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Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib

NCT02913430 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-09-23

Study results available
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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

Conditions

Interventions

DRUG

Fulvestrant

500mg IM Q28 days

DRUG

Tamoxifen

20mg PO Qdaily

DRUG

Palbociclib

Tamoxifen or Fulvestrant plus palbociclib125mg/day PO on a 21 days on/7 days off schedule

Sponsors & Collaborators

  • Shannon Puhalla

    lead OTHER

Principal Investigators

  • Shannon Puhalla, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-24
Primary Completion
2022-04-12
Completion
2024-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02913430 on ClinicalTrials.gov