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Trastuzumab Deruxtecan Plus ivonescImab for Hormone Receptor-positive HER2 Negative Advanced Breast Cancer Study

NCT07647016 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-06-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Trastuzumab Deruxtecan and ivonescimab

* Trastuzumab Deruxtecan (T-DXd): Administered at a dose of 5.4 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle. * Ivonescimab: Administered at a dose of 20 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle. Treatment for both agents will continue until disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-12-30
Completion
2028-02-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07647016 on ClinicalTrials.gov