Carboplatin Intensified Chemotherapy for TRIple NEgative Breast Cancer(CITRINE) (NCT04296175) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Carboplatin Intensified Chemotherapy for TRIple NEgative Breast Cancer(CITRINE)
China808 participantsStarted 2020-03-05
Plain-language summary
This is a prospective, single center, randomized, open-labled stage III clinical trial comparing the efficacy and safety of anthracyclin followed by weekly paclitaxel versus dose-dense anthracyclin followed by weekly paclitaxel versus dose-dense anthracyclin followed by weekly paclitaxel combined with carboplatin for high-risk, triple-negative early breast cancer.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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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 marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 75 \* 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 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 participate and to be followed up
✓. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm
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 adequately treated basal cell carcinoma and cervical carcinoma in situ.
✕. Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
✕. Patients participating in other clinical trials at the same time;
✕. Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \< 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;