Carboplatin Intensified Chemotherapy for TRIple NEgative Breast Cancer(CITRINE)

Triple-negative Breast Cancer Clinical Trial

— CITRINE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04296175
• Other study ID #: 1807187-2
• Status: Recruiting
• Phase: Phase 3
• Start date: March 5, 2020
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Fudan University
• Contact: Zhimin Shao, Professor
• Phone: 08664175590
• Email: zhimingshao[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 808
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Neoplasms
• Triple-negative Breast Cancer

Intervention

Drug:
• Epirubicin
90mg/m2, d1 every 2 or 3 weeks
• CTX
600mg, d1 every 2 or 3 weeks
• Paclitaxel
80mg/m2,d1,d8,d15, every 3 weeks
• ddEpirubicin
90mg/m2, d1 every 2 weeks
• ddCTX
600mg, d1 every 2 weeks
• Paclitaxel(with carbo)
80mg/m2,d1,d8,d15, every 4 weeks
• Carboplatin
AUC=2,d1,d8,d15, every 4 weeks

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		3 year
Secondary	overall survival		3 year
Secondary	distant disease free survival		3 year
Secondary	recurrence free survival		3 year
Secondary	Disease free survival		5 year
Secondary	overall survival		5 year
Secondary	recurrence free survival		5 year
Secondary	distant disease free survival		5 year