Clinical trial · Interventional
Neoadjuvant QL1706 in Patients With Hormone Receptor Positive, HER2-negative Breast Cancer
NEOadjuvant Iparomlimab and Tuvonralimab (QL1706) Plus Chemotherapy in Patients With Hormone Receptor Positive And HER2-Negative Breast Cancer: a Prospective, Single Arm, Multicenter Clinical Trial
NCT07396324CI-TRIAL-00111379NEO-ITHRANrecruitingPhase 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)
This is an prospective, open label, multicenter study to evaluate the efficacy and safety of neoadjuvant Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-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 |
|---|---|---|---|
| HR-positive/HER2-negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Iparomlimab and Tuvonralimab | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- neoadjuvant Iparomlimab and Tuvonralimab (QL1706)
- description
- Iparomlimab and Tuvonralimab (QL1706) in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy
- interventionNames
- Drug: Iparomlimab and Tuvonralimab
- Drug: Paclitaxel
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Proportion of patients with pCR
- timeFrame
- 1-2 weeks after surgery
- description
- Number of patients with pathological complete response/Number of all eligible patients
Secondary outcomes (1)
- measure
- Proportion of patients with adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged ≥18 years * Histologically confirmed hormone receptor positive and human epidermal growth factor receptor 2 (HER2) negative breast cancer * Subjects with at least one evaluable lesion * ECOG 0-1 * Adequate organ function Exclusion Criteria: * Metastatic disease (Stage IV) * Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period
References
Publications (0)
Data not yet available
No reference posted for this study.