Status:
UNKNOWN
Neoadjuvant Study of Camrelizumab Plus Chemotherapy in Triple Negative Breast Cancer (TNBC)
Lead Sponsor:
Shandong Cancer Hospital and Institute
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
The study is being conducted to evaluate the efficacy, safety and tolerability of Camrelizumab Combination With Nab-Paclitaxel and Epirubicin as Neoadjuvant Therapy in Participants With Triple Negativ...
Eligibility Criteria
Inclusion
- Newly diagnosed breast cancer
- 18-70 Years, female;
- 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);
- Stage at presentation: T1c N1-2 or T2-4 N0-2;
- at least one measurable lesion according to RECIST 1.1;
- Adequate function of major organs meets the following requirements:
- Neutrophils ≥ 1.5×10\^9/L
- Platelets ≥ 100×10\^9/L
- Hemoglobin ≥ 90g/L
- lymphocyte≥0.5×10\^9/L
- Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
- ALT and AST ≤ 3 × ULN
- ALP≤ 2.5 × ULN
- BUN and Cr ≤ 1.5 × ULN
- TSH≤ ULN
- Left ventricular ejection fraction (LVEF) ≥ 50%
- QTcF ≤ 470 ms
- Provides tumor tissue specimen to assess tumor programmed death-ligand 1 (PD-L1);
- For women of childbearing potential: agreement to use contraceptive methods. Women who are not postmenopausal or have undergone a sterilization procedure must have a negative serum pregnancy test result within 72 hours prior to initiation of study drug.
Exclusion
- Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer
- Inflammatory breast cancer
- patients who received chemotherapy, endocrine therapy, immunotherapy, biotherapy or TACE within 4 weeks before admission
- Has participated in an interventional clinical study with an investigational compound within 4 weeks prior to initiation of study treatment
- Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
- 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
- Treatment with systemic immunostimulatory agents within 4 weeks prior to initiation of study treatment
- Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment
- 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 :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04676997
Start Date
May 20 2020
End Date
February 28 2024
Last Update
December 21 2020
Active Locations (1)
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1
Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University Recruiting
Jinan, Shandong, China, 250117