breast cancer
Conditions
Interventions
Test group:utiderone plus capecitabine
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Sign the informed consent form; Patients must be =18 years old female; Inoperable local advanced breast cancer patients (T2-3N2-3M0, T4 any N M0); HER2 negative breast cancer confirmed by the pathology at the research center; A regimen receiving at least two cycles of anthracycline combined with taxane was assessed by tumor imaging as SD or PD; The patient's ECOG physical fitness status score must be 0 or 1; All toxicities related to previous antitumor drug treatment must be restored to grade 1 (CTCAE v5.0), except for those no safety risk such as lipsotrichia etc.; Pregnancy test (urine or serum) was negative; Patients must be able to participate in and comply with the treatment and following up.
Exclusion criteria
Exclusion criteria: Primary stage IV breast cancer; Inflammatory breast cancer; History of the other malignancies except: cervix cancer in situ, colon cancer in situ, melanoma in situ, skin basal cell carcinoma and squamous cell carcinoma; Bilateral primary breast cancer (infiltrative or DCIS); Any sex hormone therapy, such as contraceptive pills, ovarian hormone replacement therapy (these patients can participate in the study if it is stopped before enrollment); Any hormone medication (e. g., raloxifen, tamoxifen, or other selective estrogen receptor modulators) for osteoporosis or breast cancer prophylaxis (only patients who have discontinued these drugs before enrollment can participate in the study); Grade 3 or above neurological-related adverse events in previous chemotherapy; Having undergone a major surgical operation unrelated to breast cancer within 4 weeks before enrollment or the patient has not fully recovered; Pre-entry examination shows any of the following abnormal laboratory examination results: Total bilirubin> 1.5 Normal upper limit (ULN), or for known cases of Gilbert syndrome, total bilirubin> 2 ULN AST and / or ALT> 1.25 ULN, and alkaline phosphatase> 2.5 ULN Serum creatinine> 1.5 ULN Total WBC counts were <2,500 cells / µ L Absolute neutrophil count was <1500 cells / µ L Platelet count was <100,000 cells / µ L Excluding any other non-malignant systemic diseases (cardiovascular, kidney, liver, etc.) that hinder treatment or follow-up; Known or suspected allergy to any study drug or excipients; Unable to take or absorb oral drugs; Prohibition of using corticosteroids; Any other conditions that the investigator considering unfit to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinicle response rate;events free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety and tolerability;operable rate;pathological complete response rate; | — |
Countries
China
Contacts
Public ContactQianjun Chen
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed