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

The National Center of Oncology, Azerbaijan

Status and phase: Active, not recruiting; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Gemcitabine; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Cisplatin; Drug: Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT06531447

MOM-0004

Details and patient eligibility

About

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

Full description

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

Enrollment: 200 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

IIIC stage breast cancer patients

Exclusion criteria

Other stages breast cancer patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Drug: Paclitaxel

Drug: Cyclophosphamide

Drug: Doxorubicin

Experimental group

Active Comparator group

Description:

1250 mg/m2 Gemcitabine 1st and 8th days of 6 cycles and 75mg/m2 Cisplatine 1st day every 3 weeks of 6 cycles

Treatment:

Drug: Cisplatin

Drug: Gemcitabine