Concurrent chemo-radiotherapy with paclitaxel in locally advanced breast cancer: prospective observational data collection

Cancer Institute0 sites200 target enrollmentTBD

Overview

Phase: 未知
Intervention: Not specified
Conditions: Health Condition 1: C508- Malignant neoplasm of overlappingsites of breast
Sponsor: Cancer Institute
Enrollment: 200
Status: Completed
Last Updated: 3 years ago

No summary available.

Registry

who.int

Start Date

TBD

End Date

December 15, 2022

Last Updated

3 years ago

Study Type

Observational

Sponsor

Cancer Institute

•1\.All female patients with locally advanced carcinoma breast who are planned for CTRT with paclitaxel as neoadjuvant modality of treatment after multi\-speciality board discussion.
•2\.The following stages as per AJCC TNM staging will be considered as LABC (IIIA, IIIB and IIIC). Except 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.