Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2025-12-16 @ 10:00 PM
Study NCT ID:
NCT04677816
Status:
None
Last Update Posted:
2025-06-27 00:00:00
First Post:
2020-12-15 00:00:00
Brief Title:
Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients Receiving Neoadjuvant Chemotherapy for Operable Triple Negative Breast Cancer
Status:
None
Status Verified Date:
2025-06
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:
Primary Objective: To determine if pathologic complete response in vitamin D deficient patients receiving vitamin D supplementation during neoadjuvant chemotherapy for operable triple negative breast cancer is greater than or equal to 60% or less than or equal to pathologic complete response in historical controls (30%) using a one-stage phase II design.
Secondary Objective(s):
* To estimate the proportion of patients with residual cancer burden (RCB) classes I, II, and III in vitamin D deficient patients receiving vitamin D supplementation during neoadjuvant chemotherapy for operable triple negative breast cancer.
* To estimate pathologic complete response reaction in the observational arm of vitamin D sufficient patients receiving neoadjuvant chemotherapy for operable triple negative breast cancer.
* To determine the feasibility of delivery of vitamin D supplementation with standard of care chemotherapy.
* To determine the safety and tolerability of the combination of vitamin D supplementation with standard of care chemotherapy.
* To estimate the change in vitamin D receptor (VDR) expression from pre- and post-neoadjuvant treatment breast tumor tissue samples of vitamin D deficient patients.
* To estimate the change in VDR expression from pre- to post-neoadjuvant treatment breast tumor tissue samples in a sample of 5 vitamin D sufficient patients.
* To estimate the changes in the fecal microbiome and mammary gland microbiome of vitamin D deficient patients from pre- to post-neoadjuvant treatment, and to explore the concordance in the changes between the mammary and fecal microbiome.
* To estimate the changes in the fecal microbiome and mammary gland microbiome in a sample of 5 vitamin D sufficient patients from pre- to post-neoadjuvant treatment.
Patients will be followed for a minimum of 30 days after the last study intervention is administered for adverse events monitoring.
Patients will be followed for 30 days after removal from study or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Secondary Objective(s):
* To estimate the proportion of patients with residual cancer burden (RCB) classes I, II, and III in vitamin D deficient patients receiving vitamin D supplementation during neoadjuvant chemotherapy for operable triple negative breast cancer.
* To estimate pathologic complete response reaction in the observational arm of vitamin D sufficient patients receiving neoadjuvant chemotherapy for operable triple negative breast cancer.
* To determine the feasibility of delivery of vitamin D supplementation with standard of care chemotherapy.
* To determine the safety and tolerability of the combination of vitamin D supplementation with standard of care chemotherapy.
* To estimate the change in vitamin D receptor (VDR) expression from pre- and post-neoadjuvant treatment breast tumor tissue samples of vitamin D deficient patients.
* To estimate the change in VDR expression from pre- to post-neoadjuvant treatment breast tumor tissue samples in a sample of 5 vitamin D sufficient patients.
* To estimate the changes in the fecal microbiome and mammary gland microbiome of vitamin D deficient patients from pre- to post-neoadjuvant treatment, and to explore the concordance in the changes between the mammary and fecal microbiome.
* To estimate the changes in the fecal microbiome and mammary gland microbiome in a sample of 5 vitamin D sufficient patients from pre- to post-neoadjuvant treatment.
Patients will be followed for a minimum of 30 days after the last study intervention is administered for adverse events monitoring.
Patients will be followed for 30 days after removal from study or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Detailed Description:
Primary Objective To determine if pathologic complete response in vitamin D deficient patients receiving vitamin D supplementation during neoadjuvant chemotherapy for operable triple negative breast cancer is greater than or equal to 60 or less than or equal to pathologic complete response in historical controls 30 using a one-stage phase II design
Secondary Objectives
To estimate the proportion of patients with residual cancer burden RCB classes I II and III in vitamin D deficient patients receiving vitamin D supplementation during neoadjuvant chemotherapy for operable triple negative breast cancer
To estimate pathologic complete response reaction in the observational arm of vitamin D sufficient patients receiving neoadjuvant chemotherapy for operable triple negative breast cancer
To determine the feasibility of delivery of vitamin D supplementation with standard of care chemotherapy
To determine the safety and tolerability of the combination of vitamin D supplementation with standard of care chemotherapy
To estimate the change in vitamin D receptor VDR expression from pre- and post-neoadjuvant treatment breast tumor tissue samples of vitamin D deficient patients
To estimate the change in VDR expression from pre- to post-neoadjuvant treatment breast tumor tissue samples in a sample of 5 vitamin D sufficient patients
To estimate the changes in the fecal microbiome and mammary gland microbiome of vitamin D deficient patients from pre- to post-neoadjuvant treatment and to explore the concordance in the changes between the mammary and fecal microbiome
To estimate the changes in the fecal microbiome and mammary gland microbiome in a sample of 5 vitamin D sufficient patients from pre- to post-neoadjuvant treatment
Patients will be followed for a minimum of 30 days after the last study intervention is administered for adverse events monitoring
Patients will be followed for 30 days after removal from study or until death whichever occurs first Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event
Secondary Objectives
To estimate the proportion of patients with residual cancer burden RCB classes I II and III in vitamin D deficient patients receiving vitamin D supplementation during neoadjuvant chemotherapy for operable triple negative breast cancer
To estimate pathologic complete response reaction in the observational arm of vitamin D sufficient patients receiving neoadjuvant chemotherapy for operable triple negative breast cancer
To determine the feasibility of delivery of vitamin D supplementation with standard of care chemotherapy
To determine the safety and tolerability of the combination of vitamin D supplementation with standard of care chemotherapy
To estimate the change in vitamin D receptor VDR expression from pre- and post-neoadjuvant treatment breast tumor tissue samples of vitamin D deficient patients
To estimate the change in VDR expression from pre- to post-neoadjuvant treatment breast tumor tissue samples in a sample of 5 vitamin D sufficient patients
To estimate the changes in the fecal microbiome and mammary gland microbiome of vitamin D deficient patients from pre- to post-neoadjuvant treatment and to explore the concordance in the changes between the mammary and fecal microbiome
To estimate the changes in the fecal microbiome and mammary gland microbiome in a sample of 5 vitamin D sufficient patients from pre- to post-neoadjuvant treatment
Patients will be followed for a minimum of 30 days after the last study intervention is administered for adverse events monitoring
Patients will be followed for 30 days after removal from study or until death whichever occurs first Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA012197 | NIH | Wake Forest Baptist Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA012197 |
| WFBCCC 98121 | OTHER | None | None |