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Trial Title:
First-line Gemcitabine Plus Cisplatin in Locally Advanced (IIIC Stage) Breast Cancer Patients
NCT ID:
NCT06531447
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Cyclophosphamide
Gemcitabine
Doxorubicin
Conditions: Keywords:
Breast cancer
TUBB3 gene
ERCC1 gene
RMM1 gene
Prognosis and predictive
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Every 21 days 6 cycles
Arm group label:
Experimental group
Other name:
CDDP
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Every 21 days (First and 8th days) 6 cycles
Arm group label:
Experimental group
Other name:
Gemcitabine hydrochlorid
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
Every 21 days 4 cycles
Arm group label:
Control group
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Every 21 days 4 cycles
Arm group label:
Control group
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Every 21 days 4 cycles or once a week for 12 weeks
Arm group label:
Control group
Summary:
The goal of the study is to investigate of the prognostics and predictive role of TUBB3
expression in locally advanced breast cancer
Detailed description:
Using combination of gemcitabine plus cisplatine as first line treatment patients with
locally advanced breast cancer with high TUBB3 expression
Criteria for eligibility:
Criteria:
Inclusion Criteria:
IIIC stage breast cancer patients
Exclusion Criteria:
Other stages breast cancer patients
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Elchin Mansurov
Address:
City:
Baku
Zip:
AZ1011
Country:
Azerbaijan
Start date:
May 2014
Completion date:
May 2027
Lead sponsor:
Agency:
The National Center of Oncology, Azerbaijan
Agency class:
Other
Source:
The National Center of Oncology, Azerbaijan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06531447
