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Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00182793
First received: September 15, 2005
Last updated: January 31, 2017
Last verified: January 2017
Results First Received: January 31, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Biological: trastuzumab
Drug: carboplatin
Drug: cyclophosphamide
Drug: melphalan
Drug: thiotepa
Procedure: adjuvant therapy
Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
Procedure: bone marrow ablation with stem cell support
Radiation: radiation therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Patients Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.

Participant Flow:   Overall Study
    All Patients
STARTED   32 
COMPLETED   32 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
All Patients Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.

Baseline Measures
   All Patients 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Years]
Median (Full Range)
 47 
 (32 to 66) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      32 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   32 


  Outcome Measures
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1.  Primary:   5-Year Relapse-free Survival Rate   [ Time Frame: From time of initial PBPC rescue until death or disease recurrence (disease progression for patients with stage IV disease), whichever came first, up to 5 years post treatment ]

2.  Primary:   5-Year Overall Survival Rate   [ Time Frame: From time of initial PBPC rescue until the date of death from any cause, assessed up to 5 years post treatment. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Paul Frankel, Ph.D.
Organization: City of Hope
phone: 626-359-8111 ext 65265
e-mail: pfrankel@coh.org



Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00182793     History of Changes
Other Study ID Numbers: 05042
P30CA033572 ( US NIH Grant/Contract Award Number )
CDR0000442105 ( Registry Identifier: PDQ )
Study First Received: September 15, 2005
Results First Received: January 31, 2017
Last Updated: January 31, 2017