Clinical trial · Interventional
TA(E)C-GP Versus A(E)C-T for the High Risk TNBC Patients and Validation of the mRNA-lncRNA Signature
Efficacy and Safety Study of TA(E)C-GP Versus A(E)C-T for the High Risk Triple-negative Breast Cancer Patients Predicted by the Messenger RNA (mRNA)-Long Non-coding RNA (lncRNA) Signature and Validation of the Signature's Efficacy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the efficacy and safety between docetaxel combined with doxorubicin (epirubicin) and cyclophosphamide followed by gemcitabine combined with cisplatin and doxorubicin (epirubicin) combined with cyclophosphamide followed by docetaxel for high risk triple negative breast cancer predicted by the mRNA-lncRNA integrated signature and validation the efficacy of the signature.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| doxorubicin or epirubicin | Drug | — | UNRESOLVED |
| gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- High risk group A
- description
- TA(E)C x 4 cycles to GP x 4 cycles (docetaxel + doxorubicin (epirubicin) + cyclophosphamide to gemcitabine + cisplatin), docetaxel: 75 mg/m2 IV on day 1; doxorubicin: 50 mg/m2 IV on day 1 or epirubicin 75 mg/m2 IV on day 1; cyclophosphamide: 500 mg/m2 IV on day 1; gemcitabine: 1250 mg/m2 IV on day 1 and 8; cisplatin: 75 mg/m2 IV on day 1, dosing interval is 21 days.
- interventionNames
- Drug: docetaxel
- Drug: doxorubicin or epirubicin
- Drug: cyclophosphamide
- Drug: gemcitabine
- Drug: cisplatin
- type
- ACTIVE_COMPARATOR
- label
- High risk group B
- description
- A(E)C x 4 cycles to T x 4 cycles (doxorubicin (epirubicin) + cyclophosphamide to docetaxel), doxorubicin: 60 mg/m2 IV on day 1 or epirubicin 90 mg/m2 IV on day 1; cyclophosphamide: 600 mg/m2 IV on day 1; docetaxel: 100 mg/m2 IV on day 1, dosing interval is 21 days.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: 18-70 years old 2. Expected survival \> 12 months 3. Baseline Eastern Cooperative Oncology Group Performance Status rating 0-1 4. Naïve to chemotherapy or hormonal treatments 5. Pathology confirmed invasive ductal carcinoma of breast 6. Triple negative breast cancer confirmed by pathology 7. No concurrent malignancy (except controlled cervical carcinoma in situ or basal cell carcinoma of skin) 8. No advanced metastasis or metastasis involving brain or liver 9. Adequate bone marrow function, blood routine examination shows neutrophil count ≥ 1.5x109/L, hemoglobin level ≥ 100 g/L, Platelets ≥ 100 x 109/L 10. Adequate liver and kidney function, serum aminotransferase (AST) ≤ 60 Unit/L, serum total bilirubin ≤ 2.5 times Upper Limit of Normal, serum creatinine ≤110μmol/L, urea nitrogen ≤7.1mmol/L 11. No coagulation abnormality 12. Normal heart function, with normal ECG and left ventricular ejection fraction ≥ 55% 13. Women of childbearing age agree to take reliable contraceptive measures during clinical trials, and negative serum or urine pregnancy test within 7 days prior to administration 14. No coagulation abnormality 15. Sign the informed consent statement and voluntarily receive follow-ups, treatments, laboratory tests and other research procedures according to protocol. Exclusion Criteria: 1. Previous regional or systemic treatment for breast cancer (include but not limited to chemotherapy, radiotherapy, targeted therapy, other clinical trials) 2. Inflammatory breast cancer, bilateral breast cancer or breast cancer already with distant metastasis 3. Complicated with uncontrolled lung disease, severe infection, active peptic ulcer, blood clotting disorders, severe uncontrolled diabetes, connective tissue disorders or bone marrow suppression, and intolerance to neoadjuvant therapy or related treatment 4. Peripheral neuropathy \>1 degree caused by any reason 5. History of congestive heart failure, uncontrolled or symptomatic angina, arrhythmias or history of myocardial infarction, refractory hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg); 6. Breast cancer during lactation or pregnancy 7. Mental illness or incompliance to treatment caused by other reasons 8. Known history of severe hypersusceptibility to any agents used in the treatment protocol 9. Patients received major surgery or suffered from severe trauma within 2 months of first administration 10. Currently enroll or recently used (30 days within enrollment) other agent under research or involved in other trial 11. Known to be infected with human immunodeficiency virus (HIV) 12. Other circumstances considered to be inappropriate to be enrolled by researchers
References
Publications (1)
- DERIVEDHe M, Jiang YZ, Gong Y, Fan L, Liu XY, Liu Y, Tang LC, Mo M, Hou YF, Di GH, Liu GY, Yu KD, Wu J, Yan X, Zeng XH, Fu DY, Song CG, Zhuang ZG, Wu KJ, Wang J, Wang ZH, Shao ZM. Intensive chemotherapy versus standard chemotherapy among patients with high risk, operable, triple negative breast cancer based on integrated mRNA-lncRNA signature (BCTOP-T-A01): randomised, multicentre, phase 3 trial. BMJ. 2024 Oct 23;387:e079603. doi: 10.1136/bmj-2024-079603. PMID 39442958