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OpenTrials
Completed

NCT Number: NCT06961331

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

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.

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Key information

Conditions

Metastatic HER2+ Advanced Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

New York, 10001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Tucatinib

Drug

As provided in real world practice.

Trastuzumab

Drug

As provided in real world practice.

Capecitabine

Drug

As provided in real world practice.

Primary outcomes

  1. Time to Next Treatment

    Time frame: 1 Year

    Time to next treatment defined as the time in months from the initiation of therapy to the initiation of subsequent LOT or death.

  2. Time to Discontinuation

    Time frame: 1 Year

    Time to treatment discontinuation defined as the time in months from initiation of therapy to discontinuation for any reason or death.

  3. Overall survival (OS)

    Time frame: 1 Year

    OS will be defined as the time in months from initiation of therapy to death from any cause.

  4. real-world Progression free survival (rwPFS)

    Time frame: 1 Year

    rwPFS will be defined as time in months from initiation of therapy to progression or death from any cause.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Real-world Clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan for the Treatment of HER2-postive Metastatic Breast Cancer

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 7, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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