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Neoadjuvant Phase II Study of Tislelizumab combined with chemotherapy in Triple Negative Breast Cancer

A prospective, single-arm clinical study on Tislelizumab in combination with albumin-bound paclitaxel followed by epirubicin and cyclophosphamide in the neoadjuvant treatment of triple negative breast cancer (TREND)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035262
Enrollment
Unknown
Registered
2020-08-05
Start date
2020-08-31
Completion date
Unknown
Last updated
2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Sponsors

Liaoning Province Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Understand the content of the clinical trial and agree with the participants; 2. Subjects aged 18-65 years old; 3. The subjects diagnosed as TNBC by pathology; 4. Patients with newly diagnosed and untreated non metastatic breast cancer confirmed by imaging evaluation; 5. Patients who have not received any treatment before; 6. Subjects with T >= 3cm or ln (+); 7. Subjects with ECoG score of 0-1; 8. Subjects with good organ function (blood cells, heart, liver, kidney, coagulation); 9. Informed consent of patients and written consent; 10. The patients had good compliance and voluntarily accepted follow-up, treatment, laboratory examination and other research steps according to the plan.

Exclusion criteria

Exclusion criteria: 1. Has the second primary malignant tumor within the last 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix; 2. Received chemotherapy, targeted therapy and radiation therapy in the past 12 months; 3. Has received anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs; 4. Has an active autoimmune disease requiring systemic treatment in the past 2 years; 5. Diagnosed with immunodeficiency or received immunosuppressive therapy within 1 week; 6. History of human immunodeficiency virus infection; 7. History of non-infectious pneumonia with glucocorticoid treatment; 8. Current pneumonia, active tuberculosis, active hepatitis B virus or hepatitis C virus infection; 9. Active infections undergoing systemic treatment; 10. Currently participating in other clinical trials; 11. Pregnant or lactating women or fertile women who do not use contraception; 12. Having other severe acute or chronic physical or mental problems, or abnormal laboratory tests, which may increase the risk associated with study participation or drug use, or interfere with the judgment of study results, and are deemed unfit for study participation by the investigator.

Design outcomes

Primary

MeasureTime frame
Pathological complete response;

Secondary

MeasureTime frame
objective response rate;

Countries

China

Contacts

Public ContactQiang Zhang

Liaoning Province Cancer Hospital

zhangqiang8220@163.com+86 18900917799

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026