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Carboplatin Intensified Chemotherapy for TRIple NEgative Breast Cancer(CITRINE)

NCT04296175 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 808

Last updated 2025-03-26

No results posted yet for this 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.

Conditions

  • Triple-negative Breast Cancer

Interventions

DRUG

Epirubicin

90mg/m2, d1 every 2 or 3 weeks

DRUG

CTX

600mg, d1 every 2 or 3 weeks

DRUG

Paclitaxel

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

DRUG

ddEpirubicin

90mg/m2, d1 every 2 weeks

DRUG

ddCTX

600mg, d1 every 2 weeks

DRUG

Paclitaxel(with carbo)

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

DRUG

Carboplatin

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhimin Shao, Professor · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-05
Primary Completion
2025-03-10
Completion
2027-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04296175 on ClinicalTrials.gov