Trial Outcomes & Findings for Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer (NCT NCT00118053)
NCT ID: NCT00118053
Last Updated: 2013-11-20
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
5 years
Results posted on
2013-11-20
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel, Carboplatin and Trastuzumab
n=5 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
46.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Study was terminated early and insufficient data were collected to evaluate this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: Study was terminated early and insufficient data were collected to evaluate this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 yearsPopulation: Study was terminated early and insufficient data were collected to evaluate this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: Study was terminated early and insufficient data were collected to evaluate this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Docetaxel, Carboplatin and Trastuzumab
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel, Carboplatin and Trastuzumab
n=5 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1 • 3 years
|
|
General disorders
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
20.0%
1/5 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Docetaxel, Carboplatin and Trastuzumab
n=5 participants at risk
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.
|
|---|---|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
80.0%
4/5 • Number of events 7 • 3 years
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
20.0%
1/5 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
40.0%
2/5 • Number of events 3 • 3 years
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
20.0%
1/5 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
20.0%
1/5 • Number of events 2 • 3 years
|
|
Investigations
Glucose, serum-high (hyperglycemia)
|
40.0%
2/5 • Number of events 6 • 3 years
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
20.0%
1/5 • Number of events 6 • 3 years
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
20.0%
1/5 • Number of events 5 • 3 years
|
|
Investigations
Potassium, serum-low (hypokalemia)
|
20.0%
1/5 • Number of events 2 • 3 years
|
|
Investigations
Sodium, serum-low (hyponatremia)
|
20.0%
1/5 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
40.0%
2/5 • Number of events 4 • 3 years
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Specify, __)
|
20.0%
1/5 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
20.0%
1/5 • Number of events 3 • 3 years
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
20.0%
1/5 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
20.0%
1/5 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • 3 years
|
|
General disorders
Pain - Extremity-limb
|
40.0%
2/5 • Number of events 2 • 3 years
|
|
General disorders
Pain - Abdomen NOS
|
20.0%
1/5 • Number of events 1 • 3 years
|
|
General disorders
Pain - Other (Specify, __)
|
20.0%
1/5 • Number of events 1 • 3 years
|
|
Vascular disorders
Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic synd
|
20.0%
1/5 • Number of events 2 • 3 years
|
|
General disorders
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
20.0%
1/5 • Number of events 1 • 3 years
|
|
Infections and infestations
Infection with unknown ANC - Bladder (urinary)
|
20.0%
1/5 • Number of events 1 • 3 years
|
|
Infections and infestations
Infection with unknown ANC - Urinary tract NOS
|
20.0%
1/5 • Number of events 1 • 3 years
|
|
Vascular disorders
Edema: limb
|
20.0%
1/5 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
20.0%
1/5 • Number of events 1 • 3 years
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
20.0%
1/5 • Number of events 1 • 3 years
|
|
Nervous system disorders
Neuropathy: sensory
|
20.0%
1/5 • Number of events 5 • 3 years
|
|
Eye disorders
Eyelid dysfunction
|
20.0%
1/5 • Number of events 1 • 3 years
|
Additional Information
Deborah Toppmeyer, MD
Cancer Institute of New Jersey
Phone: 732-235-8675
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place