Clinical trial · Interventional
Albumin-bound Paclitaxel and Carboplatin Versus Epirubicin and Docetaxel for Triple-negative Breast Cancer
Albumin-bound Paclitaxel Combined With Carboplatin Versus Epirubicin Combined With Docetaxel as Neoadjuvant Therapy for Triple-negative Breast Cancer: a Multicenter Randomized Controlled Phase IV Clinical Trial
NCT04136782CI-TRIAL-00052786recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To investigate the efficacy of albumin-bound paclitaxel combined with carboplatin versus epirubicin combined with docetaxel as neoadjuvant therapy for triple-negative breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Albumin-bound paclitaxel combined with carboplatin | Drug | — | UNRESOLVED |
| Epirubicin combined with docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Trial group
- description
- 55 cases of triple-negative breast cancer will be assigned into a trial group.
- interventionNames
- Drug: Albumin-bound paclitaxel combined with carboplatin
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- 55 cases of triple-negative breast cancer will be assigned into a control group.
- interventionNames
- Drug: Epirubicin combined with docetaxel
Primary outcomes (1)
- measure
- Pathologic complete remission rate
- timeFrame
- 5 years after treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * patients developing breast cancer as confirmed by X-ray examination, cancer tissue negative for estrogen receptor, progesterone receptor and HER2, and tumor stage II-III; * estimated survival \> 3 months; * presence of clinically measurable lesions; * Karnofsky functional status score ≥ 70; * normal routine blood test results, normal liver and kidney function, and near normal electrocardiographic manifestations; * age at 18-70 years. Exclusion Criteria: * stage IV breast cancer patients with bone metastasis or other distant metastasis; * severe renal insufficiency; * older adult patients with severe organic diseases such as heart and lung diseases, who are not estimated to be able to tolerate chemotherapy; * those who have received antineoplastic therapy; * those who have received neoadjuvant chemotherapy but fail in 2 cycles of neoadjuvant chemotherapy and switch to other regimens or terminate chemotherapy; * those with history of other malignant tumors; * those with severe heart, liver, and kidney organ dysfunction or poor health who cannot tolerate chemotherapy, or those who cannot tolerate chemotherapy and switch to other therapeutic regimens; * those with mental and nervous system diseases who cannot comply with treatment; * those with dexamethasone intolerance or those who are highly allergic to any drug in neoadjuvant chemotherapy; * pregnant or lactating women; * those who are participating in other trials.
References
Publications (0)
Data not yet available
No reference posted for this study.