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

NCT ID: NCT06531447

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2027-05-31

Brief Summary

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

Detailed Description

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

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Doxorubicin

Intervention Type DRUG

Every 21 days 4 cycles

Cyclophosphamide

Intervention Type DRUG

Every 21 days 4 cycles

Paclitaxel

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

Every 21 days 6 cycles

Gemcitabine

Intervention Type DRUG

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

Interventions

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Cisplatin

Every 21 days 6 cycles

Intervention Type DRUG

Gemcitabine

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

Intervention Type DRUG

Doxorubicin

Every 21 days 4 cycles

Intervention Type DRUG

Cyclophosphamide

Every 21 days 4 cycles

Intervention Type DRUG

Paclitaxel

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

Intervention Type DRUG

Other Intervention Names

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CDDP Gemcitabine hydrochlorid

Eligibility Criteria

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Inclusion Criteria

IIIC stage breast cancer patients

Exclusion Criteria

Other stages breast cancer patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The National Center of Oncology, Azerbaijan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Elchin Mansurov

Head of the Chemothrapy II

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elchin Mansurov, PhD

Role: PRINCIPAL_INVESTIGATOR

The National Center of Oncology

Locations

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Elchin Mansurov

Baku, , Azerbaijan

Site Status

Countries

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Azerbaijan

Other Identifiers

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MOM-0004

Identifier Type: -

Identifier Source: org_study_id

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