Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Tislelizumab: 200 mg IV infusion every 3 weeks.
With investigator choice chemotherapy:
Nab-paclitaxel or
Paclitaxel or
Gemcitabine + carboplatin
Control Intervention1: NIL: NIL
Sponsors
Dr Ajay Gogia
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed triple negative breast cancer that is HER2 negative estrogen receptor negative and progesterone receptor negative with inoperable locally advanced or metastatic disease at enrolment. 2. Unmutated BRCA. 3. PD L1 combined positive score greater than 1. 4. Female patients aged 18 to 75 years at screening. 5. Eastern Cooperative Oncology Group performance status score 0 to 2. 6. Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1 point 1. 7. Patients who have completed treatment for stage 1 to stage 3 breast cancer if indicated and at least 6 months must have elapsed between completion of treatment with curative intent such as date of primary breast tumor surgery or date of last adjuvant chemotherapy administration whichever occurred last and the first documented local or distant disease recurrence. Note Subjects who received taxane gemcitabine or platinum agents in the neoadjuvant or adjuvant setting can be treated with the same class of chemotherapy if at least 12 months have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence. 8. Asymptomatic central nervous system metastases. 9. Adequate organ and hematological function including hemoglobin at least 85 grams per liter absolute neutrophil count at least 1 point 5 into 10 power 9 per liter platelet count at least 75 into 10 power 9 per liter alanine aminotransferase and aspartate aminotransferase less than or equal to two point five times upper limit of normal or less than or equal to five times upper limit of normal for patients with hepatic metastases and creatinine less than or equal to upper limit of normal or creatinine clearance at least 50 milliliters per minute as calculated by Cockcroft Gault equation. 10. Life expectancy more than or equal to 12 weeks from enrolment. 11. Female subjects of childbearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study treatment. 12. Female subjects of childbearing potential must be willing to use an adequate method of contraception during the study and for 120 days after the last dose of study treatment. 13. Male subjects of childbearing potential must agree to use an adequate method of contraception from the first dose of study therapy through 120 days after the last dose of study therapy. 14. Signed informed consent obtained prior to participation in the study.
Exclusion criteria
Exclusion criteria: 1. Untreated or symptomatic CNS metastases 2. Prior treatment with ICIs. 3. Has a known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer. 4. History of severe hypersensitivity reactions to other monoclonal antibodies or any contraindication to the planned chemotherapy regimen. 5. Severe hypersensitivity to any excipient of Tislelizumab. 6. Participants with autoimmune diseases or history of autoimmune diseases at high risk for relapse. 7. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (exceeding 10 mg daily dose of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment. 8. Known history of HIV or patients with active/symptomatic carrier or chronic hepatitis B virus (HBV). 9. History of interstitial lung disease or non-infections pneumonitis. 10. Any other medical conditions/ risk factors which is deemed unsuitable to receive Tislelizumab therapy as per Investigator s discretion. 11. Pregnant or lactating females 12. Concurrent participation in another therapeutic clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS), defined as the time from initiation of treatment to tumor progression or deathTimepoint: 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate calculated as the proportion of patients achieving complete remission or partial remission evaluated using Response Evaluation Criteria in Solid Tumors version 1 point 1. Overall Survival measured from initiation of treatment until death from any cause. Disease Control Rate calculated as the proportion of patients achieving complete remission partial remission or stable disease evaluated using Response Evaluation Criteria in Solid Tumors version 1 point 1. Clinical Benefit Rate defined as the percentage of patients who achieve complete remission partial remission or stable disease lasting six months or longer evaluated using Response Evaluation Criteria in Solid Tumors version 1 point 1. Duration of Response defined as the time from the first evaluation of complete remission partial remission or stable disease until disease progression.Timepoint: 12 Months | — |
Countries
India
Contacts
Public ContactDr Ajay Gogia
All India Institute of Medical Sciences
Outcome results
None listed