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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | Enhertu (fam-trastuzumab deruxtecan-nxki) (Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Title:
NHS Scotland Grants Trastuzmab Deruxtecan Approval for Use in Pretreated HER2+ Metastatic Breast Cancer
Excerpt:
The Scottish Medicines Consortium (SMC) has accepted fam-trastuzumab deruxtecan-nxki (Enhertu) as a treatment option for adult patients with HER2-positive unresectable or metastatic breast cancer who have received 1 prior anti–HER2-based therapy....The advice is based on findings from the pivotal phase 3 DESTINY-Breast03 trial (NCT03529110), in which trastuzumab deruxtecan led to a 12-month progression-free survival (PFS) rate of 75.8%...
Source:
Title:
Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)
Excerpt:
...is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+) 3....
Source:
Title:
A study of Trastuzumab Deruxtecan to assess its safety, tolerability, immune response, and inhibition of tumor activity when given alone or in combination with other agents in patients with HER2- expressing Gastric Cancer
Excerpt:
...Disease Characteristics: a/Locally advanced, unresectable, or metastatic disease based on most recent imagingb/For Part 1, 2, 3a, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local tissue testing resultsc/For Part 3b, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on local tissue testing results3. ...
Trial ID:
More C2 evidence
Source:
Title:
DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
Excerpt:
...- Pathologically documented, locally advanced/metastatic breast cancer that has centrally determined HER2-positive expression as per American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) Guidelines...
Trial ID:
Source:
Title:
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
Excerpt:
...HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment....
Trial ID:
Source:
Title:
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
Excerpt:
...For Part 1, 2, 3a, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local tissue testing results 3....
Trial ID:
Source:
Title:
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
Excerpt:
...- Histologically documented HER2-positive early breast cancer (EBC) participants, including clinical stage at presentation (based on mammogram or breast MRI assessment): T0-4 (inclusive of inflammatory breast cancer), N1-3, M0 or ≥ T3, N0, M0 as determined by the AJCC staging system, 8th edition...
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:
...As prespecified in the protocol, participants enrolled in Part 1 were pooled according to their trastuzumab deruxtecan dose and HER2 expressing levels (HER2 positive or HER2 low) for efficacy analyses. ...
Trial ID:
Source:
Title:
A Multi-center Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer
Excerpt:
...To present real-world clinical outcomes of trastuzumab-deruxtecan as third-line or later treatment in HER2-positive gastric 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:
Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)
Excerpt:
...Prior neoadjuvant or adjuvant therapy that does * Locally or centrally confirmed HER2-positive (IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH) as classified by ASCO-CAP on a tumor biopsy obtained after progression on or after a first-line trastuzumab or approved trastuzumab biosimilar-containing regimen. ...
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:
...- Pathologically documented HER2-positive breast cancer (BC):...
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:
Basket Study for Oligo-metastatic Breast Cancer
Excerpt:
...- Histologic proof of infiltrating HER2-positive breast cancer (as determined by IHC 3+ and/or amplification by ISH)[8]...
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:
A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
Excerpt:
...Real World Time to Next Treatment (rwTTNT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer...
Trial ID:
Source:
Title:
An Observational Study of Patients Receiving T-DXd for Treatment of HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer
Excerpt:
...- Documented HER2-positive status via a validated method on the most recent sample tested in or closest to the metastatic setting as available....
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:
......
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:
...Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)...
Trial ID:
Source:
Title:
DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
Excerpt:
...- Has pathologically documented HER2-positive gastric or GEJ cancer that is unresectable or metastatic, and that progressed during or after treatment regimen containing trastuzumab...
Trial ID:
Source:
Title:
EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan
Excerpt:
...- Participants for whom T-DXd treatment is indicated, according to the summary of product characteristics conditionally approved by the EMA, that are eligible for treatment with T-DXd through the NPP (i.e., those with advanced/metastatic HER2+ breast cancer who have received ≥ 2 prior anti-HER2-based regimens and have documentation of HER2 positive tumour status by a validated method) will be eligible for inclusion to this RWD collection, subject to providing written informed consent to participate....
Trial ID:
Source:
Title:
A Study of Trastuzumab DeRuxtecan for Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction AdEnocarcinoma Who Have Received a PrIor Trastuzumab-based Regimen Accompanied by a Disease RegistrY of Patients Treated With Conventional Therapies (PROSPERITY)
Excerpt:
...- Histological or cytological confirmed diagnosis of advanced HER2 positive gastric cancer or GEJ...
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:
Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
Excerpt:
...HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer....
Trial ID:
Source:
Title:
Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer (SHAMROCK Study)
Excerpt:
...Histologically confirmed HER2-positive breast cancer: o Documented HER2 overexpression by local laboratory (IHC 3+ or FISH or CISH positive on diagnostic breast biopsy)....
Trial ID:
Source:
Title:
A Phase II Study of T-DXd Plus SRT in HER2-positive Breast Cancer Brain Metastases
Excerpt:
...- Pathologically confirmed HER2 positive advanced breast cancer...
Trial ID:
Source:
Title:
DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease
Excerpt:
...HER2 positive status...
Trial ID:
Source:
Title:
A phase 2 clinical trial conducted investigate the effectiveness of trastuzumab deruxtecan (T-DXd) administered before surgery for the treatment of HER-2 positive breast cancer.
Excerpt:
...Histologically confirmed HER2-positive breast cancer:o Documented HER2 overexpression by local laboratory (IHC 3+ or FISH or CISH positive on diagnostic breast biopsy).3. ...
Trial ID:
Source:
Title:
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein
Excerpt:
...Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)`Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) of MAAA-1181a Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)`Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve During Dosing Interval (AUCtau) Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)`Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve During Dosing Interval (AUCtau) of MAAA-1181a Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)`Best Overall Response By The Investigator's Assessment (Unconfirmed) in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer`Objective Response Rate (Unconfirmed) As Assessed in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer`Disease Control Rate (Unconfirmed) As Assessed in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer...
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:
Source:
Title:
Real-world efficacy and safety of T-DXd monotherapy or in combination with radiotherapy and endocrine therapy in breast cancer patients with HER2-positive or HER2-low brain metastases.
Excerpt:
......
Trial ID:
Source:
Title:
DESTINY-Breast11 will compare trastuzumab deruxtecan (T-DXd) alone or in sequence with other medications, known as THP, with standard of care treatment (ddAC-THP) and determine its safety and efficacy in patients with HER2-positive early breast cancer. Lo studio DESTINY-Breast11 confronterà trastuzumab deruxtecan (T-DXd) usato singolarmente o in sequenza con altri farmaci noti come THP, con la terapia standard ddAC-THP) e determinerà la sua sicurezza ed efficacia in pazienti con carcinoma mammario HER2-positivo in stadio precoce.
Excerpt:
...- Patients must be at least 18 years of age.- Histologically documented HER2-positive EBC participants with:(a) locally assessed HER2-positive (IHC 3+ or ISH+) according to ASCOCAP guidelines and prospectively centrally confirmed as HER2 positivebased on a tumour sample (b) unifocal and multifocal tumours (> 1 tumour confined to the same quadrant as the primary tumour) must have 1 focus sampled and centrally confirmed as HER2 positive(c) multi-centric tumours (multiple tumours involving > 1 quadrant of the breast) must have 1 lesion from each involved quadrant sampled and centrally confirmed as HER2 positive. ...
Trial ID:
Source:
Title:
DS-8201a in HER2-positive Gastric Cancer that cannot be surgically removed or has spread (DS-8201a) en sujetos con adenocarcinoma gástrico que no se puede extirpar quirúrgicamente o que se ha diseminado
Excerpt:
...Key Inclusion Criteria:- Men or women ≥18 years old (Please follow local regulatory requirements if the legal age of consent for study participation is >18 years old.)- Has pathologically documented gastric or GEJ cancer that is: - Unresectable or metastatic - Centrally confirmed HER2-positive disease (immunohistochemistry [IHC]3+, IHC2+/in-situ hybridization [ISH]+) as determined according to American Society of Clinical Oncology – College of American Pathologists (ASCO-CAP) guidelines based on a new tissue sample obtained after progression on or after a trastuzumabcontaining regimen. ...
Trial ID:
Source:
Title:
Clinical trial comparing Trastuzumab Deruxtecan with Trastuzumab Emtansine in high-risk HER2-positive patients with residual breast cancer following neoadjuvant therapy
Excerpt:
...HER2-positive breast cancer, meeting all of the criteria listed in the protocol (see protocol for full details). ...
Trial ID:
Less C2 evidence
Source:
Title:
Efficacy and safety of trastuzumab deruxtecan in patients with solid tumors: a systematic review and meta-analysis of 3 randomized controlled trials
Published date:
08/15/2023
Excerpt:
The results of the meta-analysis showed that the treatment group had significantly higher overall survival (WMD=5.12, 95% CI (2.79, 7.44), P<0.0001), progression-free survival (WMD=3.45, 95% CI (0.8, 6.1), P=0.01), overall response rate (OR=6.49, 95% CI (4.90, 8.58), P<0.00001), and disease control rate (OR=4.68, 95% CI (2.78, 7.89), P<0.00001), TRAEs (RR=6.93, 95% CI (2.06, 23.25), P=0.002)....Based on the available evidence, trastuzumab deruxtecan appears to be an effective and safe treatment option for HER2-positive solid tumors.