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Phase II Trial of Neoadjuvant[FEC100]/Cisplatin-Docetaxel ± Trastuzumab in Women With Over Expressed or Amplified Her2/Neu With Locally Advanced Breast Cancer

NCT ID: NCT00535509

Last Updated: 2015-12-17

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

COMPLETED

Clinical Phase

NA

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2013-06-30

Brief Summary

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Phase II trial of Neoadjuvant \[FEC100\]/Cisplatin-Docetaxel ± Trastuzumab in women with over expressed or amplified Her2/Neu with Locally advanced Breast Cancer

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cisplatin-Docetaxel ± Trastuzumab

Chemo \& RT

Intervention Type RADIATION

Cisplatin-Docetaxel ± Trastuzumab

Chemo \& RT

Intervention Type OTHER

Cisplatin-Docetaxel ± Trastuzumab

Chemo \& RT

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with locally advanced breast cancer
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role lead

Responsible Party

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Dr. Naeem A. Chaudhri

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Taher Twegieri, MD

Role: PRINCIPAL_INVESTIGATOR

KFSH&RC

Dahish Ajarim, MD

Role: STUDY_DIRECTOR

KFSH&RC

Other Identifiers

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RAC #2061-048

Identifier Type: -

Identifier Source: org_study_id