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

NCT06531447 | Active Not Recruiting Phase 2

• 1 other identifier: MOM-0004
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to investigate of the prognostics and predictive role of TUBB3 expression in locally advanced breast cancer

Conditions

Breast Cancer

Keywords

Breast cancer; TUBB3 gene; ERCC1 gene; RMM1 gene; Prognosis and predictive

Outcome Measures

Primary Outcomes (1)

• Clinical tumor regression rate

  Chemotherapy combination Gemcitabine with Cisplatin

  4 months

Secondary Outcomes (1)

• Increasing PFS and OS

  5 years and 10 years

Study Arms (2)

Control group

ACTIVE COMPARATOR

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; Drug: Cyclophosphamide; Drug: Paclitaxel

Experimental group

ACTIVE COMPARATOR

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; Drug: Gemcitabine

Interventions

Cisplatin DRUG

Every 21 days 6 cycles

Also known as: CDDP

Experimental group

Gemcitabine DRUG

Every 21 days (First and 8th days) 6 cycles

Also known as: Gemcitabine hydrochlorid

Experimental group

Doxorubicin DRUG

Every 21 days 4 cycles

Control group

Cyclophosphamide DRUG

Every 21 days 4 cycles

Control group

Paclitaxel DRUG

Every 21 days 4 cycles or once a week for 12 weeks

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IIIC stage breast cancer patients

You may not qualify if:

• Other stages breast cancer patients

Sponsors & Collaborators

• The National Center of Oncology, Azerbaijan: lead

Study Sites (1)

Elchin Mansurov

Baku, AZ1011, Azerbaijan

Location

MeSH Terms

Conditions

Breast Neoplasms; Fibrosis Of Extraocular Muscles, Congenital, 3A, with or without Extraocular Involvement

Interventions

Cisplatin; Gemcitabine; Doxorubicin; Cyclophosphamide; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Elchin Mansurov, PhD

  The National Center of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Chemothrapy II

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: August 1, 2024
• Study Start: May 1, 2014
• Primary Completion: November 1, 2017
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available from 2022
• Access Criteria: Breast cancer specialists

Locations

AZ (1)