Trastuzumab Deruxtecan Plus ivonescImab for Hormone Receptor-positive HER2 Negative Advanced Breast Cancer Study
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The UNITY study is a prospective, single-arm, single-center, Phase II clinical trial conducted by Fudan University Shanghai Cancer Center. It aims to evaluate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) combined with ivonescimab in patients with hormone receptor-positive (HR+), HER2-negative recurrent or metastatic breast cancer. Approximately 53 patients will be enrolled. Eligible participants must have histologically confirmed advanced HR-positive breast cancer with HER2-low or HER2-ultralow expression. They must have experienced recurrence, metastasis, or disease progression after prior treatment with a CDK4/6 inhibitor (including in the adjuvant setting) and have received at most one line of systemic chemotherapy for advanced disease. The study permits the enrollment of patients with central nervous system (CNS) metastases. The primary endpoint is the Overall Response Rate (ORR). Key secondary endpoints include Clinical Benefit Rate (CBR), Overall Survival (OS), Progression-Free Survival (PFS), safety, and patient-reported quality of life (assessed using EORTC QLQ-C30 and QLQ-BR23). Exploratory endpoints will involve the analysis of biomarkers from tumor and blood samples, as well as PAM50 molecular subtyping and its correlation with survival outcomes. This study seeks to explore the efficacy and safety of Trastuzumab Deruxtecan in combination with ivonescimab for patients with HR-positive, HER2-negative recurrent or metastatic breast cancer, with a particular focus on the subpopulation with CNS metastases.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej.
- •Ogólny stan zdrowia pozwalający na aktywność (ECOG 0-2).
- •Potwierdzony rak piersi HR+ z niską ekspresją HER2 (HER2-low lub HER2-ultralow).
- •Rak nawrotowy lub z przerzutami, nieuleczalny operacyjnie lub radioterapią.
- •Przed leczeniem pacjentka otrzymała lek z grupy inhibitorów CDK4/6.
- •Pacjentka otrzymała maksymalnie jedną linię chemioterapii z powodu zaawansowanego raka.
- •Pacjentki z przerzutami do mózgu są kwalifikowane do badania.
- •Dostępna jest próbka tkanki guza do analizy.
✗ Disqualifies
- •Brak danych w dostarczonym tekście dotyczących kryteriów wykluczenia.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- June 15, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, China
Trial contact
Hongxia Wang
Ting Li
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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