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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

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ClinicalTrials.gov Identifier: NCT00535509
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Naeem A. Chaudhri, King Faisal Specialist Hospital & Research Center

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

Condition or disease Intervention/treatment
Breast Cancer Radiation: Cisplatin-Docetaxel ± Trastuzumab Other: Cisplatin-Docetaxel ± Trastuzumab Drug: Cisplatin-Docetaxel ± Trastuzumab

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Neoadjuvant[FEC100]/Cisplatin-Docetaxel ± Trastuzumab in Women With Over Expressed or Amplified Her2/Neu With Locally Advanced Breast Cancer
Study Start Date : June 2007
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources


Intervention Details:
    Radiation: Cisplatin-Docetaxel ± Trastuzumab
    Chemo & RT
    Other: Cisplatin-Docetaxel ± Trastuzumab
    Chemo & RT
    Drug: Cisplatin-Docetaxel ± Trastuzumab
    Chemo & RT


Primary Outcome Measures :
  1. Efficacy [ Time Frame: overall ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with locally advanced breast cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535509


Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Taher Twegieri, MD KFSH&RC
Study Director: Dahish Ajarim, MD KFSH&RC

Responsible Party: Dr. Naeem A. Chaudhri, Principal Investigator, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT00535509     History of Changes
Other Study ID Numbers: RAC #2061-048
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Cisplatin
Trastuzumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action