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Completed Phase 1Phase 2 Interventional Results available

Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer

ClinicalTrials.gov ID: NCT03054363

Public ClinicalTrials.gov record NCT03054363. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 3:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase IB/II Open-label Single Arm Study to Evaluate Safety and Efficacy of Tucatinib in Combination With Palbociclib and Letrozole in Subjects With Hormone Receptor Positive and HER2-positive Metastatic Breast Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a multicenter run-in phase Ib / roll-over phase II study of triple targeted drug combination (HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib and aromatase inhibitor letrozole) as a first or second line of therapy in patients with metastatic hormone receptor positive and HER2-positive breast cancer.

Study identification

NCT ID
NCT03054363
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
42 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 100 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 27, 2017 (Actual)
Primary completion
Jan 17, 2023 (Actual)
Completion
Feb 7, 2023 (Actual)
Last update posted
Nov 13, 2023

2017 – 2023

United States locations

U.S. sites
6
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
University of Arizona Tucson Arizona 85724 —
University of Colorado Denver Aurora Colorado 80045 —
Northwestern University Chicago Illinois 60611 —
New Mexico Cancer Care Alliance Albuquerque New Mexico 87131 —
Stony Brook University Stony Brook New York 11794 —
University of Texas Health Science Center San Antonio San Antonio Texas 78229 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03054363, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 13, 2023 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03054363 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →