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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by King Faisal Specialist Hospital & Research Center.
Recruitment status was  Active, not recruiting
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: April 16, 2012
Last verified: April 2012
  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

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 ]

Estimated Enrollment: 285
Study Start Date: June 2007
Estimated Study Completion Date: June 2013
Estimated 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
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: April 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Trastuzumab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014