Phase
Condition
Breast Cancer
Cancer
Treatment
N/AClinical Study ID
Ages 18-70 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 largerthan 2 cm.
Blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgerycan 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 toone;
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'ssyndrome ≤ 2.5 × ULN;
Patients had good compliance with the planned treatment, understood the researchprocess and written informed consent.
Exclusion
Exclusion Criteria:
Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy orradiotherapy;
Patients with heart disease above grade II (including grade II) identified by New YorkHeart 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 cervicalcarcinoma in situ and non-melanoma skin cancer;
Pregnancy or lactation, as well as reproductive age patients who refused to takeappropriate contraceptive measures in the trial;
Participation in any trial drug treatment or another interventional clinical trial 30days before first dose was given;
The researchers considered the patients who were not suitable for enrollment.
Study Design
Connect with a study center
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei 050011
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.