Trial Outcomes & Findings for Fulvestrant and/or Trastuzumab as First-Line Therapy in Treating Postmenopausal Women With Stage IV Breast Cancer (NCT NCT00138125)

Results Overview

Of the two treated patients on this trial, the records show that one patient who received Herceptin only completed 3 cycles of therapy, while the second patient who received Herceptin in combination with Faslodex completed 9 cycles of therapy. The last survival data collected from October to November 2008 showed that these two participants were alive at that time.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

5 years

Results posted on

2020-10-19

Participant Flow

recruitment period from June 2005 - August 2008 at academic medical clinics and community medical clinics.

Participant milestones

Participant milestones
Measure	Faslodex + Herceptin Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter. Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fulvestrant and/or Trastuzumab as First-Line Therapy in Treating Postmenopausal Women With Stage IV Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Faslodex + Herceptin n=2 Participants Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter. Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants
Sex: Female, Male Female	2 Participants n=39 Participants
Sex: Female, Male Male	0 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants

PRIMARY outcome

Timeframe: 5 years

Of the two treated patients on this trial, the records show that one patient who received Herceptin only completed 3 cycles of therapy, while the second patient who received Herceptin in combination with Faslodex completed 9 cycles of therapy. The last survival data collected from October to November 2008 showed that these two participants were alive at that time.