Non-Inferiority Study on MRNA-lncRNA Model in Low-Risk Triple-Negative Breast Cancer Patients

Phase 3

Not yet recruiting

• Conditions: Triple-negative Breast Cancer
• Interventions: Drug: Docetaxel plus cyclophosphamide; Drug: Epirubicin, cyclophosphamide plus paclitaxel

• Registration Number: NCT06795503
• Lead Sponsor: Fudan University

Brief Summary

To compare the efficacy and safety of different adjuvant chemotherapy regimens for low-risk triple-negative breast cancer patients predicted by mRNA-lncRNA model

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-04
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28
• Study Start: 2025-02
• Primary Completion: 2028-08
• Study Completion: 2031-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1462

Inclusion Criteria

1. Female participants aged ≥18 and ≤70 years.
2. ECOG performance status of 0 to 1.
3. Histologically confirmed invasive triple-negative breast cancer (TNBC), defined as breast cancer with estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) all determined to be negative by pathological testing. Specifically, ER-negative: IHC <1%, PR-negative: IHC <1%, HER2-negative: IHC -/+ or IHC++ but FISH/CISH negative. Tissue samples must be verified by the central lead institution as low-risk according to the mRNA-lncRNA model.
4. Postoperative early-stage breast cancer patients who have undergone radical surgery, with pathological TNM staging of pT1c-3N0-3M0.
5. Normal major organ function, meeting the following criteria: ① Hematological examination standards: HB ≥ 90g/L (no blood transfusion within the last 14 days); ANC ≥ 1.5×10⁹/L; PLT ≥ 75×10⁹/L; ② Biochemical examination standards: TBIL ≤ 1.5×ULN (upper limit of normal); ALT and AST ≤ 3×ULN; Serum Cr ≤ 1×ULN, and creatinine clearance rate > 50ml/min (Cockcroft-Gault formula).
6. Women of childbearing potential must use medically approved contraception during the study treatment period and for at least 3 months after the last dose of the study drug.
7. Participants must voluntarily join the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up procedures.

Exclusion Criteria

1. Patients who have received neoadjuvant treatment, including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy.
2. Bilateral breast cancer.
3. Metastasis at any site.
4. Any >T4 lesions (UICC1987) (involving skin invasion, tumor fixation, or inflammatory breast cancer).
5. History of clinically significant or uncontrolled heart disease, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmias.
6. History of other malignancies within the past 5 years, except for cured in situ cervical cancer, basal cell carcinoma, or squamous cell carcinoma of the skin.
7. Pregnant or breastfeeding women, or women of childbearing potential who are unable to use effective contraception.
8. Patients concurrently participating in other clinical trials.
9. Severe or uncontrolled infections.
10. Known active HBV or HCV infection, or HBV DNA ≥ 500, or chronic infection with abnormal liver function.
11. History of substance abuse that cannot be quit or any psychiatric disorders.
12. Patients deemed unsuitable for the study by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Docetaxel plus cyclophosphamide	Docetaxel plus cyclophosphamide
Control group	Epirubicin, cyclophosphamide plus paclitaxel	Epirubicin, cyclophosphamide followed by paclitaxel

Primary Outcome Measures

Name	Time	Method
invasive disease-free survival (iDFS)	Five years	Invasive disease-free survival (iDFS) is the time after initial cancer treatment during which a patient remains free from invasive cancer recurrence. It's an important measure in clinical trials to assess how well treatments prevent the return of cancer or the development of new invasive cancers after the primary treatment has been completed.

Secondary Outcome Measures

Name	Time	Method
Distant recurrence-free survival (DRFS)	Five years	Distant recurrence-free survival (DRFS): This refers to the length of time after primary cancer treatment during which a patient does not experience cancer recurrence in distant organs or sites. DRFS is commonly used to evaluate the effectiveness of treatments in preventing metastasis or the spread of cancer to distant parts of the body.
Overall survival (OS)	Five years	Overall survival (OS): OS is the time from the start of treatment or diagnosis until death from any cause. It is the most direct and important endpoint in clinical trials, measuring the effectiveness of a treatment in extending a patient's life.
Safety according to CTCAE v5.0 (Common Terminology Criteria for Adverse Events, version 5.0)	Five years	Safety according to CTCAE v5.0: This refers to the assessment of adverse events or side effects of treatment based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. It provides a standardized way to evaluate and report the severity and frequency of treatment-related toxicities to ensure patient safety.