Clinical trial NCT04676997: Neoadjuvant Study of Camrelizumab Plus Chemotherapy in Triple Negative Breast Cancer (TNBC)
Official title: A Phase Ⅱ Study to Evaluate Efficacy and Safety of Camrelizumab Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
Keywords: Neoadjuvant
PD-1
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2020-12-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Negative Breast Cancer (TNBC)


Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed breast cancer
2. 18-70 Years, female;
3. life expectancy is not less than 3 months
4. Histologically documented TNBC (negative human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], and progesterone receptor \[PgR\] status);
5. Stage at presentation: T1c N1-2 or T2-4 N0-2;
6. at least one measurable lesion according to RECIST 1.1;
7. 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
8. Provides tumor tissue specimen to assess tumor programmed death-ligand 1 (PD-L1);
9. 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 Criteria:

1. Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer
2. Inflammatory breast cancer
3. patients who received chemotherapy, endocrine therapy, immunotherapy, biotherapy or TACE within 4 weeks before admission
4. Has participated in an interventional clinical study with an investigational compound within 4 weeks prior to initiation of study treatment
5. 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
6. 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.
7. Major surgical procedure within 4 weeks prior to initiation of study treatment
8. Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus
9. Has a history of (non-infectious) pneumonitis, interstitial lung disease or uncontrollable systematicness diseases
10. 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
11. Has a known history of Human Immunodeficiency Virus (HIV).
12. Has known active Hepatitis B, Hepatitis C or Autoimmune hepatitis
13. 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
14. Has active infection (CTCAE≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment
15. Has evidence of active tuberculosis within 1year prior to initiation of study treatment
16. Prior allogeneic stem cell or solid organ transplantation
17. Pre-existing motor or sensory neuropathy of a severity≥grade 2
18. Has significant cardiovascular disease
19. Treatment with systemic immunostimulatory agents within 4 weeks prior to initiation of study treatment
20. Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment
21. Has a known hypersensitivity to the components of the study treatment or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
22. 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
23. History of neurological or psychiatric disorders, including epilepsy or dementia.
24. any other situation evaluated by researchers

Primary outcomes:
measure: pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
timeFrame: Up to approximately 27-30 weeks
Secondary outcomes:
measure: pCR rate using the definition of ypT0/Tis (i.e., absence of invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement) at the time of definitive surgery
timeFrame: Up to approximately 27-30 weeks
measure: Event-Free Survival (EFS) in all participants
timeFrame: Up to approximately 5 years
measure: Objective Overall Response Rate (ORR)
timeFrame: Up to approximately 25-30 weeks
measure: Adverse events (AEs)
timeFrame: Up to approximately 35 weeks
Other outcomes:
Locations:
city: Jinan
country: China
facility: Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University Recruiting
state: Shandong
Study officials:
References: