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Association details:
| Biomarker: | HR positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | patritumab deruxtecan (U3-1402) (Topoisomerase I inhibitor, HER3-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer
Excerpt:
...- Adults with histologically-confirmed HER2 negative, unresectable locally advanced or metastatic breast cancer that is hormone receptor positive (HR+) at the time of the first breast cancer diagnosis...
Trial ID:
Source:
Title:
Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer
Excerpt:
...Has documented hormone (estrogen and/or progesterone) receptor (HR)-positive and HER2 negative expression according to American Society of Clinical Oncology...
Trial ID:
Less C2 evidence
Source:
Title:
Patritumab Deruxtecan (HER3-DXd), a Human Epidermal Growth Factor Receptor 3–Directed Antibody-Drug Conjugate, in Patients With Previously Treated Human Epidermal Growth Factor Receptor 3–Expressing Metastatic Breast Cancer: A Multicenter, Phase I/II Trial
Published date:
10/06/2023
Excerpt:
Patritumab deruxtecan (HER3-DXd) is an investigational HER3-targeted antibody-drug conjugate that is being evaluated as a novel treatment in HER3-expressing advanced breast cancer in the U31402-A-J101 study...Efficacy results are reported across clinical subtypes: hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2-negative) breast cancer (n = 113; objective response rate [ORR], 30.1%; median progression-free survival [mPFS], 7.4 months), triple-negative breast cancer (n = 53; ORR, 22.6%; mPFS, 5.5 months), and HER2-positive breast cancer (n = 14; ORR, 42.9%; mPFS, 11.0 months).
DOI:
10.1200/JCO.23.00882
Trial ID:
Source:
Title:
Patritumab Deruxtecan in Untreated Hormone Receptor-Positive/HER2-Negative Early Breast Cancer: Final Results from Part A of the Window-of-Opportunity SOLTI TOT-HER3 Pre-Operative Study
Published date:
05/19/2023
Excerpt:
Among patients evaluable for clinical response (n=62), an overall response rate of 45% was observed (tumor measurement by caliper), with a trend toward an increase in CelTIL score among responders compared with non-responders (mean difference, +11.9 vs +1.9)....A single dose of HER3-DXd was associated with clinical response, increased immune infiltration, suppression of proliferation in HR-positive/HER2-negative early breast cancer, and a tolerable safety profile consistent with previously reported results.
DOI:
10.1016/j.annonc.2023.05.004
Source:
Title:
189O - A phase 2 Study of Patritumab Deruxtecan (HER3-DXd), in patients (pts) with advanced breast cancer (ABC), with biomarker analysis to characterize response to therapy (ICARUS-BREAST01)
Published date:
05/07/2023
Excerpt:
ICARUS-BREAST01 (NCT04965766) is an ongoing multi-center, single-arm, phase II study in pts with HR+ and HER2- ABC, unselected for HER3 expression, who progressed on CDK 4/6 inh, any line of targeted/ET and 1 line of chemotherapy for ABC...Enrolled pts receive HER3-DXd 5.6 mg/kg IV every 3 weeks....Pts and treatment characteristics are reported in the table. Among the 56 pts: 16 had partial response, 30 stable disease, 10 progressive disease....HER3-DXd showed early signs of activity and a manageable safety profile in pts with HR+ HER2- ABC.
Trial ID:
Source:
Title:
LBA3 - Patritumab deruxtecan (HER3-DXd) in early-stage HR+/HER2- breast cancer: final results of the SOLTI TOT-HER3 window of opportunity trial
Published date:
05/03/2022
Excerpt:
In untreated early HR+/HER2- BC, a single dose of HER3-DXd led to clinically meaningful response, increased immune infiltration and suppression of proliferation across varied levels of baseline ERBB3 mRNA.
Trial ID:
Source:
Title:
Activity of patritumab deruxtecan, a HER3-directed antibody drug conjugate, in early breast cancer according to ERBB3 expression: Interim analysis results of a window-of-opportunity study (SOLTI-1805 TOT-HER3)
Published date:
10/09/2021
Excerpt:
This is a prospective, phase 0, multicenter, single arm trial planned to enroll 80 patients with treatment naïve hormone receptor positive, HER2 negative primary operable BC...At C1D21, a total of 12 (44%) patients experienced a response (7 complete and 5 partial response) by clinical palpation....In this interim trial analysis, a single dose of patritumab deruxtecan was associated with clinical response and important biological changes irrespective of baseline ERBB3 expression.
Trial ID:
