Clinical trial NCT06991790: Sacituzumab Govitecan + Toripalimab as First - Line Therapy for Advanced Triple - Negative Breast Cancer and Biomarker Exploration
Official title: A Prospective, Single-arm, Multicenter Phase II Clinical Study of Sacituzumab Govitecan in Combination With Toripalimab as First-line Treatment for Advanced Triple-negative Breast Cancer and an Exploratory Study of Biomarkers for Predicting Efficacy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: TNBC
Keywords: sacituzumab govetican
toripalimab
ADC
triple-negative breast cancer
first-line therapy
immune-checkpoint inhibitor
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving first-line treatment for advanced triple-negative breast cancer

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:

1. To investigate the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer.
2. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with symptomatic brain metastases (such as increased intracranial pressure, epilepsy, etc.) who require emergency radiotherapy or surgical intervention;
2. Patients who have previously received HER2-targeted therapy or Trop-2-targeted therapy;
3. 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;
4. Patients who are considered by the investigator to be unsuitable for participating in this study.

Primary outcomes:
measure: Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
timeFrame: Enrollment up for approximately 36 months.
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Enrollment up for approximately 53 months.
measure: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: First dose date up to 30 days post last dose, up to approximately 53 months
measure: Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
timeFrame: Enrollment up for approximately 53 months.
measure: Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities
timeFrame: First dose date up to 30 days post last dose, up to approximately 53 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
References: