Status:
UNKNOWN
AC vs TC in Patients With HR-positive, HER2-negative Early Breast Cancer
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Breast Cancer
Chemotherapeutic Toxicity
Eligibility:
FEMALE
18-70 years
Phase:
PHASE4
Brief Summary
Anthracycline-paclitaxel sequential combination therapy is the standard regimen for perioperative chemotherapy in breast cancer. The strategy of perioperative chemotherapy is based on breast cancer su...
Detailed Description
At present, the liposomal doxorubicin developed on the basis of doxorubicin has been used for the first-line treatment of advanced breast cancer, and both NCCN and CSCO guidelines have related recomme...
Eligibility Criteria
Inclusion
- Age: 18\~70 years old, female;
- Patients with primary breast cancer diagnosed by histopathology and clinical stage of T1b-2 N0;
- The expression of HER-2 is negative by immunohistochemistry (IHC). If the expression of HER-2 is 2+, in situ hybridization is required to confirm that the HER-2 gene is not amplified; HR+.
- ECOG physical fitness score 0-1 points;
- LVEF≥55%;
- Bone marrow function: neutrophils≥1.5×109/L, platelets≥100×109/L, hemoglobin≥90g/L;
- Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal; AST and ALT ≤2.5 times the upper limit of normal; total bilirubin ≤1.5 times the upper limit of normal, or ≤2.5 times the upper limit of normal when the patient has Gilbert's syndrome ;
- The patient has good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent.
Exclusion
- Received cytotoxic chemotherapy, endocrine therapy, biological therapy or radiation therapy for any reason;
- New York Heart Association (NYHA) score identifies patients with heart disease of grade II or above (including grade II);
- Patients with severe systemic infection or other serious diseases;
- Patients who are known to be allergic or intolerant to chemotherapy drugs or their excipients;
- Other malignant tumors have occurred in the past 5 years, except for skin cancer of cured cervical carcinoma in situ and non-melanoma;
- Patients of childbearing age who are pregnant or breastfeeding and who refuse to take appropriate contraceptive measures during this trial;
- Participated in other experimental studies within 30 days before the administration of the first dose of the investigational drug;
- Patients judged by the investigator to be inappropriate to participate in this study.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT05302336
Start Date
May 1 2022
End Date
December 30 2024
Last Update
April 14 2022
Active Locations (1)
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1
Second Affiliated Hospital, School of Medicine, Zhejiang University, China
Hanzhou, Zhejing, China, 310000