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PERS Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer

Using PERS(PErsonalized Regimen Selection) Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer Multicentric, Prospective, Randomized Controlled Phase III Clinical Study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015415
Enrollment
Unknown
Registered
2018-04-15
Start date
2016-04-01
Completion date
Unknown
Last updated
2018-05-21

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

Conditions

breast cancer

Interventions

Case series:PERS Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Aged at least 18 years old; 1. ECOG(Eastern Cooperative Oncology Group) scoring =1; 2. confirmed by histology or cytology breast infiltrating ductal carcinoma; 3. agreed to breast cancer tissue biopsy; 4. here is a new adjuvant chemotherapy against patients with stage II/III; 5. According to RECIST criteria, target lesion in patients with at least one, at least one single diameter measurable lesions. Has been defined as a measurable lesions with the following method can accurately measure at least one of the diameter of the lesion: lesions or greater diameter 20 mm or measured in conventional methods spiral CT measurement lesions 10 mm diameter or greater. Positron emission tomography (CT) and ultrasound can not be used as measurement method lesions; 6. The normal numerical laboratory The patient's level of organ function must meet the following requirements: enough reserves: bone marrow neutrophils (cent leaves and ribbon neutrophils) absolute count (ANC) =1.5*10^9/L, or platelets= 100*10^9/L, or acuity = 9 g/dL and hemoglobin.Liver: bilirubin < 1.5 times the upper limit of normal, alkaline phosphatase (AP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 times the upper limit of normal (If allowed to AP with liver metastasis, AST, ALT < 5 times the upper limit of normal). Kidney creatinine clearance or 45 mL/min; 7. Signed informed consent; 8. Expected to survival in patients with 3 or more months; 9. patient adherence and geographic location of residence meet the needs of the follow-up; 10. in the research into the group of 7 days before the serum or urine pregnancy test must be negative, and must be for the nursing of patients. Or sterilization surgery, patients after menopause, or agreed to in the research during the treatment and research within 6 months after the end of the treatment period using an approved by the medical contraception (such as intrauterine device (IUD), pill or condoms).

Exclusion criteria

Exclusion criteria: ECOG(Eastern Cooperative Oncology Group) scoring =2; 1. At the same time to accept any other anti-tumor treatment; 2. In the past 12 months have congestive heart failure, drug treatment can't control history of arrhythmia, myocardial infarction, etc; 3. The serious, which has not been controlled intercurrent infection, organ dysfunction, or serious metabolic disorder of patients; 4. Active infection (decided by the researchers; 5. According to the researcher's judgment, there is serious to endanger the safety of patients, or patients completed the research associated with disease; 6. Pregnancy or breast-feeding women; 7. Always have a clear history of neurological or psychiatric disorders, including epilepsy, or dementia; 8. A history of other tumors or combined with other tumor patients; 9. Before study enrollment for any reason within 30 days of use had not been approved by the local drug 10. Unwilling or unable to continue to comply with the experimental program, or can not cope with patients follow-up; 11. Researchers think that is unfavorable to the participant.

Design outcomes

Primary

MeasureTime frame
pCR (pathologic complete response);

Secondary

MeasureTime frame
DFS(Disease-free survival);

Countries

China

Contacts

Public ContactShi Yanxia

Sun Yat-sen University Cancer Center

shiyx@sysucc.org.cn+86 13609058827

Outcome results

None listed

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