At a glance
ClinicalIndex Comparison Record- ✓Invasive breast carcinoma that is HER2-positive (IHC 3+ and/or positive ISH) or HER2-low (IHC 1+ or IHC 2+ with negative ISH)
- ✓Complete resection of tumor with negative margins (R0)
- ✓Participation in SURVIVE study with evidence of molecular relapse (positive ctDNA)
- ✓No evidence of metastatic relapse (M0) confirmed by CT scan and SPECT bone scan within 8 weeks before randomization
- ✕Stage IV (metastatic) breast cancer
- ✕History of secondary primary malignancy (with exceptions: ipsi-/contralateral DCIS, curatively treated in-situ disease, adequately treated non-melanoma skin cancer)
- ✕Prior treatment with T-DXd
- ✕Combination of T-DXd with other anti-cancer treatment except endocrine therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
SURVIVE HERoes - A Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in eBC Patients With Molecular Relapse
In Brief
A Phase 3 clinical trial evaluating Trastuzumab-Deruxtecan and Physicians Choice (PhC). for Breast Cancer. Currently recruiting, targeting 180 participants across 1 site.
Detailed Summary
Prospective, multi-center, randomized, open label comparative Phase III study in patients with intermediate to high-risk (as defined in the SURVIVE trial) HER2-positive or HER2-low early breast cancer, who participate in the SURVIVE trial and experience a molecular relapse, as assessed based on a positive circulating tumor DNA (ctDNA) result, with 2:1 allocation to: * Arm A: Trastuzumab-Deruxtecan (i.v. 5,4 mg/kg, q3w) + endocrine therapy (if hormonal-receptor-positive) for 16 cycles or until relapse, if earlier * Arm B: Continuous treatment of physician's choice (may include endocrine treatment, CDK4/6-Inhibition, T-DM1, Olaparib, Trastuzumab, Pertuzumab, Capecitabine or Neratinib)
Study Details
Timeline
Interventions
Trastuzumab-Deruxtecan (i.v. 5,4 mg/kg, q3w) + endocrine therapy (if hormonal-receptor-positive) for 16 cycles or until relapse, if earlier
Continuous treatment of physician's choice (may include endocrine treatment, CDK4/6-Inhibition, T-DM1, Olaparib, Trastuzumab, Pertuzumab, Capecitabine or Neratinib)