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

NCT06795503 | Not Yet Recruiting Phase 3

• 1 other identifier: 2407299-27
• Study Type: interventional
• Target: 1,462
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Distant recurrence-free survival (DRFS)

  Five years

• Overall survival (OS)

  Five years

• Safety according to CTCAE v5.0 (Common Terminology Criteria for Adverse Events, version 5.0)

  Five years

Study Arms (2)

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

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.

Experimental group

Epirubicin, cyclophosphamide plus paclitaxel 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.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Docetaxel; Cyclophosphamide; Epirubicin; Paclitaxel

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Zhimin Shao, Professor

CONTACT

08664175590 Ext. 88807; zhimingshao@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: January 28, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): July 1, 2031
• Last Updated: January 28, 2025

Record last verified: 2025-01