dose-dense AC or EC therapy followed by dose-dense Paclitaxel as neoadjuvant chemotherapy for triple negative operable breast cancer

Phase 2

Not yet recruiting

• Conditions: Breasr cancer

• Registration Number: JPRN-UMIN000040187
• Lead Sponsor: Gifu University Graduate School of Medicine Department of Surgical Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Study Completion: 2022-05-31
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

1)inflammamatory and/or bilateral breast cancer 2)Duplicated/sunchromus/metachromus cancer(DFS less than 5y) 3)Severe complication(cardiovascular, lung, liver disease, homorragic ulcer etc.) 4)febrile, suspicious for infection 5)Intedstitial pneumonia oe pulmonary fibrosis by chest-X/CT 6)Active systhemic infection()HBV,HCV,HIC etc.) 7)Severe allergy to drug 8)Pregnancy,Lactation 9)Uncontrollable mental disease 10)Not suitable for thes study judged by physician/Surgeon

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pCR rate

Secondary Outcome Measures

Name	Time	Method
Response rate Pathological evaluation Breast conserving rate Safety(change of LVEF,Febrile neutropenia,CIPN,Pneumocystis pneumonia) Relative dose intensity Aduvant therapy DFS OS Evaluation of TILs/PD-L1 in biopsy samples Analysis of tumor-related factors in urine and blood(Pre,after 4*dose-dense AC or EC, after*4 dose-dense paclitaxel)