Trial Outcomes & Findings for Phase II Open-Label Trial of Tarceva in Women With Metastatic, Hormone- and HER2-Negative Breast Cancer (NCT NCT00597597)

NCT ID: NCT00597597

Last Updated: 2023-05-17

Results Overview

From the Day of Initial Treatment (Day 0) Until Documented Disease Progression or Death.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: From the Day of Initial Treatment (Day 0) Until Documented Disease Progression or Death, whichever came first, assessed up to 6 months.
• Results posted on: 2023-05-17

Participant Flow

Participant milestones

Measure	Erlotinib: 150mg/Day Erlotinib: 150mg/day.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Open-Label Trial of Tarceva in Women With Metastatic, Hormone- and HER2-Negative Breast Cancer

Baseline characteristics by cohort

Measure	A Phase II Open-Label Clinical Trial to Evaluate the Efficacy n=11 Participants Open label; all subjects receive active drug, Erlotinib Erlotinib: During the treatment period, subjects will receive single agent erlotinib, 150mg/day. All patients receive the study drug, erlotinib, at the dose of 150 mg/day Patients were eligible if they had locally recurrent or metastatic breast cancer that was triple negative and positive for EGFR. EGFR positivity was defined as staining in \>10% of tumor cells by immunohistochemistry (Dako). Patients required measurable disease on imaging or physical examination, prior treatment with anthracycline and taxane (either in adjuvant or metastatic setting) and ≤1 prior chemotherapy in the metastatic setting. Patients received erlotinib 150mg daily.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	56.7 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the Day of Initial Treatment (Day 0) Until Documented Disease Progression or Death, whichever came first, assessed up to 6 months.

From the Day of Initial Treatment (Day 0) Until Documented Disease Progression or Death.

Outcome measures

Measure	A Phase II Open-Label Clinical Trial to Evaluate the Efficacy n=11 Participants Open label; all subjects receive active drug, Erlotinib Erlotinib: During the treatment period, subjects will receive single agent erlotinib, 150mg/day.
The Primary Objective of the Study is Progression Free Survival.	0.08 years Standard Deviation 1.2

SECONDARY outcome

Timeframe: every 8 weeks, up to 6 months

Overall response rate, consisting of complete and partial responses according to RECIST criteria "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."

Outcome measures

Measure	A Phase II Open-Label Clinical Trial to Evaluate the Efficacy n=11 Participants Open label; all subjects receive active drug, Erlotinib Erlotinib: During the treatment period, subjects will receive single agent erlotinib, 150mg/day.
Overall Response Rate, Consisting of Complete and Partial Responses According to RECIST Criteria	0 Participants

SECONDARY outcome

Timeframe: very 8 weeks, up to 6 months

We measured the clinical benefit, consisting of complete and partial responses, and stable disease for six months

Outcome measures

Measure	A Phase II Open-Label Clinical Trial to Evaluate the Efficacy n=10 Participants Open label; all subjects receive active drug, Erlotinib Erlotinib: During the treatment period, subjects will receive single agent erlotinib, 150mg/day.
Clinical Benefit, Consisting of Complete and Partial Responses, and Stable Disease for Six Months	2 participants

SECONDARY outcome

Timeframe: every 8 weeks, up to 6 months

Population: 0 patients were observed to have an objective response

Objective response is defined as complete or partial response

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Number of Participants With Adverse Events

Outcome measures

Measure	A Phase II Open-Label Clinical Trial to Evaluate the Efficacy n=11 Participants Open label; all subjects receive active drug, Erlotinib Erlotinib: During the treatment period, subjects will receive single agent erlotinib, 150mg/day.
Safety of Erlotinib	2 participants

SECONDARY outcome

Timeframe: every 8 weeks, up to 6 months

We evaluated the number of Participants with Rash

Outcome measures

Measure	A Phase II Open-Label Clinical Trial to Evaluate the Efficacy n=11 Participants Open label; all subjects receive active drug, Erlotinib Erlotinib: During the treatment period, subjects will receive single agent erlotinib, 150mg/day.
Number of Participants With Rash	1 Participants

Adverse Events

A Phase II Open-Label Clinical Trial to Evaluate the Efficacy

Serious events: 2 serious events

Other events: 0 other events

Deaths: 11 deaths

Serious adverse events

Measure	A Phase II Open-Label Clinical Trial to Evaluate the Efficacy n=11 participants at risk Open label; all subjects receive active drug, Erlotinib Erlotinib: During the treatment period, subjects will receive single agent erlotinib, 150mg/day.
Skin and subcutaneous tissue disorders Rash	9.1% 1/11 • Number of events 1 • 2 years
Gastrointestinal disorders diarrhea	18.2% 2/11 • Number of events 2 • 2 years
Gastrointestinal disorders nausea	9.1% 1/11 • Number of events 1 • 2 years
General disorders weight loss	9.1% 1/11 • Number of events 1 • 2 years

Other adverse events

Adverse event data not reported

Additional Information

Ruta Rao

Rush University Medical Center

Phone: 312-942-3324

Email: ruta_d_rao@rush.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place