Breast cancer
Conditions
Interventions
AC591 experimental group:AC591 granules
AC591 control group:AC591 simulator granules
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: (1) Pathological confirmed breast cancer; (2) Female with age between 18 to 70 years old; (3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and the subsequent treatment is assessed to be tolerant; (4) Have not received the paclitaxel-containing chemotherapy regimens before; (5) Understand the clinical study procedures and content, voluntarily participate in the study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up; (6) Expected survival period over 12 months; (7) The level of organ function before the first medication of the study meets the following requirements: ? Peripheral blood count: white blood cell count =3×109/L and neutrophils =1.5×109/L, platelet count =75×109/L, hemoglobin =90g/L; ? Liver function: total bilirubin = 1.5 times the upper limit of the normal reference value; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 times the upper limit of the normal reference value; subjects with liver metastases, AST and ALT = 5 times the upper limit of the normal reference value; ? Renal function: serum creatinine = 1.5 times the upper limit of the normal reference value.
Exclusion criteria
Exclusion criteria: (1) Patients with severe cardiovascular and cerebrovascular, neurological, or mental diseases; (2) Female patients who are pregnant or breastfeeding, female patients who are fertile and have a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire clinical trial; (3) Unable to swallow, chronic diarrhea, and intestinal obstruction, exist many factors affect drug taking and absorption; (4) The research drug of other clinical trials has been used four weeks before enrollment; (5) Receive any anti-tumor treatment for other tumors at the same time; (6) Have an allergic reaction to any component of the study drug; (7) According to the investigator’s judgment, there are concomitant diseases that seriously affect the patient’s safety or affect the patient’s completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, brain and/or pia mater metastases, severe lung disease); (8) Active severe clinical infection (National Cancer Institute-Common Adverse Event Evaluation Criteria [NCI-CTCAE] Version 5.0 that assessed >grade 2), including active tuberculosis; (9) Renal replacement therapy; (10) Previous history of organ transplantation, autologous/allogeneic stem cell transplantation; (11) HIV infection, hepatitis B surface antigen positive (and peripheral blood hepatitis B virus deoxynucleotide HBV DNA = 1×104 copy number/mL or = 2000IU/mL), hepatitis C virus antibody positive (and peripheral blood hepatitis C virus nucleoside HCV RNA=1×103 copy number/ml or =200IU/mL); (12) The adverse events of previous treatment (except hair loss) have not recovered to grade 1 or below (NCI-CTCAE version 5.0); (13) Other situations that the investigator believes that the patient is not suitable for participating in this study; (14) Current alcohol or drug dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of neuropathy; | — |
Secondary
| Measure | Time frame |
|---|---|
| EORTC-QLQ-CIPN 20 score;EORTC QLQ-C30 score;Muscle function grade score during chemotherapy;Cognitive ability rating during chemotherapy; | — |
Countries
China
Contacts
Public ContactQianjun Chen
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed