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NCT Number: NCT06795503

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

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

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Key information

Conditions

Triple-negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. invasive disease-free survival (iDFS)

    Time frame: 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 outcomes

  1. Distant recurrence-free survival (DRFS)

    Time frame: 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.

  2. Overall survival (OS)

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhimin Shao, Professor

CONTACT

[email protected]

08664175590 Ext. 88807

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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