Real World-clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan (T-DXd) for the Treatment of HER2-positive Metastatic Breast Cancer.

Completed

Conditions studied: Metastatic HER2+ Advanced Breast Cancer

In brief

A retrospective study of de-identified (to preserve patient privacy) patient information from the Flatiron Health Database to describe 3L and 4L real-world (rw) outcomes (e.g. time to next treatment, time to discontinuation, and overal survival) of the tucatinib-trastuzumab-capecitabine triplet therapy immediately following T-DXd therapy in patients diagnosed with HER2+ metastatic breast cancer (mBC) in the United States.

Key facts

Study ID

NCT06961331

Run by

Pfizer

People needed

86

Starts

2025-05-07

Expected to finish

2025-09-25

Last updated by the study team

2026-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
• mBC diagnosis between January 1, 2017 and 6 months prior to database cutoff
• Evidence of human epidermal growth factor receptor 2 (HER2) receptor positivity prior to or up to 90 days following the mBC diagnosis date
• At least 18 years old on the mBC diagnosis date
• Treated with systemic anticancer treatment in the metastatic setting, i.e., post mBC diagnosis.
• Treated with T-DXd in the 1L or 2L or 3L setting, followed immediately by the tucatinib triplet, and at least 1 additional prior HER2-targeted regimen

You may not qualify if…

• Patients meeting any of the following criteria will not be included in the study:
• Patients with evidence of other cancers six months prior to the mBC diagnosis date will be identified with the following International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) and International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes in all databases: 140.xx - 195.xx, 200.xx - 208.xx, C00.xx - C76.xx, C81.xx - C96.xx. (exclude - ICD-9: 174.X, 175.X; ICD-10: C50.XX)
• Patients treated with tucatinib prior to T-DXd
• Patients participating in clinical trials
• Patients receiving concomitant endocrine therapy on index line

Where it is running

• Pfizer — New York, New York, United States

Full record on ClinicalTrials.gov

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