Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535893
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sustainable and Efficient Platform of New Therapeutic Development for Early Breast Cancer S-FACT
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Randomized phase II trial targeting early-stage breast cancer stage II-III applicable to preoperative chemotherapy NAC comparing standard treatment with multiple experimental treatments
Detailed Description:
This randomized phase II trial targets early-stage breast cancer stage II-III with preoperative chemotherapy NAC It compares standard treatment with multiple experimental treatments using an adaptive design allowing new treatments to be added during or after the trial Patients are classified by subtype and randomized between standard and experimental treatments
The trial is flexible permitting single or combination new drug therapies and incorporating circulating tumor DNA ctDNA evaluation for precise efficacy and prognosis prediction
The trial is flexible permitting single or combination new drug therapies and incorporating circulating tumor DNA ctDNA evaluation for precise efficacy and prognosis prediction
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