Carboplatin Intensified Chemotherapy for TRIple NEgative Breast Cancer(CITRINE)

Conditions

Triple-negative Breast Cancer

Keywords

dose-dense chemotherapy, Carboplatin, High-risk, Triple-negative Early Breast Cancer

Brief 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.

Detailed 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.

Y. Liu, Y. Gong, X. Zhu, G. Liu, K. Yu et al. (19 authors)

Clinical Cancer Research2026-02-17

10.1158/1557-3265.sabcs25-rf2-04

Effect of adjuvant carboplatin intensified chemotherapy versus standard chemotherapy on survival in women with high risk, early stage, triple negative breast cancer (CITRINE): randomised, open label phase 3 trial.

Liu Y, Gong Y, Zhu XZ, Liu GY, Yu KD, Yang F, Chen L, He M, Hu Z, Chen CM, Cao AY, Li JJ, Hou YF, Di GH, Wu J, Jiang YZ, Fan L, Wang ZH, Shao ZM.

2025-12-23

10.1136/bmj-2025-085457

Intensive chemotherapy versus standard chemotherapy among patients with high risk, operable, triple negative breast cancer based on integrated mRNA-lncRNA signature (BCTOP-T-A01): randomised, multicentre, phase 3 trial

Min He, Yizhou Jiang, Yue Gong, Lei Fan, Xiyu Liu et al. (22 authors)

BMJ2024-10-2314 citations

10.1136/bmj-2024-079603

Interventions

DRUGEpirubicin

90mg/m2, d1 every 2 or 3 weeks

DRUGCTX

600mg, d1 every 2 or 3 weeks

DRUGPaclitaxel

80mg/m2,d1,d8,d15, every 3 weeks

DRUGddEpirubicin

90mg/m2, d1 every 2 weeks

DRUGddCTX

600mg, d1 every 2 weeks

DRUGPaclitaxel(with carbo)

80mg/m2,d1,d8,d15, every 4 weeks

DRUGCarboplatin

AUC=2,d1,d8,d15, every 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

1:1 randomized controlled trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

No

Inclusion criteria

1. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 2. Histologically documented TNBC after early breast cancer surgery (absence of HER2, ER, and PR expression) 3. 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). 4. Women aged 18-70 years old; 5. Lymph nodes positive or lymph nodes negative but with ki67 no less than 50% 6. Have the cognitive ability to understand the protocol and be willing to participate and to be followed up 7. 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

1. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy; 2. Has bilateral breast cancer; 3. Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ. 4. Has metastatic breast cancer 5. Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives; 6. Patients participating in other clinical trials at the same time; 7. 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; 8. Has known allergy to taxane 9. Has severe or uncontrolled infection; 10. Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders; 11. the researchers judged patients to be unsuitable for the study.

Design outcomes

Primary

Measure	Time frame
Disease free survival	3 year

Secondary

Measure	Time frame
overall survival	3 year
distant disease free survival	3 year
recurrence free survival	3 year
Disease free survival	5 year

Countries

China

Outcome results

None listed