eoadjuvant Concurrent Chemo-radiation with Paclitaxel and Trastuzumab versus Neoadjuvant chemotherapy with trastuzumab followed by sequential radiation in locally advanced Her2 neu positive breast cancers: a phase 2 randomized controlled trial

Cancer Institute0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年2月6日

试验速览

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•1.All female patients with Her2 positive LABC who are planned for CTRT with paclitaxel and trastuzumab as neoadjuvant modality of treatment after multi-speciality board discussion.
•2.The following stages as per AJCC TNM staging 8th edition will be considered as LABC (IIIA, IIIB and IIIC). Except for patients with T4a tumors (chest wall fixity).
•3.Age between 18 to 65 years
•4.Karnofsky performance status score >=70
•5.Normal cardiac function with echocardiography showing Ejection Fraction (EF) > 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.Inflammatory breast cancer.
•4.Male breast cancer
•5.Patients deemed inoperable at presentation due to factors like lymphedema, chest wall fixity or cutaneous nodules extending beyond the confines of the breast.
•6.SGOT (AST) > 2.0 x upper limit of normal (ULN) and SGPT (ALT) >2.0 x ULN and Bilirubin >1.5 x ULN
•7.Serum creatinine > ULN
•8.Patient has received prior radiotherapy to the affected breast
•9.Patients with uncontrolled diabetes mellitus, hypertension or ischemic heart disease.
•10.Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
•11.Hypersensitivity to paclitaxel
•12.Grade 2 or more peripheral neuropathy
•13.Patient not consenting for treatment

发起方

Cancer Institute