Clinical trial · Interventional
Study of Camrelizumab Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
A Multicenter, Open, Randomized Controlled Study of Camrelizumab+ Nab-paclitaxel + Carboplatin Versus Nab-paclitaxel + Carboplatin as Neoadjuvant Therapy for Triple Negative Breast Cancer (TNBC)
NCT04907344CI-TRIAL-00052023unknownPhase 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)
The purpose of this study is to evaluate the efficacy and safety of Camrelizumab in Combination With Nab-Paclitaxel and carboplatin as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC).
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 |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Nab-Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1: Camrelizumab + Chemotherapy
- interventionNames
- Drug: Camrelizumab
- Drug: Nab-Paclitaxel
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- Part 2: Camrelizumab + Chemotherapy
- interventionNames
- Drug: Camrelizumab
- Drug: Nab-Paclitaxel
- Drug: Carboplatin
- type
- ACTIVE_COMPARATOR
- label
- Part 2: Chemotherapy
- interventionNames
- Drug: Nab-Paclitaxel
- Drug: Carboplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed breast cancer; * 18-75 Years, female; * ECOG Performance Status of 0-1; * Life expectancy is not less than 3 months; * Histologically documented TNBC (negative human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], and progesterone receptor \[PgR\] status); * Tumor stage: II-III; * At least one measurable lesion according to RECIST 1.1; * Adequate hematologic and organ function.; * Must be willing to use an adequate method of contraception for the course of the study. Exclusion Criteria: * Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer; * Inflammatory breast cancer; * Has received prior any anti-tumor therapy within the past 12 months prior to signing informed consent, including chemotherapy, targeted therapy, radiation therapy, immunotherapy, biotherapy and TACE; * Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 \[CTLA-4\]; * Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer; * Major surgical procedure within 4 weeks prior to initiation of study treatment; * Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus; * Has a history of (non-infectious) pneumonitis, interstitial lung disease or uncontrollable systematicness diseases; * Administration of a live attenuated vaccine within 28 days prior to initiation of study treatment or anticipation of need for such a vaccine during the study; * Has a known history of Human Immunodeficiency Virus (HIV); * Has known active Hepatitis B, Hepatitis C or Autoimmune hepatitis; * Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; * Has active infection (CTCAE≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment; * Has evidence of active tuberculosis within 1year prior to initiation of study treatment; * Prior allogeneic stem cell or solid organ transplantation; * Pre-existing motor or sensory neuropathy of a severity≥grade 2; * Has significant cardiovascular disease; * Has a known hypersensitivity to the components of the study treatment or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; * Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial; * History of neurological or psychiatric disorders, including epilepsy or dementia; * Any other situation evaluated by researchers.
References
Publications (0)
Data not yet available
No reference posted for this study.