Trial Outcomes & Findings for Phase 2 Study of Trastuzumab and Etoposide for Her2 Positive Breast Cancer (NCT NCT00810017)

NCT ID: NCT00810017

Last Updated: 2022-05-19

Results Overview

To determine the overall response rate

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: The best overall response is the best response recorded from the start of first treatment until the date of first progression or date of death from any cause whichever came first, assessed up to 24 months
• Results posted on: 2022-05-19

Participant Flow

Participant milestones

Measure	Single Arm Study Etoposide 100mg/m2 daily x 3 days Q3W and Trastuzumab 8mg/kg loading dose then 6mg/kg, then single agent until disease progression Etoposide: etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles Trastuzumab: intravenous trastuzumab 8 mg/kg loading dose and then 6 mg/kg every three weeks and then single agent trastuzumab until progression of disease
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 2 Study of Trastuzumab and Etoposide for Her2 Positive Breast Cancer

Baseline characteristics by cohort

Measure	Single Arm Study n=2 Participants Etoposide 100mg/m2 daily x 3 days Q3W and Trastuzumab 8mg/kg loading dose then 6mg/kg, then single agent until disease progression Etoposide: etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles Trastuzumab: intravenous trastuzumab 8 mg/kg loading dose and then 6 mg/kg every three weeks and then single agent trastuzumab until progression of disease
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: The best overall response is the best response recorded from the start of first treatment until the date of first progression or date of death from any cause whichever came first, assessed up to 24 months

Population: Study was terminated and no results were collected.

To determine the overall response rate

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From the start of first treatment until unacceptable toxicity or date of death, whichever came first, over 24 months

Population: Study was terminated and no results were collected.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Stable disease is measured from the start of the treatment until the criteria for progression are met, assessed by CT scans at a minimum interval of 8 weeks over 5 years

Population: Study was terminated and no results were collected.

Stable disease

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time to disease progression is defined as time from registration date to the date of documented disease progression or death on study, whichever occurs first for 5 years

Population: Study was terminated and no results were collected.

Time to disease progression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: The progression-free survival rate is defined as the percentage of patients who are without disease progression while on the study treatment at the end of study, over 5 years

Population: Study was terminated and no results were collected.

The duration of overall response will be measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started. The duration of overall CR is measured from the time measurements are met for CR until the first date that recurrent disease is objectively documented

Outcome measures

Outcome data not reported

Adverse Events

Single Arm Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Scientific Center Administrator, Oncology Research

MedStar Health Research Institute

Phone: (301) 560-7300

Email: Research@MedStar.net

Results disclosure agreements

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