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

July 29, 2024 updated by: Elchin Mansurov, The National Center of Oncology, Azerbaijan
The goal of the study is to investigate of the prognostics and predictive role of TUBB3 expression in locally advanced breast cancer

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Using combination of gemcitabine plus cisplatine as first line treatment patients with locally advanced breast cancer with high TUBB3 expression

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Azerbaijan
      • Baku, Azerbaijan, AZ1011
        • Elchin Mansurov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

IIIC stage breast cancer patients

Exclusion Criteria:

Other stages breast cancer patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Doxorubicin
Every 21 days 4 cycles
Drug: Cyclophosphamide
Every 21 days 4 cycles
Drug: Paclitaxel
Every 21 days 4 cycles or once a week for 12 weeks
Active Comparator: 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
Drug: Cisplatin
Every 21 days 6 cycles
Other Names:
  • CDDP
Drug: Gemcitabine
Every 21 days (First and 8th days) 6 cycles
Other Names:
  • Gemcitabine hydrochlorid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical tumor regression rate
Time Frame: 4 months
Chemotherapy combination Gemcitabine with Cisplatin
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increasing PFS and OS
Time Frame: 5 years and 10 years
Observation after chemotherapy
5 years and 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The National Center of Oncology, Azerbaijan

Investigators

  • Principal Investigator: Elchin Mansurov, PhD, The National Center of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

November 1, 2017

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOM-0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Available from 2022

IPD Sharing Access Criteria

Breast cancer specialists

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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