Clinical trial · Interventional
Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation
A Phase II Study of Camrelizumab, Fluzoparib and Nab-paclitaxel in Neoadjuvant Therapy of Her-2 Negative Breast Cancer Patients With HRR Gene Mutation
NCT05761470CI-TRIAL-00064562IMPARPrecruitingPhase 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 study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with HRR gene mutation.
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 |
|---|---|---|---|
| Her-2 Negative Breast Cancer | — | UNRESOLVED | — |
| HRR Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Fluzoparib | Drug | — | UNRESOLVED |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Camrelizumab, Fluzoparib and Nab-paclitaxel
- description
- Participants who confirmed pathogenic or likely pathogenic HRR gene mutation received Camrelizumab and Fluzoparib with nab-paclitaxel from the second cycle followed by nab-paclitaxel for one cycle.
- interventionNames
- Drug: Camrelizumab
- Drug: Fluzoparib
- Drug: Nab-paclitaxel
Primary outcomes (1)
- measure
- Pathologic Complete Response (pCR)
- timeFrame
- Up to 32 weeks
- description
- Pathologic response will be assessed in the surgically resected cancer and lymph nodes after completion of all chemotherapy by the local pathologist as part of routine care. Pathologic complete response is defined as no invasive cancer in the resected breast tissue and lymph nodes (ypT0/Tis, ypN0).
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented Her-2 negative * TNM stage: T1c, N1-N2；T2-4, N0-N2；any T, N3 * No distant metastatic disease * Eastern Cooperative Oncology Group Performance Status: 0\~1 * HRR gene mutation: at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes. Exclusion Criteria: * Patients who are pregnant or lactating at the time of randomization or refuse to contraception. * Patients who have other malignant diseases within 2 years, except for cured skin basal cell carcinoma, breast carcinoma in situ or cervical carcinoma in situ * Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study. * Patients who have myocardial infarction or congestive heart failure, or other serious cardiac disease. * Patients who have used immunosuppressive drug or corticosteroids within 14 days. * Patients who have other diseases which researchers. * Patients who allergy to any of the drugs in this trail.
References
Publications (0)
Data not yet available
No reference posted for this study.