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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
Enrollment 5
Recruitment Details 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  
Arm/Group Title Docetaxel, Carboplatin and Trastuzumab
Hide Arm/Group Description

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.
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Docetaxel, Carboplatin and Trastuzumab
Hide Arm/Group Description

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.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
46.4  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Antitumor Activity as Measured by Response Rate
Hide Description [Not Specified]
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early and insufficient data were collected to evaluate this outcome measure.
Arm/Group Title Docetaxel, Carboplatin and Trastuzumab
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Pathological Complete Response
Hide Description [Not Specified]
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early and insufficient data were collected to evaluate this outcome measure.
Arm/Group Title Docetaxel, Carboplatin and Trastuzumab
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Disease-free Survival
Hide Description [Not Specified]
Time Frame 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early and insufficient data were collected to evaluate this outcome measure.
Arm/Group Title Docetaxel, Carboplatin and Trastuzumab
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Pathologic and Molecular Markers for Predicting Efficacy
Hide Description [Not Specified]
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early and insufficient data were collected to evaluate this outcome measure.
Arm/Group Title Docetaxel, Carboplatin and Trastuzumab
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Docetaxel, Carboplatin and Trastuzumab
Hide Arm/Group Description

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.
All-Cause Mortality
Docetaxel, Carboplatin and Trastuzumab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Docetaxel, Carboplatin and Trastuzumab
Affected / at Risk (%) # Events
Total   1/5 (20.00%)    
Gastrointestinal disorders   
Diarrhea * 1  1/5 (20.00%)  1
General disorders   
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1  1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Docetaxel, Carboplatin and Trastuzumab
Affected / at Risk (%) # Events
Total   4/5 (80.00%)    
Blood and lymphatic system disorders   
Neutrophils/granulocytes (ANC/AGC) * 1  2/5 (40.00%)  4
Blood/Bone Marrow - Other (Specify, __) * 1  1/5 (20.00%)  1
Hemoglobin * 1  1/5 (20.00%)  3
Leukocytes (total WBC) * 1  1/5 (20.00%)  4
Eye disorders   
Eyelid dysfunction * 1  1/5 (20.00%)  1
Gastrointestinal disorders   
Diarrhea * 1  2/5 (40.00%)  3
Constipation * 1  1/5 (20.00%)  1
Mucositis/stomatitis (clinical exam) - Oral cavity * 1  1/5 (20.00%)  1
Nausea * 1  1/5 (20.00%)  3
Vomiting * 1  1/5 (20.00%)  1
General disorders   
Fatigue (asthenia, lethargy, malaise) * 1  4/5 (80.00%)  7
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) * 1  1/5 (20.00%)  1
Pain - Extremity-limb * 1  2/5 (40.00%)  2
Pain - Abdomen NOS * 1  1/5 (20.00%)  1
Pain - Other (Specify, __) * 1  1/5 (20.00%)  1
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1  1/5 (20.00%)  1
Infections and infestations   
Infection with unknown ANC - Bladder (urinary) * 1  1/5 (20.00%)  1
Infection with unknown ANC - Urinary tract NOS * 1  1/5 (20.00%)  1
Investigations   
Glucose, serum-high (hyperglycemia) * 1  2/5 (40.00%)  6
ALT, SGPT (serum glutamic pyruvic transaminase) * 1  1/5 (20.00%)  6
AST, SGOT(serum glutamic oxaloacetic transaminase) * 1  1/5 (20.00%)  5
Potassium, serum-low (hypokalemia) * 1  1/5 (20.00%)  2
Sodium, serum-low (hyponatremia) * 1  1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized * 1  1/5 (20.00%)  1
Nervous system disorders   
Neurology - Other (Specify, __) * 1  1/5 (20.00%)  1
Neuropathy: sensory * 1  1/5 (20.00%)  5
Skin and subcutaneous tissue disorders   
Hair loss/alopecia (scalp or body) * 1  2/5 (40.00%)  3
Bruising (in absence of Grade 3 or 4 thrombocytopenia) * 1  1/5 (20.00%)  2
Rash: acne/acneiform * 1  1/5 (20.00%)  2
Vascular disorders   
Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic synd * 1  1/5 (20.00%)  2
Edema: limb * 1  1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
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