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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Naeem A. Chaudhri, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT00535509
First received: September 24, 2007
Last updated: December 16, 2015
Last verified: December 2015
  Purpose
Phase II trial of Neoadjuvant [FEC100]/Cisplatin-Docetaxel ± Trastuzumab in women with over expressed or amplified Her2/Neu with Locally advanced Breast Cancer

Condition Intervention
Breast Cancer
Radiation: Cisplatin-Docetaxel ± Trastuzumab
Other: Cisplatin-Docetaxel ± Trastuzumab
Drug: Cisplatin-Docetaxel ± Trastuzumab

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: overall ] [ Designated as safety issue: No ]

Enrollment: 285
Study Start Date: June 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Cisplatin-Docetaxel ± Trastuzumab
    Chemo & RT
    Other: Cisplatin-Docetaxel ± Trastuzumab
    Chemo & RT
    Drug: Cisplatin-Docetaxel ± Trastuzumab
    Chemo & RT
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with locally advanced breast cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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 
Study First Received: September 24, 2007
Last Updated: December 16, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cisplatin
Docetaxel
Trastuzumab
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on February 10, 2016