Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-29 @ 4:41 AM
Study NCT ID:
NCT02124902
Status:
TERMINATED
Last Update Posted:
2022-11-07
First Post:
2014-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neoadjuvant Treatment of Triple Negative Breast Cancer Patients With Docetaxel and Carboplatin to Assess Anti-tumor Activity
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient funding/staff
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single arm open label phase II study in women with clinical stage 2 or 3 triple negative breast cancer to assess the anti-tumor activity (in terms of pathologic complete response rate) of neoadjuvant docetaxel in combination with carboplatin. Patient derived xenografts will also be developed simultaneously for the purposes of genoproteomic analysis.
Please note that Baylor College of Medicine (BCM) has a parallel study the same as this study. Baylor is expected to enroll approximately 19 participants that have complied with the inclusion and exclusion criteria for this study (excluded participants from BCM will include male participants or participants with inflammatory breast cancer). The investigators will pool participants and data from the BCM study and the study at Washington University School of Medicine. Pooling the data will potentially improve statistical power.
Please note that Baylor College of Medicine (BCM) has a parallel study the same as this study. Baylor is expected to enroll approximately 19 participants that have complied with the inclusion and exclusion criteria for this study (excluded participants from BCM will include male participants or participants with inflammatory breast cancer). The investigators will pool participants and data from the BCM study and the study at Washington University School of Medicine. Pooling the data will potentially improve statistical power.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1U24CA209837-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |