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Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer

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ClinicalTrials.gov Identifier: NCT00118053
Recruitment Status : Terminated (slow accrual)
First Posted : July 11, 2005
Results First Posted : November 20, 2013
Last Update Posted : November 20, 2013
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Biological: herceptin
Drug: carboplatin
Drug: docetaxel
Procedure: conventional surgery
Procedure: radiation therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) and 3 community hospitals within NJ from March 2005 through January 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Docetaxel, Carboplatin and Trastuzumab

A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.

  • Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.
  • If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks.

Participant Flow:   Overall Study
    Docetaxel, Carboplatin and Trastuzumab
STARTED   5 
COMPLETED   5 
NOT COMPLETED   0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Docetaxel, Carboplatin and Trastuzumab

A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.

  • Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.
  • If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks.

Baseline Measures
   Docetaxel, Carboplatin and Trastuzumab 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   5 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.4  (9.9) 
Gender 
[Units: Participants]
 
Female   5 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   5 


  Outcome Measures

1.  Primary:   Antitumor Activity as Measured by Response Rate   [ Time Frame: 5 years ]

2.  Secondary:   Pathological Complete Response   [ Time Frame: 5 years ]

3.  Secondary:   Disease-free Survival   [ Time Frame: 10 years ]

4.  Secondary:   Pathologic and Molecular Markers for Predicting Efficacy   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Deborah Toppmeyer, MD
Organization: Cancer Institute of New Jersey
phone: 732-235-8675
e-mail: toppmede@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu



Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00118053     History of Changes
Other Study ID Numbers: 040412;CDR0000433511
P30CA072720 ( U.S. NIH Grant/Contract )
CINJ-040412 ( Other Identifier: Cancer Institute of New Jersey )
0220045191 ( Other Identifier: UMDNJ-RWJMS IRB )
CINJ-NJ1104 ( Other Identifier: Cancer Institute of New Jersey )
First Submitted: July 8, 2005
First Posted: July 11, 2005
Results First Submitted: September 17, 2013
Results First Posted: November 20, 2013
Last Update Posted: November 20, 2013