Non-Inferiority Study on MRNA-lncRNA Model in Low-Risk Tr... | NCT06795503

NCT06795503

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group	Experimental	Docetaxel plus cyclophosphamide	Drug: Docetaxel plus cyclophosphamide
Control group	Active Comparator	Epirubicin, cyclophosphamide followed by paclitaxel	Drug: Epirubicin, cyclophosphamide plus paclitaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Docetaxel plus cyclophosphamide	Drug	Docetaxel (T) at a dose of 75 mg/m² was administered intravenously on Day 1 of each cycle, and Cyclophosphamide (C) at a dose of 600 mg/m² was administered intravenously on Day 1 of each cycle as well.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
invasive disease-free survival (iDFS)	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.	Five years

Secondary Outcomes

Measure	Description	Time Frame
Distant recurrence-free survival (DRFS)	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.	Five years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female participants aged ≥18 and ≤70 years.
ECOG performance status of 0 to 1.
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.
Postoperative early-stage breast cancer patients who have undergone radical surgery, with pathological TNM staging of pT1c-3N0-3M0.
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).
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.
Participants must voluntarily join the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up procedures.

Exclusion Criteria:

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