Lucentis Plus Tagolimumab in PD-L1+, HR+/HER2- Advanced Breast Cancer After CDK4/6 Inhibitors

NCT07258108 | Not Yet Recruiting Phase 2

• 1 other identifier: SYSU-2025
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II single-arm study designed to evaluate the efficacy and safety of Lucanisatuzumab + Tagolisumab in 35 patients with PD-L1+ HR+/HER2- advanced breast cancer who failed prior CDK4/6 inhibitor therapy. The primary endpoint is the 6-month PFS rate. Treatment will continue until disease progression or intolerable toxicity, with periodic imaging assessments and survival follow-up.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• progression-free survival rate (PFS)

  The proportion of subjects who remained free of radiographic disease progression or death within 6 months of receiving the first dose of study treatment, relative to the total number of subjects.

  6 months

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  1 year

• Progression-Free Survival (PFS)

  1 year

• Disease Control Rate (DCR)

  1 year

• Duration of Response (DoR)

  1 year

• Overall survival (OS)

  1 year

Study Arms (1)

Lucanisatuzumab plus Tagolimumab

EXPERIMENTAL

Lucanisatuzumab (5 mg/kg, Q2W) in combination with tagolimumab (900 mg, Q2W) administered intraveno

Drug: Lucanisatuzumab plus tagolimumab

Interventions

Lucanisatuzumab plus tagolimumab DRUG

Each participant receives Lucanisatuzumab plus tagolimumab intravenously.

Lucanisatuzumab plus Tagolimumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old.
• HR+/HER2- breast cancer (BC), meeting the following conditions:
• HR+/HER2-; HER2-(IHC 0 or 1+); IHC 2+(FISH negative); HR+ (ER and/or PR IHC showed ≥1%);
• Tumor stage: Locally advanced, recurrent, or metastatic HR+/HER2- breast cancer; 3) Disease progression during or within 12 months after completion of adjuvant endocrine therapy based on a CDK4/6 inhibitor, or disease progression on CDK4/6 inhibitor treatment for metastatic disease; 4) PD-L1 positive (CPS ≥ 1); 5) At least one measurable target lesion as assessed by the investigator per RECIST 1.1; subjects with bone lesions only

You may not qualify if:

• Received chemotherapy during the advanced stage;
• Received any targeted therapy against topoisomerase I during the advanced stage, including antibody-drug conjugates (ADCs) (e.g., anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies), or any immune cell therapy targeting
• Received immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibodies) in the advanced stage;
• Recurrence or metastasis within 12 months of the last chemotherapy in the early stage;
• Subjects with central nervous system (CNS) metastases. For subjects with brain metastases who have previously received local therapy,
• Other malignancies within 5 years prior to dosing (excluding locally treated and cured tumors such as basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ);

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, Chile

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fei Xu, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Xu, MD

CONTACT

+86-13711277870; xufei@sysucc.org.cn

Kuikui Jiang, MD

CONTACT

+86-15210589011; jiangkk@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: November 21, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)