Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05673629
Status:
RECRUITING
Last Update Posted:
2023-11-08
First Post:
2022-12-30
Brief Title:
Utidelone in Combination With AC Versus Docetaxel in Combination With AC for Neoadjuvant Chemotherapy in Patients With HER2-negative Breast Cancer
Sponsor:
Beijing Biostar Pharmaceuticals Co Ltd
Organization:
Beijing Biostar Pharmaceuticals Co Ltd
Study Overview
Official Title:
A Phase III Open-label Randomized Controlled Study of Utidelone in Combination With AC Versus Docetaxel in Combination With AC for Neoadjuvant Chemotherapy in Patients With High-risk Early-stage or Locally Advanced HER2-negative Breast Cancer
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone plus AC versus Docetaxel plus AC as neoadjuvant chemotherapy in high-risk HER2-negative early-stage or locally advanced breast cancer
In this phase III multi-center open-label randomized controlled study 552 subjects will be enrolled and randomly assigned in a 11 ratio to either the Utidelone plus AC group or the docetaxel plus AC group stratified by hormone receptor status ER andor PgR positive vs ER and PgR negative
In this phase III multi-center open-label randomized controlled study 552 subjects will be enrolled and randomly assigned in a 11 ratio to either the Utidelone plus AC group or the docetaxel plus AC group stratified by hormone receptor status ER andor PgR positive vs ER and PgR negative
Detailed Description:
The subjects in treatment group will be treated with Utidelone at 30 mgm2d administered intravenously once daily on days 1-5 of each cycle and doxorubicin at 50mgm2 and cyclophosphamide at 500 mgm2 administered intravenously once daily on day 1 of each cycle One treatment cycle has 21 days and there are in total 6 cycles The subjects in control group will be treated with docetaxel at 75 mgm2 doxorubicin at 50 mgm2 and cyclophosphamide at 500mgm2 administered intravenously once on day 1 of each cycle One cycle has 21 days and there are 6 cycles in total
After the neoadjuvant therapy all patients suitable for surgery should take the operation and patients will be evaluated pre-operatively for clinical remission according to RECIST 11 After the surgery patients will be evaluated for pathological remission and physicians will recommend according to clinical practice guidelines and clinical practice at each site radiotherapy or adjuvant therapy for patients with corresponding clinical indications and endocrine therapy for ER positive andor PgR positive patients Patients unsuitable for surgery receive other treatments according to the clinical practice at each site
Safety evaluation will be performed 28 days after the last dose and patients will be followed up for at least 3 years for disease recurrence
After the neoadjuvant therapy all patients suitable for surgery should take the operation and patients will be evaluated pre-operatively for clinical remission according to RECIST 11 After the surgery patients will be evaluated for pathological remission and physicians will recommend according to clinical practice guidelines and clinical practice at each site radiotherapy or adjuvant therapy for patients with corresponding clinical indications and endocrine therapy for ER positive andor PgR positive patients Patients unsuitable for surgery receive other treatments according to the clinical practice at each site
Safety evaluation will be performed 28 days after the last dose and patients will be followed up for at least 3 years for disease recurrence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None