Evaluating the role of addition of low-dose nivolumab and concurrent radiation in patients with triple negative breast cancer (TNBC) receiving neoadjuvant chemotherapy (NACT): a 4 arm, phase 2 Randomised controlled trial (RCT) - Nil

Cancer Institute0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1. All female patients with Stage II and III TNBC who are planned for neoadjuvant modality of treatment after multispeciality board discussion.
•2. Age between 18 to 70 years
•3. Karnofsky performance status score greater than or equal to 70
•4. Normal cardiac function with echocardiography showing Ejection Fraction (EF) greater than 50%

•1. Patients with metastatic disease
•2. Patients with chest wall fixity of tumor, as they are not considered for surgery after completion of neoadjuvant treatment.
•3. Male breast cancer
•4. Patients deemed inoperable at presentation due to factors like lymphedema, chest wall fixity or cutaneous nodules extending beyond the confines of the breast.
•5. SGOT (AST) greater than 2.0 times upper limit of normal (ULN) and SGPT (ALT) greater than 2.0 times ULN and Bilirubin greater than 1.5 times ULN
•6. Serum creatinine greater than ULN
•7. Patient has received prior radiotherapy to the affected breast
•8. Patients with uncontrolled diabetes mellitus, hypertension or ischemic heart disease.
•9. Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
•10. Hypersensitivity to paclitaxel
•11. Grade 2 or more peripheral neuropathy
•12. Patients with known auto-immune conditions
•13. Patient not consenting for treatment

发起方

Cancer Institute