Status:
UNKNOWN
Study of Camrelizumab Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
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 C...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04907344
Start Date
June 15 2021
End Date
June 30 2025
Last Update
May 28 2021
Active Locations (2)
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1
Breast Cancer Department I, Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
2
Breast Oncology, Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060