Carboplatin Intensified Chemotherapy for TRIple NEgative Breast Cancer(CITRINE)

NCT ID: NCT04296175

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 808 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-05
• Study Completion Date: 2027-03-31

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.

Conditions

Triple-negative Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

conventional group

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.

Group Type: ACTIVE_COMPARATOR

Epirubicin

Intervention Type: DRUG

90mg/m2, d1 every 2 or 3 weeks

CTX

Intervention Type: DRUG

600mg, d1 every 2 or 3 weeks

Paclitaxel

Intervention Type: DRUG

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

carboplatin group

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.

Group Type: EXPERIMENTAL

ddEpirubicin

Intervention Type: DRUG

90mg/m2, d1 every 2 weeks

ddCTX

Intervention Type: DRUG

600mg, d1 every 2 weeks

Paclitaxel(with carbo)

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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

Interventions

Epirubicin

90mg/m2, d1 every 2 or 3 weeks

Intervention Type: DRUG

CTX

600mg, d1 every 2 or 3 weeks

Intervention Type: DRUG

Paclitaxel

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

Intervention Type: DRUG

ddEpirubicin

90mg/m2, d1 every 2 weeks

Intervention Type: DRUG

ddCTX

600mg, d1 every 2 weeks

Intervention Type: DRUG

Paclitaxel(with carbo)

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

Intervention Type: DRUG

Carboplatin

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Shao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhimin Shao, Professor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

1807187-2

Identifier Type: -

Identifier Source: org_study_id