First-line Gemcitabine Plus Cisplatin in Locally Advanced (IIIC Stage) Breast Cancer Patients
NCT ID: NCT06531447
Last Updated: 2024-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2014-05-31
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
Doxorubicin 60mg/m2(Adriblastin) plus Cyclophosphamide 600mg/m2 (endoxan) IV, on 1st days every 3 weeks of 4 cycles. Paclitaxel (Taxol) 80mg/m2, IV every week of 12 cycles or 175mg/m2, IV, on 1st days every 3 weeks of 4 cycles.
Doxorubicin
Every 21 days 4 cycles
Cyclophosphamide
Every 21 days 4 cycles
Paclitaxel
Every 21 days 4 cycles or once a week for 12 weeks
Experimental group
1250 mg/m2 Gemcitabine 1st and 8th days of 6 cycles and 75mg/m2 Cisplatine 1st day every 3 weeks of 6 cycles
Cisplatin
Every 21 days 6 cycles
Gemcitabine
Every 21 days (First and 8th days) 6 cycles
Interventions
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Cisplatin
Every 21 days 6 cycles
Gemcitabine
Every 21 days (First and 8th days) 6 cycles
Doxorubicin
Every 21 days 4 cycles
Cyclophosphamide
Every 21 days 4 cycles
Paclitaxel
Every 21 days 4 cycles or once a week for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
FEMALE
No
Sponsors
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The National Center of Oncology, Azerbaijan
OTHER_GOV
Responsible Party
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Elchin Mansurov
Head of the Chemothrapy II
Principal Investigators
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Elchin Mansurov, PhD
Role: PRINCIPAL_INVESTIGATOR
The National Center of Oncology
Locations
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Elchin Mansurov
Baku, , Azerbaijan
Countries
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Other Identifiers
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MOM-0004
Identifier Type: -
Identifier Source: org_study_id
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