Phase
Condition
N/ATreatment
Carboplatin
Paclitaxel(with carbo)
Paclitaxel
Clinical Study ID
Ages 18-70 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Histologically documented TNBC after early breast cancer surgery (absence of HER2,ER, and PR expression)
Has adequate organ function meeting the following criteria: (1) adequate bone marrowfunction: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absoluteneutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 75 * 109 /L; (2)adequate liver andkidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN),Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serumcreatinine ≤ 1×ULN#and with endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula).
Women aged 18-70 years old;
Lymph nodes positive or lymph nodes negative but with ki67 no less than 50%
Have the cognitive ability to understand the protocol and be willing to participateand to be followed up
For women of childbearing potential: agreement to remain abstinent (refrain fromheterosexual intercourse) or use contraceptive measures as outlined for eachspecific treatment arm
Exclusion
Exclusion Criteria:
Has received neoadjuvant therapy (include chemotherapy, targeted therapy,radiotherapy or endocrine therapy;
Has bilateral breast cancer;
Has previous history of additional malignancy, with the exception of adequatelytreated basal cell carcinoma and cervical carcinoma in situ.
Has metastatic breast cancer
Is pregnant, is breast feeding women, or women of childbearing age who cannotpractice effective contraceptives;
Patients participating in other clinical trials at the same time;
Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, leftventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardiocerebral vascular disease within the 6 months previous of randomization (such asunstable angina, chronic heart failure, uncontrolled hypertension with bloodpressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabeticpatients with poor blood glucose control; patients with severe hypertension;
Has known allergy to taxane
Has severe or uncontrolled infection;
Has a history of psychotropic substance abuse and were unable to abandon drughabits, or those with history of mental disorders;
the researchers judged patients to be unsuitable for the study.
Study Design
Study Description
Connect with a study center
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200032
ChinaSite Not Available
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