Sacituzumab Tirumotecan Plus Tagitanlimab in Previously Treated Locally Advanced or Metastatic Triple Negative Breast Cancer

Not Applicable

Not yet recruiting

• Conditions: Triple Negative Breast Cancer (TNBC); PD-L1 Positive
• Interventions: Drug: Sacituzumab Tirumotecan plus Tagitanlimab

• Registration Number: NCT07153965
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

This is an open-label, single-arm, multicenter phase II study to evaluate the safety and efficacy of sac-TMT plus Tagitanlimab in patients with PD-L1-positive locally advanced or metastatic TNBC.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-24
• Study First Submitted QC: 2025-08-31
• Last Update Submitted: 2025-08-31
• Study Start: 2025-09-01
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sac-TMT plus Tagitanlimab	Sacituzumab Tirumotecan plus Tagitanlimab	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	up to approximately 60 months	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) as Assessed by Investigator per RECIST Version 1.1	up to approximately 60 months	PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.
Overall Survival (OS)	up to approximately 60 months	OS is defined as the time from randomization until the date of death from any cause.
Disease control response (DCR) as Assessed by Investigator per RECIST Version 1.1	up to approximately 60 months	DCR is defined as the proportion of participants who achieve a complete response (CR), partial response (PR) or or stable disease (SD) .
Safety and Tolerability	up to approximately 60 months	Incidence and severity of AEs and SAEs (per CTCAE 5.0)
Duration of response (DoR)	up to approximately 60 months	DoR is defined as the time from the first objective response (CR/PR) to the first documented disease progression (PD) according to RECIST v1.1 or death from any cause, whichever comes first.
Health-related quality of life (HRQoL) evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	up to approximately 60 months	Mean change from baseline in the EORTC QLQ-C30
Health-related quality of life (HRQoL) evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module 23 (EORTC QLQ-BR23)	up to approximately 60 months	Mean change from baseline in the EORTC QLQ-BR23

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin Municipality, China