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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06531447
Enrollment
200
Registered
2024-08-01
Start date
2014-05-31
Completion date
2027-05-31
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

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

Interventions

DRUGCisplatin

Every 21 days 6 cycles

DRUGGemcitabine

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

DRUGDoxorubicin

Every 21 days 4 cycles

DRUGCyclophosphamide

Every 21 days 4 cycles

DRUGPaclitaxel

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

Sponsors

The National Center of Oncology, Azerbaijan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

IIIC stage breast cancer patients

Exclusion criteria

Other stages breast cancer patients

Design outcomes

Primary

MeasureTime frameDescription
Clinical tumor regression rate4 monthsChemotherapy combination Gemcitabine with Cisplatin

Secondary

MeasureTime frameDescription
Increasing PFS and OS5 years and 10 yearsObservation after chemotherapy

Countries

Azerbaijan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026