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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
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free Survival (PFS)
Secondary study objectives
6-Month Clinical Benefit Rate (CBR)
Best Overall Response (BOR)
Clinical Benefit Rate (CBR)
+1 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1 spots leftby Nov 2025
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