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 range

18 Years

Sex

ALL

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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)