Clinical trial · Interventional
Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer
NCT03907800CI-TRIAL-00061773NeoPATHunknownPhase 2ClinicalTrials.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 evaluate the efficacy and safety of nab-paclitaxel combined with carboplatin for Chinese patients with triple-negative and HER2-positive breast cancer in the neoadjuvant setting.
Conditions
Conditions (3)
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 |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Herceptin | Drug | Trastuzumab | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nab-paclitaxel + Carboplatin ± Herceptin
- interventionNames
- Drug: Nab-paclitaxel
- Drug: Carboplatin
- Drug: Herceptin
Primary outcomes (1)
- measure
- Pathological complete response (ypT0/is ypN0) rate
- timeFrame
- 16 weeks (at the time of definitive surgery)
- description
- Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.
Secondary outcomes (5)
- measure
- Invasive disease-free survival (IDFS)
- timeFrame
- 5 years
- description
- IDFS is defined as the time period between registration and first event (ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, second primary nonbreast invasive cancer)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures. 2. Age at diagnosis ≥ 18 years, female. 3. Histologically confirmed diagnosis of HER2-opsitive or triple-negative breast cancer. ER/PR-negativity is defined as ≤1% stained cells; HER2-positivity is defined as IHC 3+ or in-situ hybridisation (ISH) ratio \>2.0. 4. cT2-4NanyM0 or cTanyN1-3M0 5. ECOG ≤ 1, LVEF ≥ 55%. 6. Laboratory requirements: for hematology, absolute neutrophil count (ANC) ≥ 1.5 × 109 / L and platelets ≥ 100 × 109 / L and hemoglobin ≥ 90 g/L; for hepatic function, total bilirubin ≤ 1.5 × UNL, AST and ALT ≤ 2.5 × UNL; for renal function, SCr ≤ 1.5 × UNL 7. Patients must be available and compliant for treatment and follow-up. Exclusion Criteria: 1. Prior chemotherapy, endocrine therapy or radiation therapy for any malignancy. 2. Known or suspected congestive heart failure (\> NYHA I) 3. Currently active infection or severe symptomatic visceral disease. 4. Definite contraindications for the use of corticosteroids or known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol 5. rior malignancy with a disease-free survival of \< 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri. 6. Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry. 7. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.
References
Publications (1)
- DERIVEDWu J, Liu D, Chen M, Lin C, Ding S, Hong J, Gao W, Zhu S, Chen X, Huang O, He J, Chen W, Li Y, Shen K, Zhu L. Anthracycline-Free Neoadjuvant Therapy With Nab-Paclitaxel and Carboplatin in Non-Luminal Breast Cancer: A Single-Arm Clinical Trial. Int J Cancer. 2026 Aug 17. doi: 10.1002/ijc.70666. Online ahead of print. PMID 42608991