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Exploration of the predictive value of circulating tumor DNA for the efficacy of neoadjuvant therapy in early breast cancer

Exploration of the predictive value of circulating tumor DNA for the efficacy of neoadjuvant therapy in early breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500104810
Enrollment
Unknown
Registered
2025-06-24
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary breast cancer

Interventions

The test group:None
The control group:None

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18~70 years old; 2. Patients with primary breast cancer confirmed by pathology by fine needle or core needle aspiration biopsy. Have a clear measurable tumor lesion, the length and diameter of the lesion > 10 mm; 3. Have a complete general examination, excluding distant metastasis of tumors; 4. Systemic functional status PS (ECOG) score=10.0 g/dl, neutrophil count >=1.5×10^9/L, platelet count >=90×10^9/L; Blood biochemistry: serum total bilirubin =50%); 7. Not receiving anti-tumor chemoradiotherapy or endocrine therapy before neoadjuvant therapy; 8. Patients with occult breast cancer, which must be confirmed by pathology, and axillary lymph nodes can be used as measurable lesions; 9. Completed neoadjuvant therapy and surgical treatment, and have retained plasma samples before neoadjuvant therapy, after the second cycle of neoadjuvant therapy and three time points before surgery; 10. Previously signed consent form for neoadjuvant therapy and informed consent form for retained plasma specimens for clinical research.

Exclusion criteria

Exclusion criteria: 1.Neoadjuvant therapy or surgical treatment has not been completed; 2.Combined with other malignant tumors at the same time, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 3.The patient is accompanied by uncontrolled heart, lung and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases; 4.Chemotherapy, radiotherapy and endocrine therapy have been received before neoadjuvant therapy; 5.Patients during lactation and pregnancy; 6.Plasma samples were not retained during neoadjuvant therapy; 7.No previously signed consent form for neoadjuvant therapy and/or informed consent form for retention of plasma specimens for clinical research.

Design outcomes

Primary

MeasureTime frame
Clinicopathological characteristics;Pathological complete response,pCR;

Secondary

MeasureTime frame
Distant disease free survival(DDFS);Disease-free survival time(DFS);

Countries

China

Contacts

Public ContactLigang Niu

The First Affiliated Hospital of Xi'an Jiaotong University

niuligang838@sina.com+86 29 85324605

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026