Carboplatin Intensified Chemotherapy for TRIple NEgative Breast Cancer(CITRINE) (CITRINE)

STATUS

Recruiting
End date

Jun 23, 2025
participants needed

808
sponsor

Fudan University

Send

Updated on 28 February 2022

See if I qualify

platelet count

paclitaxel

cancer

breast cancer

carboplatin

HER2

blood transfusion

triple negative breast cancer

erbb2

epirubicin

ki-67

Summary

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.

Details

Condition	Triple-negative Breast Cancer
Treatment	carboplatin, Epirubicin, Paclitaxel, CTX, ddEpirubicin, ddCTX, Paclitaxel(with carbo)
Clinical Study Identifier	NCT04296175
Sponsor	Fudan University
Last Modified on	28 February 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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) 3upper limit of normal (ULN), Aspartate Aminotransferase (AST) 3ULN, Total Bilirubin (TBIL) 1.5ULN, serum creatinine 1ULN#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
Exclusion Criteria
	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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

triple negative breast cancer

erbb2

epirubicin

ki-67

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Edit Delete

Added by •

•

Private

Edit Delete

Reply by • • Private

Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

Enter the passcode

The passcode will expire in None.

Carboplatin Intensified Chemotherapy for TRIple NEgative Breast Cancer(CITRINE) (CITRINE)