Trial Outcomes & Findings for Docetaxel, Carboplatin, Trastuzumab, and Lapatinib in Treating Patients With Early Stage Breast Cancer (NCT NCT00820872)
NCT ID: NCT00820872
Last Updated: 2019-10-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 10 years
Results posted on
2019-10-21
Participant Flow
Participant milestones
| Measure |
Group 1
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Docetaxel, Carboplatin, Trastuzumab, and Lapatinib in Treating Patients With Early Stage Breast Cancer
Baseline characteristics by cohort
| Measure |
Group 1
n=30 Participants
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
|
|---|---|
|
Age, Continuous
|
54.5 Years
n=99 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 10 yearsPopulation: All evaulable patients
Outcome measures
| Measure |
Group 1
n=30 Participants
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
|
|---|---|
|
Proportion of Patients Experiencing Grade 3 or 4 Diarrhea as Measured by NCI CTCAE v3.0
|
43 percentage of patients
|
Adverse Events
Group 1
Serious events: 10 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=30 participants at risk
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
23.3%
7/30 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Fatigue
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Skin infection
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Platelet count decreased
|
10.0%
3/30 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
3.3%
1/30 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
2/30 • Number of events 2
|
Other adverse events
| Measure |
Group 1
n=30 participants at risk
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
90.0%
27/30 • Number of events 219
|
|
Blood and lymphatic system disorders
Hemolysis
|
3.3%
1/30 • Number of events 3
|
|
Cardiac disorders
Left ventricular dysfunction
|
10.0%
3/30 • Number of events 8
|
|
Cardiac disorders
Left ventricular failure
|
10.0%
3/30 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
10.0%
3/30 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhea
|
93.3%
28/30 • Number of events 180
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
46.7%
14/30 • Number of events 47
|
|
Gastrointestinal disorders
Flatulence
|
3.3%
1/30 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.3%
1/30 • Number of events 4
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
10/30 • Number of events 30
|
|
Gastrointestinal disorders
Nausea
|
80.0%
24/30 • Number of events 104
|
|
Gastrointestinal disorders
Vomiting
|
63.3%
19/30 • Number of events 38
|
|
General disorders
Edema limbs
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Fatigue
|
83.3%
25/30 • Number of events 195
|
|
Hepatobiliary disorders
Cholecystitis
|
3.3%
1/30 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
13.3%
4/30 • Number of events 11
|
|
Infections and infestations
Opportunistic infection
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Rhinitis infective
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Skin infection
|
3.3%
1/30 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
3.3%
1/30 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
53.3%
16/30 • Number of events 47
|
|
Investigations
Alkaline phosphatase increased
|
43.3%
13/30 • Number of events 58
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
12/30 • Number of events 40
|
|
Investigations
Bilirubin increased
|
16.7%
5/30 • Number of events 23
|
|
Investigations
Coagulopathy
|
3.3%
1/30 • Number of events 2
|
|
Investigations
Leukocyte count decreased
|
10.0%
3/30 • Number of events 10
|
|
Investigations
Lymphocyte count decreased
|
6.7%
2/30 • Number of events 13
|
|
Investigations
Neutrophil count decreased
|
56.7%
17/30 • Number of events 74
|
|
Investigations
Platelet count decreased
|
63.3%
19/30 • Number of events 76
|
|
Investigations
Weight gain
|
3.3%
1/30 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
2/30 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
3.3%
1/30 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
6.7%
2/30 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
3.3%
1/30 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
43.3%
13/30 • Number of events 29
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.7%
2/30 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
10.0%
3/30 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.3%
1/30 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
63.3%
19/30 • Number of events 63
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Headache
|
6.7%
2/30 • Number of events 3
|
|
Nervous system disorders
Peripheral motor neuropathy
|
16.7%
5/30 • Number of events 14
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
40.0%
12/30 • Number of events 99
|
|
Nervous system disorders
Syncope
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Taste alteration
|
3.3%
1/30 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
3.3%
1/30 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
6/30 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.3%
7/30 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
13.3%
4/30 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
13.3%
4/30 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
5/30 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
3.3%
1/30 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
1/30 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
3.3%
1/30 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.3%
1/30 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
13.3%
4/30 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
50.0%
15/30 • Number of events 68
|
|
Vascular disorders
Hot flashes
|
3.3%
1/30 • Number of events 2
|
|
Vascular disorders
Lymphedema
|
3.3%
1/30 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place