respond to neoadjuvant therapy, which is treatment given before surgery to shrink tumors. By monitoring ctDNA levels during treatment, researchers hope to find out more about the best ways to manage this type of cancer.

To participate in the trial, women aged 18 to 75 who have been diagnosed with early or locally advanced HER2-positive breast cancer may be eligible, as long as they have not started any treatment yet. Participants should be able to meet certain health criteria and have measurable tumors. If enrolled, participants can expect to undergo regular monitoring and follow-up visits to track their progress throughout the study. It's important to note that women with advanced breast cancer, other active cancers, or certain serious health issues may not be eligible for this trial.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Women with breast cancer diagnosed clinically and pathologically, aged 18-75 years;
• • 2. ECOG performance score is 0-1;
• • 3. Histologically confirmed as early or locally advanced invasive breast cancer: the diameter of the primary tumor is more than 2 cm, and HER2 is positive (confirmed by IHC or FISH).
• • 4. The patient did not receive any treatment for breast cancer before enrollment;
• • 5. Having lesions measurable according to RECIST 1.1 standards;
• • 6. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up; 7) Breast cancer patients who plan to use neoadjuvant therapy.
• • Exclusion criteria
• • 1. Patients with known metastatic or stage IV breast cancer;
• • 2. There are other untreated malignant tumors other than breast cancer;
• • 3. Patients with one or more serious systemic diseases that, in the eyes of researchers, can impair their ability to complete research;
• • 4. According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors, which may affect the safety of the subjects or the collection of experimental data.
• • 5. Unable to follow up with the study according to the determined clinical follow-up period;
• • 6. Cannot accept or provide specified efficacy evaluation methods such as CT.
• • 7. Unable to obtain sufficient tumor tissue samples or peripheral blood samples.
• Exclusion Criteria:
• • - 1) Patients with known metastatic or stage IV breast cancer; 2) There are other incurable malignant tumors present; 3) One or more serious systemic diseases that, in the eyes of researchers, can impair the patient's ability to complete the study; 4) According to the researcher's judgment, there are other factors that may cause the subject to be forced to terminate the study midway, such as other serious illnesses (including mental illness) requiring concurrent treatment, severe abnormal laboratory test values, family or social factors, which may affect the safety of the subject or the collection of trial data.
• • 5) Unable to follow the determined clinical follow-up period in conjunction with the study for follow-up; 6) Unable to accept or provide specified efficacy evaluation methods such as CT.