Clinical trial · Interventional
Comparison of TP and TAC Regimens in Neoadjuvant Treatment of TNBC
Comparing TP (Docetaxel + Cisplatin) and TAC (Docetaxel + Doxorubicin + Cyclophosphamide) in Neoadjuvant Therapy for Operable Triple Negative Breast Cancer, A Multicenter, Randomized, Phase II Clinical Trial
- 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)
Previous studies have shown that TNBC is sensitive to DNA crosslinking-related chemotherapeutic drugs such as platinum. However, there is a lack of large sample prospective clinical data to compare the efficacy of TP and EC-T / TEC regimen in the neoadjuvant chemotherapy of TNBC. Besides, the application of anthracycline drugs is limited to a certain extent due to the cardiotoxicity. Based on the above evidence, the researchers hope to explore a more effective and safer new adjuvant therapy for TNBC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel +Cisplatin | Drug | — | UNRESOLVED |
| Docetaxel +doxorubicin+ cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- TAC regimen group
- description
- The control group was treated with TAC (docetaxel 75mg/m2 + adriamycin 50mg /m2 + cyclophosphamide 500mg/m2) for 6 cycles, 21 days as a cycle.
- interventionNames
- Drug: Docetaxel +doxorubicin+ cyclophosphamide
- type
- EXPERIMENTAL
- label
- TP regimen group
- description
- The experimental group was treated with TP (docetaxel 75mg/m2 day 1 + cisplatin 25 mg/m2 day 1,2,3) neoadjuvant chemotherapy for 6 cycles, 21 days as a cycle.
- interventionNames
- Drug: Docetaxel +Cisplatin
Primary outcomes (1)
- measure
- The pathological complete remission rate (pCR rate)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: 18-70. 2. Clinical stage Ⅱ-Ⅲ. 3. triple negative and invasive breast cancer confirmed by histopathology: Triple negative breast cancer is defined as: * negative for ER and PR (IHC nuclear staining \< 10%). * Her-2 negative (IHC 0,1 + without FISH, or IHC 2 + and without FISH amplification). 4. With clinically measurable focus: Measurable lesions observed on ultrasound, mammography, or magnetic resonance imaging (optional) within the month prior to randomization. 5. Organ and bone marrow function tests within 1 month before chemotherapy indicate no contraindications to chemotherapy: * neutrophils count absolute value ≥ 2.0×109/L * hemoglobin ≥ 100g/L * blood platelet ≥ 100×109/L * total bilirubin \< 1.5 ULN (upline of normal value) * creatinine \< 1.5×ULN * AST/ALT \< 1.5×ULN; 6. Cardiac ultrasound EF value ≥ 55%. 7. Females of childbearing age with negative serum pregnancy test 14 days before randomization. 8. ECOG score ≤1. 9. Sign informed consent. Exclusion Criteria: 1. Evidence of metastatic breast cancer (excluding metastatic breast cancer, a chest CT, abdominal ultrasound, or CT and bone scanning should be performed at any time point before diagnosis and randomization; PET/CT scanning can be used as an alternative imaging examination mean) . 2. The patients have received chemotherapy, endocrine therapy, targeted therapy, and radiation therapy for this disease. 3. The patient has a second primary malignant tumor, except for: \- Thoroughly treated skin cancer 4. Due to severe and uncontrollable other medical diseases, researchers believe the existence of chemotherapy contraindications.
References
Publications (0)
Data not yet available