Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA)
NCT Number: NCT06510465
Acronym: NeoURANIA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer
Interventions: DRUG: utidelone|DRUG: Cisplatin|DRUG: Trastuzumab|DRUG: Pertuzumab
Sponsor: RenJi Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 143
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2032-03-31
Locations: Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai, 200127, China|Renji Hospital, Shanghai, China

Summary:
This study is a prospective, multi-center, single-arm, two-cohort, exploratory study, aiming to explore the effectiveness and safety of neoadjuvant treatment with weekly utidelone combined with cisplatin in breast cancer patients.

Primary Outcome Measures: pCR, ypT0/is ypN0, through surgery completion, an average of 16 weeks
Secondary Outcome Measures: breast pCR, ypT0/is, through surgery completion, an average of 16 weeks|RCB 0/I rate, ratio of patients who achieved RCB 0 or RCB I, through surgery completion, an average of 16 weeks|RCB class, RCB 0, RCB I, RCB II, RCB III, through surgery completion, an average of 16 weeks|Rate of lymph node negative, ratio of patients who achieved lymph node negative, through surgery completion, an average of 16 weeks|ORR by physical examination, ratio of patients who achieved complete response or partial response by physical examination, After completing neoadjuvant therapy before surgery, an average of 16 weeks|ORR by MRI, ratio of patients who achieved complete response or partial response by MRI, After completing neoadjuvant therapy before surgery, an average of 16 weeks|CBR by physical examination, ratio of patients who achieved complete response or partial response or stable disease by physical examination, After completing neoadjuvant therapy before surgery, an average of 16 weeks|CBR by MRI, ratio of patients who achieved complete response or partial response or stable disease by MRI, After completing neoadjuvant therapy before surgery, an average of 16 weeks|iDFS, It is defined as the time from first dose of study intervention administration to the first occurrence of ipsilateral invasive cancer recurrence, contralateral invasive breast cancer, local and/or regional invasive cancer recurrence, distant metastasis or death from any cause., 2year,3year,5year,8year,10year|EFS, It is defined as the time from first dose of study intervention administration to the first occurrence of local and/or regional recurrence, contralateral breast cancer, distant metastasis or death from any cause., 2year,3year,5year,8year,10year|DDFS, It is defined as the time from first dose of study intervention administration to the first distant metastasis or death from any cause., 2year,3year,5year,8year,10year|OS, It is defined as the time from first dose of study intervention administration to death from any cause., 2year,3year,5year,8year,10year|Quality of Life, EORTC-QLQ-C30, Through study completion，an average of 1 year|Quality of Life, EORTC-QLQ-BR23, Through study completion，an average of 1 year|Safety, Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Through study completion，an average of 1 year|Combine with weekly paclitaxel with cispltin in HER2-negative and HER2-positive patients, Combine with weekly paclitaxel with cispltin in HER2-negative and HER2-positive patients, After completing neoadjuvant therapy before surgery, an average of 16 weeks