Camrelizumab in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-negative Breast Cancer

Launched by BLOKHIN'S RUSSIAN CANCER RESEARCH CENTER · Jul 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for women with early or locally advanced triple-negative breast cancer (TNBC), a type of breast cancer that can be more aggressive and harder to treat. The trial is testing a drug called Camrelizumab combined with chemotherapy before surgery, to see if this combination is safe and helps shrink the cancer effectively. This treatment given before surgery is called neoadjuvant therapy and aims to improve the chances of successful surgery and better outcomes.

Women aged 18 to 65 years old who have been diagnosed with triple-negative breast cancer that has not spread to other parts of the body may be eligible to join. To participate, patients must not have received prior treatments for this cancer, must have a tumor that can be measured, and be in generally good health with normal organ function. Women who join will receive Camrelizumab along with chemotherapy before their planned surgery, and the study team will closely monitor their response to treatment and any side effects. It’s important to note that women who are pregnant, breastfeeding, or have certain health conditions may not be eligible. This study is currently not yet recruiting but aims to offer a promising new treatment option for early-stage triple-negative breast cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• 1) 18-65 Years, female; 2) Histologically documented Triple Negative Breast Cancer (TNBC) patients; 3) Previously untreated non-metastatic (M0) TNBC, T3-4NanyM0 или TanyN+M0 3) Promising radical surgical treatment; 4) At least one measurable lesion according to RECIST 1.1; 5) Life expectancy is not less than 3 months; 6) ECOG: 0～1; 7) Adequate function of major organs meets the following requirements:
• • 8) Neutrophils ≥ 1.5×10\^9/L Hemoglobin ≥ 90g/L Platelets ≥ 100×10\^9/L Total bilirubin≤ 1.5 × the upper limit of normal (ULN) ALT and AST ≤ 2.5 × ULN Serum creatinine ≤1.5 × ULN, Endogenous creatinine clearance ≥50mL/min;
• • 9) Left ventricular ejection fraction (LVEF) ≥50% or ≥ limit of normal (LLN) was evaluated by echocardiography (ECHO) or Multigated Acquisition (MUGA); 10) Women with childbearing potential who are must agree to take effective contraceptive measures during the study period and ≥120 days after the last administration of the study drug, and must have a negative serum pregnancy test result within 7 days prior to initiation of study drug.
• • 11) The patient voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up;
• Exclusion Criteria:
• • 1. Has participated in an interventional clinical study with an investigational compound within 4 weeks prior to initiation of study treatment;
• • 2. 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;
• • 3. 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;
• • 4. Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus;;
• • 5. Has a history of (non-infectious) pneumonitis, interstitial lung disease or uncontrollable systematicness diseases, including pulmonary fibrosis, acute lung disease, etc.;
• • 6. Administration of a live attenuated vaccine within 30 days prior to initiation of study treatment or anticipation of need for such a vaccine during the study;
• • 7. Has active infection (CTCAE≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment;
• • 8. Has a history of serious cardiovascular disease, including myocardial infarction, acute coronary syndrome or coronary angioplasty/stent implantation/bypass grafting history in the past 6 months, and have level II-IV congestion Heart failure (CHF), or III NYHA and IV CHF history;
• • 9. Prior allogeneic stem cell or solid organ transplantation
• • 10. History of neurological or psychiatric disorders, including schizophrenia, severe depressive disorder, bipolar disorder, etc.;
• • 11. Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• • 12. History of severe hypersensitivity reactions to other monoclonal antibodies, or intravenous infusion, or Doxorubicin, or cyclophosphamide, or paclitaxel, or carboplatine
• • 13. 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;
• • 14. Any other situation evaluated by researchers.