Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642428
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-13
Brief Title:
Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients With Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients With Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized controlled Phase III trial was designed to evaluate the impact of supplemental vitamin D VD on the efficacy and side effects of neoadjuvant therapy in patients with breast cancer
Detailed Description:
This is a parallel-group open-label randomized controlled trial designed to investigate the effects of supplemental vitamin D VD on the outcomes and side effects of neoadjuvant therapy in patients with breast cancer Both groups will receive standard neoadjuvant therapy on day 1 and for each subsequent cycle Additionally vitamin D2 will be randomly administered to both groupsBlood samples and imaging results will be collected and analyzed prior to the initiation of neoadjuvant therapy and after every two cycles Key outcomes to be recorded include the pathological complete response rate pCR objective response rate ORR disease control rate DCR and grade III or higher adverse effects related to neoadjuvant therapy The primary and secondary study findings along with adverse events will be thoroughly evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None