Carboplatin Intensified Chemotherapy for TRIple NEgative Breast Cancer(CITRINE)

NCT04296175 | Active Not Recruiting Phase 3

• 1 other identifier: 1807187-2
• Study Type: interventional
• Target: 808
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple-negative Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  3 year

Secondary Outcomes (7)

• overall survival

  3 year

• distant disease free survival

  3 year

• recurrence free survival

  3 year

• Disease free survival

  5 year

• overall survival

  5 year

Study Arms (2)

conventional group

ACTIVE COMPARATOR

epirubincin 90mg/m2 d1 and CTX 600mg/m2 d1, every 2 or 3 weeks followed by paclitaxel 80mg/m2 d1,d8,d15, every 3 weeks.

Drug: Epirubicin; Drug: CTX; Drug: Paclitaxel

carboplatin group

EXPERIMENTAL

epirubincin 90mg/m2 d1 and CTX 600mg/m2 d1, every 2 weeks followed by paclitaxel 80mg/m2 and carboplatin AUC=2 d1,d8,d15, every 4 weeks.

Drug: ddEpirubicin; Drug: ddCTX; Drug: Paclitaxel(with carbo); Drug: Carboplatin

Interventions

Epirubicin DRUG

90mg/m2, d1 every 2 or 3 weeks

conventional group

CTX DRUG

600mg, d1 every 2 or 3 weeks

conventional group

Paclitaxel DRUG

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

conventional group

ddEpirubicin DRUG

90mg/m2, d1 every 2 weeks

carboplatin group

ddCTX DRUG

600mg, d1 every 2 weeks

carboplatin group

Paclitaxel(with carbo) DRUG

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

carboplatin group

Carboplatin DRUG

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

carboplatin group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• 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. 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. BMJ. 2025 Dec 23;391:e085457. doi: 10.1136/bmj-2025-085457.

  PMID: 41436191 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Epirubicin; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Zhimin Shao, Professor

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1:1 randomized controlled trial

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: March 5, 2020
• Primary Completion: March 10, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

CN (1)