Monitoring circulating tumor DNA in HER2-positive breast cancer treatment
Director, Department of Pathology, Jiangsu Provincial People's Hospital
This study is testing if tracking tumor DNA in the blood can help women with HER2-positive breast cancer understand how well their treatment is working.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06479460 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enroll 50 women diagnosed with early or locally advanced HER2-positive breast cancer to investigate the predictive and prognostic value of circulating tumor DNA (ctDNA) during neoadjuvant therapy. Participants will provide baseline tumor tissue and peripheral blood samples at various stages of treatment, allowing researchers to analyze tumor mutations and ctDNA levels. The study seeks to determine how ctDNA can inform treatment efficacy and patient outcomes in this specific population.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-75 with early or locally advanced HER2-positive breast cancer who have not received prior treatment.
Not a fit: Patients with known metastatic breast cancer or other untreated malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict treatment responses and improve outcomes for patients with HER2-positive breast cancer.
How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring treatment responses in various cancers, suggesting potential success for this approach in breast cancer.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- Jiangsu Province Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Zhihone Zhang, Doctor of Medicine
- Email: zhangzhih2001@aliyun.com
- Phone: 18013348615
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.