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A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Washington University School of Medicine
St Louis, Missouri, United States
Start Date
July 7, 2014
Primary Completion Date
November 10, 2021
Completion Date
December 31, 2021
Last Updated
November 7, 2022
148
ACTUAL participants
Docetaxel
DRUG
Carboplatin
DRUG
FDG-PET/MR
PROCEDURE
Lead Sponsor
Washington University School of Medicine
Collaborators
NCT05973864
NCT03742102
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03997123