Trial Outcomes & Findings for Neoadjuvant GW572016 to Treat Breast Cancer (NCT NCT00206427)
NCT ID: NCT00206427
Last Updated: 2021-09-29
Results Overview
Clinical efficacy was assessed by bidimensional tumor measurements of the primary cancer at baseline, and at the end of week 6. Clinical complete response (cCR) was defined as complete disappearance of the primary tumor. Clinical partial response (cPR) was defined as a decrease by at least 50% of the sum of the products of the largest perpendicular diameters. An increase of more than 25% was defined as clinical progressive disease (cPD). Any response that does not meet the definition of cCR, cPR, or cPD was defined as stable disease (cSD).
COMPLETED
PHASE2
49 participants
at the end of week 6.
2021-09-29
Participant Flow
Participant milestones
| Measure |
GW572016 1500mg
The study had only 1 treatment group and all patient had GW572016 1500mg daily.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
GW572016 1500mg
The study had only 1 treatment group and all patient had GW572016 1500mg daily.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Neoadjuvant GW572016 to Treat Breast Cancer
Baseline characteristics by cohort
| Measure |
GW572016 1500mg
n=49 Participants
patients received GW572016 1500mg daily
|
|---|---|
|
Age, Continuous
|
53 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: at the end of week 6.Population: All patients finished 6-week therapy were included. Two patients dropped off therapy early were excluded.
Clinical efficacy was assessed by bidimensional tumor measurements of the primary cancer at baseline, and at the end of week 6. Clinical complete response (cCR) was defined as complete disappearance of the primary tumor. Clinical partial response (cPR) was defined as a decrease by at least 50% of the sum of the products of the largest perpendicular diameters. An increase of more than 25% was defined as clinical progressive disease (cPD). Any response that does not meet the definition of cCR, cPR, or cPD was defined as stable disease (cSD).
Outcome measures
| Measure |
GW572016 1500mg
n=47 Participants
patients received GW572016 1500mg daily
|
|---|---|
|
Clinical Response
cCR
|
3 participants
|
|
Clinical Response
cPR
|
30 participants
|
|
Clinical Response
cSD
|
11 participants
|
|
Clinical Response
cPD
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Samples from 47 patients who finished 6-week therapy were included. The numbers of biomarker data depended on available data due to missed biopsies or no tumor found in some samples.
Immunohistochemical staining of cells from patients breast biopsies at baseline and post-treatment (week 6) were performed. Biologic markers including EGFR, HER2, and pHER2 were assessed with intensity scores of the staining (0-3, higher score means higher intensity).
Outcome measures
| Measure |
GW572016 1500mg
n=47 Participants
patients received GW572016 1500mg daily
|
|---|---|
|
Inhibition of HER1 and HER2 Signaling as Determined by EGFR, HER2, and pHER2
EGFR at baseline
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Inhibition of HER1 and HER2 Signaling as Determined by EGFR, HER2, and pHER2
EGFR at week 6
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Inhibition of HER1 and HER2 Signaling as Determined by EGFR, HER2, and pHER2
HER2 at baseline
|
3 score on a scale
Interval 2.75 to 3.0
|
|
Inhibition of HER1 and HER2 Signaling as Determined by EGFR, HER2, and pHER2
HER2 at week 6
|
3 score on a scale
Interval 2.5 to 3.0
|
|
Inhibition of HER1 and HER2 Signaling as Determined by EGFR, HER2, and pHER2
pHER2 at baseline
|
1.5 score on a scale
Interval 0.0 to 2.5
|
|
Inhibition of HER1 and HER2 Signaling as Determined by EGFR, HER2, and pHER2
pHER2 at week 6
|
1.5 score on a scale
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Samples from 47 patients who finished 6-week therapy were included. The numbers of biomarker data depended on available data due to missed biopsies or no tumor found in some samples.
Immunohistochemical staining of cells from patients breast biopsies at baseline and post-treatment (week 6) were performed. Biologic markers of Ki67 and CC3 were assessed with percentages of cells staining positive (0%-100%, higher score means higher positive cells).
Outcome measures
| Measure |
GW572016 1500mg
n=47 Participants
patients received GW572016 1500mg daily
|
|---|---|
|
Inhibition of HER1 and HER2 Signaling as Determined by ki67 and CC3
Ki67 at baseline
|
71 percentage of cells staining positive
Interval 54.0 to 78.0
|
|
Inhibition of HER1 and HER2 Signaling as Determined by ki67 and CC3
Ki67 at week 6
|
49 percentage of cells staining positive
Interval 29.0 to 65.0
|
|
Inhibition of HER1 and HER2 Signaling as Determined by ki67 and CC3
CC3 at baseline
|
1.80 percentage of cells staining positive
Interval 0.82 to 3.11
|
|
Inhibition of HER1 and HER2 Signaling as Determined by ki67 and CC3
CC3 at week 6
|
1.84 percentage of cells staining positive
Interval 0.5 to 5.31
|
Adverse Events
GW572016 1500mg
Serious adverse events
| Measure |
GW572016 1500mg
n=49 participants at risk
patients received GW572016 1500mg daily
|
|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
2.0%
1/49 • Number of events 1 • During the 6-week therapy
|
|
Blood and lymphatic system disorders
Neutrophils/ANC
|
2.0%
1/49 • Number of events 2 • During the 6-week therapy
|
|
Blood and lymphatic system disorders
Leukocytes
|
2.0%
1/49 • Number of events 3 • During the 6-week therapy
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
2.0%
1/49 • Number of events 5 • During the 6-week therapy
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/49 • Number of events 1 • During the 6-week therapy
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
1/49 • Number of events 1 • During the 6-week therapy
|
|
Infections and infestations
Infection-oral thrush
|
2.0%
1/49 • Number of events 2 • During the 6-week therapy
|
|
Gastrointestinal disorders
Mucositis-oral
|
2.0%
1/49 • Number of events 2 • During the 6-week therapy
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
2.0%
1/49 • Number of events 1 • During the 6-week therapy
|
Other adverse events
| Measure |
GW572016 1500mg
n=49 participants at risk
patients received GW572016 1500mg daily
|
|---|---|
|
Skin and subcutaneous tissue disorders
Bruising
|
6.1%
3/49 • Number of events 4 • During the 6-week therapy
|
|
Gastrointestinal disorders
Diarrhea
|
46.9%
23/49 • Number of events 26 • During the 6-week therapy
|
|
Hepatobiliary disorders
Elevated AST
|
8.2%
4/49 • Number of events 4 • During the 6-week therapy
|
|
Gastrointestinal disorders
Nausea
|
8.2%
4/49 • Number of events 4 • During the 6-week therapy
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.1%
3/49 • Number of events 3 • During the 6-week therapy
|
|
Skin and subcutaneous tissue disorders
Rash
|
36.7%
18/49 • Number of events 20 • During the 6-week therapy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place