Carboplatin Intensified Chemotherapy for TRIple NEgative Breast Cancer(CITRINE)

  • STATUS
    Recruiting
  • End date
    Jun 23, 2025
  • participants needed
    808
  • sponsor
    Fudan University
Updated on 23 January 2021
platelet count
paclitaxel
cancer
breast cancer
carboplatin
HER2
blood transfusion
triple negative breast cancer
erbb2
epirubicin
ki-67

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.

Description

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.High risk is defined as positive lymph nodes or negative lymph nodes but ki-67 is not less than 50%. We aim to explore whether the addition of carboplatin can improve the disease-free survival of early high-risk triple-negative breast cancer. At the same time, the experimental group's anthracyclines must be given in a dose-dense manner, while anthracyclines in the control group are dose-dense or not.

Details
Condition Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer
Treatment carboplatin, Epirubicin, Paclitaxel, CTX, ddEpirubicin, ddCTX, Paclitaxel(with carbo)
Clinical Study IdentifierNCT04296175
SponsorFudan University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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) 3upper limit of normal (ULN), Aspartate Aminotransferase (AST) 3ULN, Total Bilirubin (TBIL) 1.5ULN, serum creatinine 1ULN#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
Has metastatic breast cancer
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
Has known allergy to taxane
Has severe or uncontrolled infection
Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders
the researchers judged patients to be unsuitable for the study
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