Skip to content

Prediction of HR+HER2- neoadjuvant chemotherapy sensitivity in breast cancer based on full exon sequencing

Prediction of HR+HER2- neoadjuvant chemotherapy sensitivity in breast cancer based on full exon sequencing

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038577
Enrollment
Unknown
Registered
2020-09-24
Start date
2020-10-09
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

HR+HER2- breast cancer

Interventions

Neoadjuvant chemotherapy sensitive patients vs neoadjuvant chemotherapy resistant patients:

Sponsors

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Pathologically diagnosed breast cancer, women aged 18-75 years 2) The clinical stage is cT1-4N1-3M0 3) HR positive and HER2 negative. The positive threshold of ER, PR immunohistochemical test (IHC) is set to =1%, HER2 IHC 0-1 + or IHC 2+ and FISH test is negative; the expression level of Ki67 in tumor tissue is known before treatment, and the tissue can be processed Perform other biological and molecular tests 4) Receive at least two cycles of neoadjuvant chemotherapy 5) Receive subsequent mastectomy or breast-conserving surgery 6) ECOG score = 2 points 7) Blood picture, liver and kidney function are within the following allowable range (tested 7 days before the start of treatment): white blood cell (WBC) =3.0×10 ^ 9 / L or neutrophil (ANC) = 1.5×10 ^ 9 / L; Hemoglobin (HGB) = 80g / L; Platelets (PLT) = 100×10 ^ 9 / L; Liver transaminase (AST, ALT) <5.0 times the upper limit of the normal range; Total bilirubin (TBIL) <Normal range 2 times the upper limit; CREAT <1.5 times the upper limit of the normal range 8) Patients of childbearing age must take effective birth control measures

Exclusion criteria

Exclusion criteria: 1) Heart, lung, liver, kidney, hematopoietic function and abnormal reserve function are abnormal, and cannot tolerate surgical treatment and chemotherapy 2) The patient has cognitive impairment or is unable to adhere to long-term follow-up 3) History of other malignant tumors in the past 5 years 4) Pregnant or lactating women 5) Drug abuse, drug abuse, long-term alcohol addiction and sufferers

Design outcomes

Primary

MeasureTime frame
full exon sequencing;

Countries

China

Contacts

Public ContactChengjing
Chenjin1118@hotmail.com13006178752

Outcome results

None listed

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