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Hormone Therapy

Arm A for Breast Cancer

Phase < 1
Waitlist Available
Led By Shannon Puhalla, MD
Research Sponsored by Shannon Puhalla
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This study is evaluating whether there are differences in the frequency of ESR1 mutations in plasma between patients treated with Fulvestrant plus palbociclib and patients treated with Tamoxifen plus palbociclib.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in allele frequency of ESR1 mutation
Number of participants with treatment-related adverse events
RNAseq for functionality of ESR1
Secondary outcome measures
Assessment ESR1 status
Changes in circulating levels of ESR1-mt
Clinical benefit rate (CBR)
+3 more

Trial Design

2Treatment groups
Active Control
Group I: Arm AActive Control2 Interventions
fulvestrant administered 500mg IM Q28 days plus palbociclib125mg/day PO on a 21 days on/7 days off schedule
Group II: Arm BActive Control2 Interventions
Tamoxifen is administered orally, at a dose of20mg PO Qdaily plus palbociclib125mg/day PO on a 21 days on/7 days off schedule

Find a Location

Who is running the clinical trial?

Shannon PuhallaLead Sponsor
Shannon Puhalla, MDPrincipal InvestigatorUniversity of Pittsburgh

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib
Shannon Puhalla 2018. "Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02913430.
All > Metastatic Breast Cancer
~1 spots leftby Apr 2025
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