At a glance
ClinicalIndex Comparison RecordEarly Ph 1Completed· 7 enrolled
Drug / intervention
Fulvestrant +2 moredrug
Likely dose
Fulvestrant 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib: A Randomized Pilot Trial With ESR1 Mutation Tested in Circulating Tumor DNA.
In Brief
A Early Phase 1 clinical trial evaluating Fulvestrant, Tamoxifen, and 1 other intervention for Metastatic Breast Cancer. Completed, enrolled 7 participants across 1 site.
Detailed Summary
To assess longitudinal changes in allele frequency of ESR1 mutation in plasma in patients treated with Fulvestrant plus palbociclib compared to tamoxifen plus palbociclib
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUnited States
Collaborators--
Timeline
Early Ph 1CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartApr 2018
Primary CompletionApr 2022
Study CompletionApr 2024
TodayJul 2026
First PostedSep 23, 2016
Enrollment StartApr 24, 2018
Primary CompletionApr 12, 2022
Study CompletionApr 30, 2024
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 9.8 years ago
Interventions
Fulvestrantdrug
500mg IM Q28 days
Tamoxifendrug
20mg PO Qdaily
Palbociclibdrug
Tamoxifen or Fulvestrant plus palbociclib125mg/day PO on a 21 days on/7 days off schedule