Carboplatin Intensified Chemotherapy for TRIple NEgative Breast Cancer(CITRINE)

Last updated: March 25, 2025
Sponsor: Fudan University
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Carboplatin

Paclitaxel(with carbo)

Paclitaxel

Clinical Study ID

NCT04296175
1807187-2
  • Ages 18-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 marrowfunction: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absoluteneutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 75 * 109 /L; (2)adequate liver andkidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN),Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serumcreatinine ≤ 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 participateand to be followed up

  7. For women of childbearing potential: agreement to remain abstinent (refrain fromheterosexual intercourse) or use contraceptive measures as outlined for eachspecific treatment arm

Exclusion

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 adequatelytreated 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 cannotpractice effective contraceptives;

  6. Patients participating in other clinical trials at the same time;

  7. Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, leftventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardiocerebral vascular disease within the 6 months previous of randomization (such asunstable angina, chronic heart failure, uncontrolled hypertension with bloodpressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabeticpatients 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 drughabits, or those with history of mental disorders;

  11. the researchers judged patients to be unsuitable for the study.

Study Design

Total Participants: 808
Treatment Group(s): 7
Primary Treatment: Carboplatin
Phase: 3
Study Start date:
March 05, 2020
Estimated Completion Date:
March 31, 2027

Study 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.

Connect with a study center

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200032
    China

    Site Not Available

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