A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator’s Choice of Chemotherapy in Patients who are not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast02)

AstraZeneca Pharma India Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

阶段: 3 期
状态: 尚未招募
发起方: AstraZeneca Pharma India Ltd

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1. Participant must be = 18 years (= 20 years in Japan) at the time of screening.
•2. Histologically or cytologically documented locally recurrent inoperable or metastatic
•TNBC. TNBC is defined as:
•Negative for ER with < 1% of tumour cells positive for ER on IHC.
•Negative for progesterone receptor with < 1% of tumour cells positive for progesterone receptor on IHC.
•Negative for HER2 with 0 or 1+ intensity on IHC or 2+ intensity on IHC and negative by in situ hybridisation per the ASCO-CAP HER2 guideline
•3. No prior chemotherapy or targeted systemic therapy for metastatic or locally recurrent inoperable breast cancer.
•4. Not a candidate for PD-1/PD-L1 inhibitor therapy, defined as:
•Participants whose tumours are PD-L1-negative, or
•Participants whose tumours are PD-L1-positive and have:
•1)relapsed after prior PD-1/PD-L1 inhibitor therapy for early-stage breast cancer,
•2) comorbidities precluding PD-1/PD-L1 inhibitor therapy, or
•3) no regulatory access to pembrolizumab [participant’s country does not have regulatory approval at the time of screening]).
•5. At least 1 measurable lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as = 10 mm in the longest diameter (except lymph nodes, which must have short axis = 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI), and is suitable for accurate repeated measurements.
•6. ECOG PS 0 or 1
•7. Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, capecitabine, carboplatin, or eribulin), per investigator assessment.
•8. Has had an adequate treatment washout period before Cycle 1 Day 1
•9. Written confirmation of tumour sample needs to be available prior to enrolment and tumour samples should be available prior to randomisation.
•10. Participants with a history of previously treated neoplastic spinal cord compression or clinically inactive brain metastases, who require no treatment with corticosteroids or anticonvulsants may be included in the study, if they have recovered from acute toxic effects of radiotherapy.
•11. Adequate organ and bone marrow function within 7 days before day of first dosing
•. Haemoglobin = 9.0 g/dL (red blood cell/plasma transfusion is not allowed within 1 week prior to screening assessment).
•Absolute neutrophil count = 1.5 × 109/L (granulocyte colony-stimulating factor administration is not allowed within 1 week prior to screening assessment).
•Platelet count = 100 × 109/L (platelet transfusion is not allowed within 1 week prior to screening assessment).
•Total bilirubin (TBL) = 1.5 × upper limit of normal (ULN) if no liver metastases or < 3 × ULN in the presence of documented Gilbert’s syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 × ULN for AST/ALT ( < 5 × ULN in participants with liver metastases).
•Calculated CrCL = 30 mL/minute as determined by Cockcroft-Gault (using actual body weight)
•12. Minimum life expectancy of 12 weeks.

排除标准

•Inclusion criteria:
•1. Participant must be = 18 years (= 20 years in Japan) at the time of screening.
•2. Histologically or cytologically documented locally recurrent inoperable or metastatic
•TNBC. TNBC is defined as:
•Negative for ER with < 1% of tumour cells positive for ER on IHC.
•Negative for progesterone receptor with < 1% of tumour cells positive for progesterone receptor on IHC.
•Negative for HER2 with 0 or 1+ intensity on IHC or 2+ intensity on IHC and negative by in situ hybridisation per the ASCO-CAP HER2 guideline
•3. No prior chemotherapy or targeted systemic therapy for metastatic or locally recurrent inoperable breast cancer.
•4. Not a candidate for PD-1/PD-L1 inhibitor therapy, defined as:
•Participants whose tumours are PD-L1-negative, or
•Participants whose tumours are PD-L1-positive and have:
•1)relapsed after prior PD-1/PD-L1 inhibitor therapy for early-stage breast cancer,
•2) comorbidities precluding PD-1/PD-L1 inhibitor therapy, or
•3) no regulatory access to pembrolizumab [participant’s country does not have regulatory approval at the time of screening]).
•5. At least 1 measurable lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as = 10 mm in the longest diameter (except lymph nodes, which must have short axis = 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI), and is suitable for accurate repeated measurements.
•6. ECOG PS 0 or 1
•7. Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, capecitabine, carboplatin, or eribulin), per investigator assessment.
•8. Has had an adequate treatment washout period before Cycle 1 Day 1
•9. Written confirmation of tumour sample needs to be available prior to enrolment and tumour samples should be available prior to randomisation.
•10. Participants with a history of previously treated neoplastic spinal cord compression or clinically inactive brain metastases, who require no treatment with corticosteroids or anticonvulsants may be included in the study, if they have recovered from acute toxic effects of radiotherapy.
•11. Adequate organ and bone marrow function within 7 days before day of first dosing
•. Haemoglobin = 9.0 g/dL (red blood cell/plasma transfusion is not allowed within 1 week prior to screening assessment).
•Absolute neutrophil count = 1.5 × 109/L (granulocyte colony-stimulating factor administration is not allowed within 1 week prior to screening assessment).
•Platelet count = 100 × 109/L (platelet transfusion is not allowed within 1 week prior to screening assessment).
•Total bilirubin (TBL) = 1.5 × upper limit of normal (ULN) if no liver metastases or < 3 × ULN in the presence of documented Gilbert’s syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 × ULN for AST/ALT ( < 5 × ULN in participants with liver metastases).
•Calculated CrCL = 30 mL/minute as determined by Cockcroft-Gault (using actual body weight)
•12. Minimum life expectancy of 12 weeks.
•Medical Conditions
•1. As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, uncontrolled hypertension

研究者

发起方

AstraZeneca Pharma India Ltd

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