Bone Marrow Suppression, Breast Cancer
Conditions
Brief summary
The subjects were randomly assigned to Group A or Group B in a 1:1 ratio, stratified by early/late stage. Group A: In the first cycle, they took Shengbai Oral Liquid (40 ml, three times a day), and in the second cycle, they took Leucogen Tablets (20 mg, three times a day). Group B: In the first cycle, they took Leucogen Tablets (20 mg, three times a day), and in the second cycle, they took Shengbai Oral Liquid (40 ml, three times a day).
Interventions
DRUGGroup A
In the first cycle, they took Shengbai Oral Liquid (40 ml, three times a day), and in the second cycle, they took Leucogen Tablets (20 mg, three times a day).
DRUGGroup B
In the first cycle, they took Leucogen Tablets (20 mg, three times a day), and in the second cycle, they took Shengbai Oral Liquid (40 ml, three times a day).
Sponsors
Hongxia Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age range: 18 to 80 years old, gender unrestricted; 2. Patients with breast cancer confirmed by histopathology. 3. ECOG performance status score ≤ 2; expected survival time ≥ 12 weeks; 4. During the period of anti-tumor drug treatment before enrollment (including but not limited to chemotherapy drugs: paclitaxel, capecitabine, vinorelbine; CDK4/6 inhibitors: palbociclib, dalpiciclib, ribociclib, abemaciclib; antibody-drug conjugates: trastuzumab emtansine, trastuzumab deruxtecan, sacituzumab govitecan, larotrectinib), grade II-III neutropenia occurred, and it is planned to continue the original treatment plan and dose for at least 2 cycles. 5. The subject meets the criteria for continuing anti-tumor drug treatment; normal bone marrow hematopoietic function, no bleeding tendency (INR \< 1.5); blood routine meets the following requirements: Hb ≥ 8g/dl, platelet count ≥ 75×109/L; liver and kidney function meets the following requirements: AST and ALT ≤ 3 ULN, total bilirubin ≤ 2 ULN, serum creatinine ≤ 1.5 ULN; no obvious heart and lung function disorders; 6. The subject has high compliance and voluntarily signs the informed consent form.
Exclusion criteria
* 1\. Having participated in other new drug clinical trials within 4 weeks before enrollment; planning to participate in other new drug clinical trials during the study period; planning to add other anti-tumor treatments during the study period; 2. Having received bone marrow radiotherapy involving 25% of the bone marrow; having undergone hematopoietic stem cell transplantation or bone marrow transplantation; 3. Uncontrolled acute or chronic infection; having severe underlying diseases such as heart, lung, liver or kidney diseases; having primary diseases of the hematopoietic system; having diseases such as hypersplenism, hyperthyroidism, adrenal insufficiency, connective tissue diseases, etc. that can cause a decrease in white blood cells; 4. Uncontrolled digestive system symptoms that affect the administration of the study drug; confirmed or suspected allergy to the study drug or its related components; 5. Uncontrolled psychological or mental disorders; judged by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lowest neutrophil count (ANC) in the two stages | From the initial treatment to the end of follow-up, approximately 42 or 56 days | Compare the lowest values of neutrophils (ANC) in each group during the two chemotherapy cycles |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of ANC decline (Grade II/III/IV), duration of ANC decline in the two stages | From the initial treatment to the end of follow-up, approximately 42 or 56 days | Compare the decline rates of grade II /III /IV ANC and the duration of ANC decline in each group during two chemotherapy cycles |
| Dosage of G-CSF | From the initial treatment to the end of follow-up, approximately 42 or 56 days | Compare the dosage of G-SCF in each group during the two chemotherapy cycles |
| The incidence of febrile neutropenia | From the initial treatment to the end of follow-up, approximately 42 or 56 days | Compare the incidence of febrile neutropenia in each group during two chemotherapy cycles |
| Infection incidence rate | From the initial treatment to the end of follow-up, approximately 42 or 56 days | Compare the incidence of infection in each group during the two chemotherapy cycles |
| Antibiotic utilization rate | From the initial treatment to the end of follow-up, approximately 42 or 56 days | Compare the utilization rate of antibiotics in each group during the two chemotherapy cycles |
| The completion rate of anti-tumor drugs | From the initial treatment to the end of follow-up, approximately 42 or 56 days | Compare the completion rates of anti-tumor drugs in each group during the two chemotherapy cycles |
Countries
China
Contacts
CONTACTHongxia wang, PhD
Outcome results
None listed