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Triple-negative Breast CancerPhase 3CITRINENCT04296175

Carboplatin Intensified Chemotherapy for TRIple NEgative Breast Cancer(CITRINE)

A Phase 3 study testing Epirubicin, CTX and Paclitaxel in people with Triple-negative Breast Cancer, run by Fudan University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Triple-negative Breast Cancer
What is being tested?
Epirubicin, CTX and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
808 participants
Where
1 siteChina
Study dates
5 Mar 2020to Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Epirubicin, CTX, Paclitaxel, ddEpirubicin, ddCTX
Keywords
dose-dense chemotherapy, Carboplatin, High-risk, Triple-negative Early Breast Cancer
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EpirubicinDrug

    90mg/m2, d1 every 2 or 3 weeks

  • CTXDrug

    600mg, d1 every 2 or 3 weeks

  • PaclitaxelDrug

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

  • ddEpirubicinDrug

    90mg/m2, d1 every 2 weeks

  • ddCTXDrug

    600mg, d1 every 2 weeks

  • Paclitaxel(with carbo)Drug

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

  • CarboplatinDrug

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

Study groups in NCT04296175
Study groupRoleWhat they receive
conventional groupActive comparatorepirubincin 90mg/m2 d1 and CTX 600mg/m2 d1, every 2 or 3 weeks followed by paclitaxel 80mg/m2 d1,d8,d15, every 3 weeks.
Receives: Drug: Epirubicin; Drug: CTX; Drug: Paclitaxel
carboplatin groupExperimentalepirubincin 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.
Receives: Drug: ddEpirubicin; Drug: ddCTX; Drug: Paclitaxel(with carbo); Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease free survival

    Measured: 3 year

Secondary outcomes (7)

  1. overall survival

    Measured: 3 year

  2. distant disease free survival

    Measured: 3 year

  3. recurrence free survival

    Measured: 3 year

  4. Disease free survival

    Measured: 5 year

  5. overall survival

    Measured: 5 year

  6. recurrence free survival

    Measured: 5 year

  7. distant disease free survival

    Measured: 5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2020
  2. Study start5 Mar 2020
  3. Primary completion10 Mar 2025
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 randomized controlled trial
Masking
None (open label)
Enrolment
808 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04296175
Sponsor's protocol ID
1807187-2
Acronym
CITRINE
Status last verified
Mar 2025
First submitted
3 Mar 2020
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41436191

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epirubicin, CTX and Paclitaxel in people with Triple-negative Breast Cancer, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival (time frame: 3 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04296175, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.

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