Trial Outcomes & Findings for Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer (NCT NCT00148668)
NCT ID: NCT00148668
Last Updated: 2013-04-09
Results Overview
Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
12 weeks
Results posted on
2013-04-09
Participant Flow
A total of 81 patients were enrolled on the study between 12/2003 and 8/2008.
Participant milestones
| Measure |
Herceptin/Navelbine
Herceptin( 2mg/kg)navelbine (25mg/kg2) x 12 weeks
|
Taxotere/Carboplatin/Herceptin
Taxotere (75mg/kg2)/carboplatin (AUC6)/herceptin(2mg/kg)\[TC q 3 weeks/H q 1 wk) x 4 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
|
Overall Study
COMPLETED
|
41
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1
n=41 Participants
Herceptin/navelbine
|
Arm 2
n=40 Participants
Taxotere/carboplatin/herceptin
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
47.8 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
48 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
40 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Please Note that in Arm 2, the number of participants analyzed is equal to 39, which differs from the Number of Participants reported in the baseline measure (N= 40) because one participant withdrew her consent, so was not evaluable.
Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery
Outcome measures
| Measure |
Arm 1
n=41 Participants
Herceptin/navelbine
|
Arm 2
n=39 Participants
Taxotere/carboplatin/herceptin
|
|---|---|---|
|
Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer
|
17 percentage of participants
|
31 percentage of participants
|
Adverse Events
Arm 1
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Arm 2
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=41 participants at risk
Herceptin/navelbine
|
Arm 2
n=40 participants at risk
Taxotere/carboplatin/herceptin
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
9.8%
4/41 • Number of events 4
|
10.0%
4/40 • Number of events 4
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
|
Hepatobiliary disorders
SGPT (ALT)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
Other adverse events
| Measure |
Arm 1
n=41 participants at risk
Herceptin/navelbine
|
Arm 2
n=40 participants at risk
Taxotere/carboplatin/herceptin
|
|---|---|---|
|
Immune system disorders
Leukocytes
|
14.6%
6/41 • Number of events 6
|
17.5%
7/40 • Number of events 7
|
|
Immune system disorders
Neutropenia
|
26.8%
11/41 • Number of events 11
|
12.5%
5/40 • Number of events 5
|
|
Immune system disorders
Febrile Neutropenia
|
2.4%
1/41 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
General disorders
Fatigue
|
2.4%
1/41 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/41 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
Hepatobiliary disorders
SGOT (AST)
|
7.3%
3/41 • Number of events 3
|
0.00%
0/40
|
|
Hepatobiliary disorders
SGPT (ALT)
|
9.8%
4/41 • Number of events 4
|
0.00%
0/40
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/41
|
5.0%
2/40 • Number of events 2
|
|
Blood and lymphatic system disorders
Dehydration
|
0.00%
0/41
|
5.0%
2/40 • Number of events 2
|
|
Reproductive system and breast disorders
Irregular Menses
|
0.00%
0/41
|
7.5%
3/40 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place