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

Fudan University

Status and phase: Not yet enrolling; Phase 3

Conditions: Triple-negative Breast Cancer

Treatments: Drug: Epirubicin, cyclophosphamide plus paclitaxel; Drug: Docetaxel plus cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT06795503

2407299-27

Details and patient eligibility

About

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

Enrollment: 1,462 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,462 participants in 2 patient groups

Experimental group

Experimental group

Description:

Docetaxel plus cyclophosphamide

Treatment:

Drug: Docetaxel plus cyclophosphamide

Control group

Active Comparator group

Description:

Epirubicin, cyclophosphamide followed by paclitaxel

Treatment:

Drug: Epirubicin, cyclophosphamide plus paclitaxel