Status:
RECRUITING
Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer
Lead Sponsor:
Hebei Medical University Fourth Hospital
Collaborating Sponsors:
Beijing 302 Hospital
CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions:
Breast Cancer
Triple-negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
This is a multicenter, open, randomized, comparison study. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (ER) and the...
Eligibility Criteria
Inclusion
- Females with age between 18 to 70 years old;
- Histologically confirmed primary invasive breast cancer;
- Histologically confirmed triple negative breast cancer;
- Patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm.
- Blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgery can be obtained.
- Have at least one measurable lesion as per the RECIST criteria (version 1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
- LVEF≥55%；
- Bone marrow function：neutrophils (≥1.5×10\^9/L), platelets (≥100×10\^9/L), hemoglobin (≥90 g/L);
- Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;
- Patients had good compliance with the planned treatment, understood the research process and written informed consent.
Exclusion
- Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy;
- Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
- Patients with severe systemic infection or other serious diseases;
- Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;
- Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
- Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;
- Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;
- The researchers considered the patients who were not suitable for enrollment.
Key Trial Info
Start Date :
November 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2028
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT04138719
Start Date
November 20 2019
End Date
June 20 2028
Last Update
September 11 2025
Active Locations (1)
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1
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011