Clinical trial · Interventional
Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer（UPGRADE-TNBC）
NCT06910072CI-TRIAL-00122470UPGRADE-TNBCenrolling by invitationPhase 2 / Phase 3ClinicalTrials.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)
This is a prospective, single-arm, multicenter study to observe and evaluate the efficacy and safety of paclitaxel polymeric micelles and carboplatin in combination with iparomilimab and tuvonralimab in neoadjuvant therapy for triple-negative breast cancer. The main endpoint of the study is pCR, 32 patients are scheduled to be enrolled.
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 |
|---|---|---|---|
| Neoadjuvant Therapy | — | UNRESOLVED | — |
| Triple-Negative Breast Cancer (TNBC) | Triple-Negative Breast Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy combined with immunotherapy
- description
- paclitaxel polymeric micelles 230-300mg/m2, d1 carboplatin AUC=5, d1 iparomilimab and tuvonralimab 5mg/kg, d1 Every 3 weeks (Q3W) is a cycle, a total of 6 cycles.
- interventionNames
- Drug: paclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab
Primary outcomes (1)
- measure
- Primary endpoint
- timeFrame
- After surgery（within 1 month）
- description
- Pathological complete response (pCR) rates in patients with triple-negative breast cancer
Secondary outcomes (3)
- measure
- Objective response rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Triple-negative breast cancer * The diameter of the primary tumor must be greater than 2cm, and the clinical stage should be II-III * There is sufficient primary organ function * The ECOG (PS) score is 0 or 1 * Expected survival ≥ 6 months * The serum pregnancy test was negative. Use highly effective methods of contraception during the study period and for 180 days after the last dose of the study drug, and do not breastfeed Exclusion Criteria: * Bilateral breast cancer * There is a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) * A history of invasive or metastatic breast cancer * Any malignancy diagnosed within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma * There is an immune deficiency disease * The presence of any autoimmune disease that still requires treatment or a history of prior autoimmune disease
References
Publications (0)
Data not yet available
No reference posted for this study.