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

Pfizer

Status: Completed

Conditions: Metastatic HER2+ Advanced Breast Cancer

Treatments: Drug: Tucatinib; Drug: Capecitabine; Drug: Trastuzumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06961331

C4251025

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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:

1. 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)
2. Patients treated with tucatinib prior to T-DXd
3. Patients participating in clinical trials
4. Patients receiving concomitant endocrine therapy on index line

Trial design

86 participants in 1 patient group

3L+4L tucatinib triplet patients

Description:

Non-interventional, retrospective cohort analysis of participants receiving the tucatinib triplet in the 3L or 4L setting immediately following T-DXd.

Treatment:

Drug: Trastuzumab

Drug: Capecitabine

Drug: Tucatinib