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Association details:
| Biomarker: | HR positive |
|---|---|
| Cancer: | Hormone Receptor Positive Breast Cancer |
| Drug: | Enhertu (fam-trastuzumab deruxtecan-nxki) (Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Clinical trial comparing Trastuzumab Deruxtecan with Trastuzumab Emtansine in high-risk HER2-positive patients with residual breast cancer following neoadjuvant therapy
Excerpt:
...Known hormone receptor (HR) status, per local laboratory assessment, as defined by ASCO-CAP guidelines (≥1%): HR-positive status defined by either positive estrogen receptor (ER) or positive progesterone receptor (PR) status. ...
Trial ID:
Source:
Title:
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
Excerpt:
...Is documented as hormone receptor-positive (estrogen or progesterone receptor) or negative in the metastatic setting...
Trial ID:
More C2 evidence
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:
...- Known hormone receptor (HR) status, per local laboratory assessment, as defined by ASCO-CAP guidelines (≥1%): HR positive status defined by either positive estrogen receptor (ER) and/or positive progesterone receptor (PR)....
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:
...Is HR-positive or HR-negative 4....
Trial ID:
Source:
Title:
Study of DS-8201a, an Antibody Drug Conjugate for Advanced Breast Cancer Patients, With Biomarkers Analysis
Excerpt:
...- Patient with HER2 negative (IHC0, 1+, and 2+/ISH-) and hormone receptor positive (estrogen receptor (ER)+ and/or progesterone receptor (PR)+) tumor must be resistant to endocrine therapy and CDK4/6 inhibitors, and must have been treated with capecitabine....
Trial ID:
Source:
Title:
Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer
Excerpt:
...- Tumor is HR positive (HR+) per ASCO CAP guidelines with known estrogen and progesterone receptor status, locally defined...
Trial ID:
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:
...• Patient with HER2 negative (IHC0, 1+, and 2+/ISH-) and hormone receptor positive (ER+ and/or PR+) tumor must be resistant to endocrine therapy and CDK4/6 inhibitors, and must have been treated with capecitabine. ...
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:
...All quadrants tested must be centrally confirmed as HER2 positive(d) tumours documented as HR-positive (either ER and/or PgR positive [ER or PgR >= 1%]) or HR-negative (ER and PgR negative) by local assessment per ASCO-CAP guidelines (Allison et al 2020)(e) 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 (Hortobagyi et al 2017)(f) pathologic confirmation of nodal involvement with malignancy as determined by fine-needle aspiration or core-needle biopsy, when applicable.- FFPE tissue block (2 cores) or 20 freshly-cut, serial tumor slides for HER2 assessment by central lab. ...
Trial ID:
Source:
Title:
DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
Excerpt:
...- Participants must have exhausted treatments that can confer any clinically meaningful benefit (eg, other therapies such as hormonal therapy for participants who are hormone receptor positive)...
Trial ID:
Less C2 evidence
Source:
Title:
Trastuzumab deruxtecan (T-DXd) in combination with anastrozole or fulvestrant in patients with HER2-low HR+ advanced/metastatic breast cancer: a Phase 1b, open-label, multicenter, dose-expansion study (DESTINY-Breast08)
Published date:
12/02/2023
Excerpt:
Confirmed ORR was 71.4% (15/21; 95% confidence interval [CI] 47.8, 88.7) in the T-DXd + ANA arm, and 40.0% (8/20; 95% CI 19.1,64.0) in the T-DXd + FUL arm…T-DXd in combination with anastrozole or fulvestrant was active in first- or second-line treatment of patients with HER2-low HR+ mBC.
Secondary therapy:
fulvestrant; anastrozole
Trial ID: