Triple-negative Breast CancerPhase 3NCT06795503
Non-Inferiority Study on MRNA-lncRNA Model in Low-Risk Triple-Negative Breast Cancer Patients
A Phase 3 study testing Docetaxel plus cyclophosphamide and Epirubicin, cyclophosphamide plus paclitaxel in people with Triple-negative Breast Cancer, run by Fudan University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple-negative Breast Cancer
- What is being tested?
- Docetaxel plus cyclophosphamide and Epirubicin, cyclophosphamide plus paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,462 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Jul 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Docetaxel plus cyclophosphamide, Epirubicin, cyclophosphamide plus paclitaxel
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel plus cyclophosphamideDrug
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 paclitaxelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Docetaxel plus cyclophosphamide Receives: Drug: Docetaxel plus cyclophosphamide |
| Control group | Active comparator | Epirubicin, cyclophosphamide followed by paclitaxel Receives: Drug: Epirubicin, cyclophosphamide plus paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Five years
Secondary outcomes (3)
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.
Measured: Five years
Overall survival (OS)
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.
Measured: Five years
Safety according to CTCAE v5.0 (Common Terminology Criteria for Adverse Events, version 5.0)
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.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,462 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795503
- Sponsor's protocol ID
- 2407299-27
- Status last verified
- Jan 2025
- First submitted
- 4 Oct 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Inferiority Study on MRNA-lncRNA Model in Low-Risk Triple-Negative Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06795503
- Acronym / sponsor ID
- 2407299-27
- Conditions
- Triple-negative Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,462 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy and safety of different adjuvant chemotherapy regimens for low-risk triple-negative breast cancer patients predicted by mRNA-lncRNA model
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Docetaxel plus cyclophosphamideDocetaxel plus cyclophosphamide |
| Control group | Active comparator | Drug: Epirubicin, cyclophosphamide plus paclitaxelEpirubicin, cyclophosphamide followed by paclitaxel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel plus cyclophosphamideDocetaxel (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. | Drug | Experimental group |
| Epirubicin, cyclophosphamide plus paclitaxelPatients 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. | Drug | Control group |
Primary outcome
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.
3 secondary outcomes
Distant recurrence-free survival (DRFS)
Time frame: Five years
Overall survival (OS)
Time frame: Five years
Safety according to CTCAE v5.0 (Common Terminology Criteria for Adverse Events, version 5.0)
Time frame: Five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel plus cyclophosphamide and Epirubicin, cyclophosphamide plus paclitaxel in people with Triple-negative Breast Cancer, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Shao, Professor (08664175590 Ext. 88807, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
invasive disease-free survival (iDFS) (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.