Trial Outcomes & Findings for Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast Cancer (NCT NCT00503841)
NCT ID: NCT00503841
Last Updated: 2019-04-30
Results Overview
TERMINATED
NA
44 participants
Baseline and day 0
2019-04-30
Participant Flow
44 participants signed consent starting 1-9-08 and recruitment ending with the last participant signing on 1-19-10. All participants enrolled onto screening portion of study, but none were ever put onto the "treatment" portion of the study.
All participants that signed consent were screen failures.
Participant milestones
| Measure |
Erlotinib Hydrochloride
If participants would have went onto study they would receive erlotinib(Tarceva®)hydrochloride 150 mg/day starting dose PO (orally) self-administered, QD (every day) on days -14 until day 0 immediately prior to scheduled surgery, Tissue sent for biomarker modulation analysis
Treatment continues in the absence of disease progression or unacceptable toxicity.
Biomarker analysis performed, toxicity monitored for 7 days following last dose of erlotinib (Tarceva®)
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
| Measure |
Erlotinib Hydrochloride
If participants would have went onto study they would receive erlotinib(Tarceva®)hydrochloride 150 mg/day starting dose PO (orally) self-administered, QD (every day) on days -14 until day 0 immediately prior to scheduled surgery, Tissue sent for biomarker modulation analysis
Treatment continues in the absence of disease progression or unacceptable toxicity.
Biomarker analysis performed, toxicity monitored for 7 days following last dose of erlotinib (Tarceva®)
|
|---|---|
|
Overall Study
All screen failures
|
44
|
Baseline Characteristics
Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast Cancer
Baseline characteristics by cohort
| Measure |
Erlotinib Hydrochloride
n=44 Participants
If participants would have went onto study they would receive erlotinib hydrochloride PO (orally) QD (every day) on days -14-0 immediately prior to scheduled surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and day 0Population: No participants received the study drug erlotinib hydrochloride.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and day 0Population: No data collected for secondary hypotheses.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and day 0Population: No data collected for secondary hypotheses.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At day -7, prior to surgery, and 1 week post-surgeryPopulation: No data collected for secondary hypotheses.
Outcome measures
Outcome data not reported
Adverse Events
Erlotinib Hydrochloride
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Elaina Gartner
Barbara Ann Karmanos Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place