CompletedNot Applicable

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

United States86 participantsStarted 2025-05-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 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

What they're measuring

Time to Next Treatment

Timeframe: 1 Year

Time to Discontinuation

Timeframe: 1 Year

Overall survival (OS)

Timeframe: 1 Year

real-world Progression free survival (rwPFS)

Timeframe: 1 Year

Trial details

NCT IDNCT06961331

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-09-25

View on ClinicalTrials.gov More Metastatic HER2+ Advanced Breast Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 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