Current and future perspectives of liquid biopsies in genomics-driven oncology.
Ellen Heitzer, Imran S Haque, Charles E S Roberts...
https://pubmed.ncbi.nlm.nih.gov/30410101Actively Recruiting
Age: 18Years - 75Years
FEMALE
ID06479460
Clinical Application of ctDNA Dynamic Monitoring in Neoadjuvant Therapy for HER2-positive Breast Cancer Patients
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-07-24
50
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the role of circulating tumor DNA (ctDNA) in patients with HER2-positive breast cancer undergoing neoadjuvant therapy. The study focuses on exploring how ctDNA can predict treatment response and patient outcomes in early to locally advanced stages of this breast cancer type. This observational research aims to better understand the prognostic value of ctDNA to help guide future treatment decisions. The study will enroll 50 women diagnosed with HER2-positive breast cancer who have not yet received treatment. Researchers will collect tumor tissue samples and multiple peripheral blood samples before, during, and after neoadjuvant therapy, as well as after surgery. Using personalized panels based on tumor mutations, ctDNA in blood samples will be analyzed to assess treatment efficacy and prognosis without interfering with standard care. Participants will be involved through scheduled blood and tissue sample collections at various treatment stages. Researchers will evaluate outcomes such as the postoperative pathological complete response (pCR) rate. The study includes monitoring adherence and follow-up visits to collect necessary data. Participation is expected to last from the start of treatment until after surgery, with ongoing evaluations throughout the neoadjuvant therapy period.
CONDITIONS
Brief Title
Clinical Application of ctDNA Dynamic Monitoring in Neoadjuvant Therapy for HER2-positive Breast Cancer Patients
Who Can Participate
Age: 18Years - 75Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 75 years with clinically and pathologically confirmed breast cancer
- ECOG performance score of 0-1
- Histologically confirmed early or locally advanced invasive breast cancer with tumor diameter over 2 cm and HER2 positive status
- No prior treatment for breast cancer before enrollment
- Measurable lesions according to RECIST 1.1 standards
- Willing to participate voluntarily, able to comply with follow-up
- Planned to undergo neoadjuvant therapy for breast cancer
You will not qualify if you...
- Known metastatic or stage IV breast cancer
- Presence of other untreated malignant tumors besides breast cancer
- Serious systemic diseases impairing ability to complete the study
- Other serious illnesses or social/family factors that may interfere with study participation or safety
- Inability to follow the clinical follow-up schedule
- Unable or unwilling to undergo required efficacy evaluations such as CT scans
- Inability to provide sufficient tumor tissue or peripheral blood samples
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - From baseline through post-surgery period (several months)
Participants have peripheral blood samples collected at multiple timepoints before, during, and after neoadjuvant therapy as well as after surgery to detect ctDNA mutations without interfering with their clinical treatment.
Multiple blood sample collections at baseline, during therapy, before surgery, and after surgery
Trial Site Locations
Total: 1 location
1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
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Research Team
Z
Zhihone Zhang, Doctor of Medicine
J
Jing Wu, Doctor of Medicine
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Personalized circulating tumor DNA analysis to detect residual disease after neoadjuvant therapy in breast cancer.
Bradon R McDonald, Tania Contente-Cuomo, Stephen-John Sammut...
https://pubmed.ncbi.nlm.nih.gov/31391323Circulating Tumor DNA in HER2-Amplified Breast Cancer: A Translational Research Substudy of the NeoALTTO Phase III Trial.
Françoise Rothé, Maria Joao Silva, David Venet...
https://pubmed.ncbi.nlm.nih.gov/30862692Circulating Tumor DNA After Neoadjuvant Chemotherapy in Breast Cancer Is Associated With Disease Relapse.
Frédéric Cailleux, Elisa Agostinetto, Matteo Lambertini...
https://pubmed.ncbi.nlm.nih.gov/36170624Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival.
M J M Magbanua, L B Swigart, H-T Wu...
https://pubmed.ncbi.nlm.nih.gov/33232761