First-line Gemcitabine Plus Cisplatin in Locally Advanced... | NCT06531447

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

NCT06531447

Sponsor

The National Center of Oncology, Azerbaijan

Status

Active, not recruiting

Last Update Posted

Aug 1, 2024Actual

Enrollment

200Actual

Phase

Phase 2

Conditions

Breast Cancer

Interventions

Cisplatin
Gemcitabine
Doxorubicin
Cyclophosphamide
Paclitaxel

Countries

Azerbaijan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Nov 2017Actual

Completion Date

May 2027Estimated

First Submitted Date

Apr 8, 2024

First Submission Date that Met QC Criteria

Jul 29, 2024

First Posted Date

Aug 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2024

Last Update Posted Date

Aug 1, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elchin Mansurov, Head of the Chemothrapy II, The National Center of Oncology, AzerbaijanPrincipal Investigator

Lead Sponsor

The National Center of Oncology, AzerbaijanOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cisplatin	Drug	Every 21 days 6 cycles	Experimental group	CDDP

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

IIIC stage breast cancer patients

Exclusion Criteria:

Other stages breast cancer patients

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elchin Mansurov, PhD	The National Center of Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Elchin Mansurov		Baku		AZ1011	Azerbaijan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol

Time Frame

Available from 2022

Access Criteria

Breast cancer specialists

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
C567572	Fibrosis Of Extraocular Muscles, Congenital, 3A, with or without Extraocular Involvement

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002945	Cisplatin
D000093542	Gemcitabine
D004317	Doxorubicin
D003520	Cyclophosphamide
D017239	Paclitaxel

Ancestor Terms

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

Browse Leaves

Not provided

Browse Branches

Not provided