NCT00538525

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2007

Shorter than P25 for not_applicable breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

7 months

First QC Date

October 1, 2007

Last Update Submit

May 26, 2012

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Effectiveness

    overall

Study Arms (1)

Arm 1

ACTIVE COMPARATOR

Doxorubicin, Docetaxel, Cisplatin

Drug: Doxorubicin, Docetaxel, Cisplatin

Interventions

Doxorubicin, Docetaxel, CisplatinDRUG

Doxorubicin, Docetaxel, Cisplatin

Arm 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with locally advanced breast cancer

You may not qualify if:

  • Patients with metastatic breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DoxorubicinDocetaxelCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Adnan Ezzat, MD

    KFSH&RC, Riyadh, Saudi Arabia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2007

First Posted

October 2, 2007

Study Start

September 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

May 30, 2012

Record last verified: 2012-05