First-line Gemcitabine Plus Cisplatin in Locally Advanced (IIIC Stage) Breast Cancer Patients

Phase 2

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Doxorubicin; Drug: Cisplatin; Drug: Cyclophosphamide; Drug: Gemcitabine; Drug: Paclitaxel

• Registration Number: NCT06531447
• Lead Sponsor: The National Center of Oncology, Azerbaijan

Brief 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2017-11
• Status Verified: 2024-04
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

IIIC stage breast cancer patients

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Exclusion Criteria

Other stages breast cancer patients

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Paclitaxel	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.
Control group	Doxorubicin	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.
Control group	Cyclophosphamide	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.
Experimental group	Cisplatin	1250 mg/m2 Gemcitabine 1st and 8th days of 6 cycles and 75mg/m2 Cisplatine 1st day every 3 weeks of 6 cycles
Experimental group	Gemcitabine	1250 mg/m2 Gemcitabine 1st and 8th days of 6 cycles and 75mg/m2 Cisplatine 1st day every 3 weeks of 6 cycles

Primary Outcome Measures

Name	Time	Method
Clinical tumor regression rate	4 months	Chemotherapy combination Gemcitabine with Cisplatin

Secondary Outcome Measures

Name	Time	Method
Increasing PFS and OS	5 years and 10 years	Observation after chemotherapy

Trial Locations

Locations (1)

Elchin Mansurov; 🇦🇿 Baku, Azerbaijan