Sacituzumab Govitecan + Toripalimab as First - Line Thera... | NCT06991790

Studies
Sacituzumab Govitecan + Toripalimab as First - Line Therapy for Advanced Triple - Negative Breast Cancer and Biomarker Exploration

NCT06991790

Sponsor

Peking University Cancer Hospital & Institute

Status

Recruiting

Last Update Posted

May 28, 2025Actual

Enrollment

51Estimated

Phase

Not provided

Conditions

TNBC

Interventions

Sacituzumab Govitecan (SG)+Toripalimab

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2025Actual

Primary Completion Date

May 1, 2027Estimated

Completion Date

May 1, 2028Estimated

First Submitted Date

May 7, 2025

First Submission Date that Met QC Criteria

May 18, 2025

First Posted Date

May 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2025

Last Update Posted Date

May 28, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

songguohong, Chief Physician, Deputy Director of the Department, Medical Oncology of Breast Cancer, Peking University Cancer Hospital & InstitutePrincipal Investigator

Lead Sponsor

Peking University Cancer Hospital & InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this study is to explore the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment in patients with advanced triple - negative breast cancer.

The main questions it aims to answer are:

To investigate the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer.
To explore the biomarkers that can predict the efficacy of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer.

Participants will:

Have their progression - free survival (PFS) observed and evaluated. Have all adverse events and immune - related adverse events monitored to assess safety.

Have their objective response rate measured as a secondary outcome. Have their survival period tracked as a secondary outcome. Have biomarkers associated with efficacy observed and explored as a secondary outcome.

Detailed Description

1. Research Objectives： The overall objective of this study is to explore the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer.

Primary Objectives：1）To observe and evaluate the efficacy (progression - free survival, PFS) of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer under real - world conditions.2）To observe and evaluate the safety (all adverse events and immune - related adverse events) of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer under real - world conditions. Secondary Objectives：Objective response rate.Survival.To observe and explore biomarkers associated with efficacy. 2. Significance of the Research：Currently, chemotherapy remains the main treatment for advanced triple - negative breast cancer. However, whether it is single - agent or combination chemotherapy, the efficacy is rather poor. Improving the efficacy and safety of first - line treatment for advanced triple - negative breast cancer is an urgent problem to be solved. Both sacituzumab govitecan and toripalimab are major drugs for the treatment of advanced triple - negative breast cancer, and combination therapy may further enhance the effectiveness of treatment. At present, there is no literature reporting the efficacy and safety data of sacituzumab govitecan in combination with toripalimab as first - line treatment. This study is a prospective, single - arm, multicenter, non - interventional, observational clinical trial, aiming to observe the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer in the real world.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

51Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sacituzumab govitecan combined with Toripalimab			Drug: Sacituzumab Govitecan (SG)+Toripalimab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sacituzumab Govitecan (SG)+Toripalimab	Drug	Sacituzumab govitecan (Trodelvy): 10mg/kg, administered by intravenous infusion on day 1 and day 8. Toripalimab: 240mg, administered by intravenous infusion on day 1.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD) or death (whichever comes first).	Enrollment up for approximately 36 months.

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS is defined as the time from the date of randomization until death due to any cause.	Enrollment up for approximately 53 months.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female breast cancer patients aged 18 to 75 years old;
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0 to 1;
Patients with histologically or cytologically confirmed advanced triple-negative breast cancer;
Patients who have not received systemic treatment (including chemotherapy, targeted therapy and immunotherapy) for advanced triple-negative breast cancer;
According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard, having at least one measurable lesion;
Deciding to receive anti-tumor treatment with the combination of sacituzumab govitecan and toripalimab.

Exclusion Criteria:

Patients with symptomatic brain metastases (such as increased intracranial pressure, epilepsy, etc.) who require emergency radiotherapy or surgical intervention;
Patients who have previously received HER2-targeted therapy or Trop-2-targeted therapy;
Patients who have previously used or are currently using PD-(L)1 inhibitors and/or ADC drugs containing topoisomerase inhibitors, such as sacituzumab govitecan, Dato-DXd, etc., as well as topoisomerase inhibitors;
Patients who are considered by the investigator to be unsuitable for participating in this study.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients receiving first-line treatment for advanced triple-negative breast cancer

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Guohong Song, Doctor of Medicine (M.D.)	Contact	0086-88121122-2066		songguohong918@hotmail.com

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Cancer Hospital	Recruiting	Beijing		100142	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001943	Breast Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases