Clinical trial NCT06961331: Real World-clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan (T-DXd) for the Treatment of HER2-positive Metastatic Breast Cancer.
Official title: Real-world Clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan for the Treatment of HER2-postive Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metastatic HER2+ Advanced Breast Cancer
Keywords: her2+
mBC
metastatic breast cancer
tukysa
tucatinib
breast neoplasm
Human epidermal growth factor receptor 2 positive
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-05-07
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include participants in the US Flatiron PANORAMIC Dataset diagnosed with HER2+ mBC treated with the tucatinib triplet in the post-T-DXd setting.

Brief 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.


Eligibility criteria: Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. mBC diagnosis between January 1, 2017 and 6 months prior to database cutoff
2. Evidence of human epidermal growth factor receptor 2 (HER2) receptor positivity prior to or up to 90 days following the mBC diagnosis date
3. At least 18 years old on the mBC diagnosis date
4. Treated with systemic anticancer treatment in the metastatic setting, i.e., post mBC diagnosis.
5. Treated with T-DXd in the 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:

1. Patients with evidence of other cancers 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)
2. Patients treated with tucatinib or T-DXd prior to the 2L or 3L T-DXd treatment
3. Patients participating in clinical trials
4. Patients receiving concomitant endocrine therapy

Primary outcomes:
measure: Time to Next Treatment
timeFrame: 1 Year
measure: Time to Discontinuation
timeFrame: 1 Year
measure: Overall survival (OS)
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: