Phase II Study of Neoadjuvant Chemotherapy With Doxorubic... | NCT00538525

Studies
Phase II Study of Neoadjuvant Chemotherapy With Doxorubicin Followed by Docetaxel-Cisplatin in Locally Advanced Breast Cancer

NCT00538525

Sponsor

King Faisal Specialist Hospital & Research Center

Status

Completed

Last Update Posted

May 30, 2012Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Doxorubicin, Docetaxel, Cisplatin

Countries

Not provided

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

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Oct 1, 2007

First Submission Date that Met QC Criteria

Oct 1, 2007

First Posted Date

Oct 2, 2007Estimated

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

May 26, 2012

Last Update Posted Date

May 30, 2012Estimated

Description Module

Brief Summary

Phase II study of neoadjuvant chemotherapy with Doxorubicin followed by Docetaxel-Cisplatin in locally advanced breast cancer

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Active Comparator	Doxorubicin, Docetaxel, Cisplatin	Drug: Doxorubicin, Docetaxel, Cisplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doxorubicin, Docetaxel, Cisplatin	Drug	Doxorubicin, Docetaxel, Cisplatin	Arm 1

Measure	Description	Time Frame
Effectiveness		overall

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with locally advanced breast cancer

Exclusion Criteria:

Patients with metastatic breast cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adnan Ezzat, MD	KFSH&RC, Riyadh, Saudi Arabia	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

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
D004317	Doxorubicin
D000077143	Docetaxel
D002945	Cisplatin

Ancestor Terms

ID	Term
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided