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

NCT ID: NCT06795503

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1462 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2031-07-31

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

Conditions

Triple-negative Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Docetaxel plus cyclophosphamide

Group Type: EXPERIMENTAL

Docetaxel plus cyclophosphamide

Intervention Type: 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.

Control group

Epirubicin, cyclophosphamide followed by paclitaxel

Group Type: ACTIVE_COMPARATOR

Epirubicin, cyclophosphamide plus paclitaxel

Intervention Type: DRUG

Patients in the control group received the EC-P regimen chemotherapy, with a cycle length of 21 days, for a total of 8 cycles. The specific treatment was as follows: Epirubicin (E) at a dose of 90 mg/m² and Cyclophosphamide (C) at a dose of 600 mg/m² were administered intravenously on Day 1 of each cycle for the first 4 cycles. This was followed by Paclitaxel (P) at a dose of 80 mg/m², administered intravenously on Days 1, 8, and 15 of each cycle for the subsequent 4 cycles.

Interventions

Docetaxel plus cyclophosphamide

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.

Intervention Type: DRUG

Epirubicin, cyclophosphamide plus paclitaxel

Patients in the control group received the EC-P regimen chemotherapy, with a cycle length of 21 days, for a total of 8 cycles. The specific treatment was as follows: Epirubicin (E) at a dose of 90 mg/m² and Cyclophosphamide (C) at a dose of 600 mg/m² were administered intravenously on Day 1 of each cycle for the first 4 cycles. This was followed by Paclitaxel (P) at a dose of 80 mg/m², administered intravenously on Days 1, 8, and 15 of each cycle for the subsequent 4 cycles.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Shao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zhimin Shao, Professor

Role: CONTACT

zhimingshao@yahoo.com

08664175590 Ext. 88807

Other Identifiers

2407299-27

Identifier Type: -

Identifier Source: org_study_id