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Association details:
| Biomarker: | HER-2 expression |
|---|---|
| Cancer: | Breast Cancer |
| Drug: | Enhertu (fam-trastuzumab deruxtecan-nxki) (Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Title:
ENHERTU® (fam-trastuzumab deruxtecan-nxki) approved in the US as first tumor-agnostic HER2-directed therapy for previously treated patients with metastatic HER2-positive solid tumors
Excerpt:
...ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
Source:
Title:
Phase 2, Open label Study of DS-8201a, an Anti-HER2-AntIbody Drug Conjugate (ADC) for advanced BreaSt Cancer patients, with biomarkers analysis to characterize response/resistance to therapY
Excerpt:
...Additionally: • Patient with HER2 over-expressing (IHC3+ and IHC2+/ISH+) tumor must have been treated and have progressed on trastuzumab and on TDM-1. ...
Trial ID:
Source:
Title:
DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
Excerpt:
...- Pathologically documented HER2-expressing locally advanced/metastatic breast cancer, and HER2-expressing or HER2-mutant locally advanced/metastatic NSCLC...
Trial ID:
More C2 evidence
Source:
Title:
A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer
Excerpt:
...Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay 2....
Trial ID:
Source:
Title:
Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer
Excerpt:
...- Patients must have HER2-positive or HER2-expressing tumors as defined by Clinical Laboratory Improvement Act (CLIA)-certified labs....
Trial ID:
Source:
Title:
Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer
Excerpt:
...Number of Participants With Dose-Limiting Toxicities at 3.2 mg/kg and 5.4 mg/kg Dose Level in Participants With HER2-expressing Advanced Breast Cancer in Dose Escalation`Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review in Participants With HER2-expressing Advanced Breast Cancer or Urothelial Cancer...
Trial ID:
Source:
Title:
DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
Excerpt:
...has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology...
Trial ID:
Source:
Title:
A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)
Excerpt:
...- HER2-positive expression defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) confirmed prior to study randomization....
Trial ID:
Source:
Title:
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Excerpt:
...has HER2 positive expression confirmed per protocol...
Trial ID:
Source:
Title:
DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]
Excerpt:
...has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology...
Trial ID:
Source:
Title:
Trastuzumab Deruxtecan (T-DXd): Tailoring Treatment and Companion Diagnostics (CDx) by Liquid Biopsy
Excerpt:
...- Subjects must have confirmed, per local testing on most recent tumor tissue sample available, an HER2-positive expression, as determined according to American Society of Clinical Oncology...
Trial ID:
Source:
Title:
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
Excerpt:
...has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested) 3....
Trial ID:
Source:
Title:
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
Excerpt:
...Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) 3....
Trial ID:
Source:
Title:
DESTINY Breast Respond HER2-low Europe
Excerpt:
...Real World Time to Next Treatment (rwTTNT1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer...
Trial ID:
Source:
Title:
A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer
Excerpt:
...unresectable/advanced or metastatic; confirmed HER2-positive status expression as determined according to American Society of Clinical Oncology/College of American Pathologists guidelines -...
Trial ID:
Source:
Title:
DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease
Excerpt:
...HER2-low expressing status...
Trial ID:
Source:
Title:
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein
Excerpt:
...- Has a pathologically documented unresectable or metastatic gastric or GEJ adenocarcinoma, or breast cancer, with HER2 expression [immunohistochemistry (IHC) 3+, 2+, or 1+ and/or in situ hybridization (ISH) +] that is refractory to or intolerable with standard treatment, or for which...
Trial ID:
Source:
Title:
Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer
Excerpt:
...- Has a pathologically documented unresectable or metastatic breast cancer with HER2 expression (immunohistochemistry [IHC] 3+, IHC 2+, IHC 1+ and/or in situ hybridization [ISH] +) that is refractory to or intolerable with standard treatment, or for which...
Trial ID:
Source:
Title:
A real-world study of the efficacy and safety of DS-8201 in the treatment of advanced breast cancer and the exploration of biomarkers for predictive efficacy
Excerpt:
...HER2 low expression (1+/++) or overexpression;...
Trial ID:
Source:
Title:
A Prospective Clinical Study Evaluating the Predictive Value of MRI Radiomics with Machine Learning Algorithms for Treatment Response to Trastuzumab Deruxtecan in Breast Cancer Patients with Brain Metastases
Excerpt:
......
Trial ID:
Less C2 evidence
Source:
Title:
The efficacy and safety of trastuzumab deruxtecan (T-DXd) in HER2-expressing solid tumours: a single-arm meta-analysis
Published date:
04/27/2023
Excerpt:
Overall, the efficacy of T-DXd in treating HER2-expressing solid tumours is encouraging, especially breast and non-small cell lung cancers, and has an acceptable safety profile.
DOI:
10.1093/jjco/hyad036