TNBCNCT06991790
Sacituzumab Govitecan + Toripalimab as First - Line Therapy for Advanced Triple - Negative Breast Cancer and Biomarker Exploration
An observational study of TNBC, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- TNBC
- What is being tested?
- Sacituzumab Govitecan (SG)+Toripalimab
- Type of treatment
- Injection or infusion
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving first-line treatment for advanced triple-negative breast cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, 100142
Guohong Song, Doctor of Medicine (M.D.), 0086-88121122-2066, songguohong918@hotmail.com
About this study
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
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:
Read more
- 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.
Read the detailed description
- 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.
- Conditions
- TNBC
- Being tested
- Sacituzumab Govitecan (SG)+Toripalimab
- Keywords
- sacituzumab govetican, toripalimab, ADC, triple-negative breast cancer, first-line therapy, immune-checkpoint inhibitor
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Govitecan (SG)+ToripalimabDrug
Also called IMMU-132, Trodelvy™, GS-0132, Toripalimab
Sacituzumab govitecan (Trodelvy): 10mg/kg, administered by intravenous infusion on day 1 and day 8.
Toripalimab: 240mg, administered by intravenous infusion on day 1.
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab govitecan combined with Toripalimab | Not described Receives: Drug: Sacituzumab Govitecan (SG)+Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Enrollment up for approximately 36 months.
Secondary outcomes (4)
Overall Survival (OS)
OS is defined as the time from the date of randomization until death due to any cause.
Measured: Enrollment up for approximately 53 months.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: First dose date up to 30 days post last dose, up to approximately 53 months
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
ORR is defined as the proportion of participants who achieve complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Measured: Enrollment up for approximately 53 months.
Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities
Measured: First dose date up to 30 days post last dose, up to approximately 53 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, songguohong, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991790
- Sponsor's protocol ID
- Y-Gilead2024-ZD-0212
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06991790
- Acronym / sponsor ID
- Y-Gilead2024-ZD-0212
- Conditions
- TNBC
- Keywords
- sacituzumab govetican, toripalimab, ADC, triple-negative breast cancer, first-line therapy, immune-checkpoint inhibitor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab govitecan combined with Toripalimab | – | Drug: Sacituzumab Govitecan (SG)+Toripalimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving first-line treatment for advanced triple-negative breast cancer
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab Govitecan (SG)+ToripalimabAlso: IMMU-132, Trodelvy™, GS-0132, ToripalimabSacituzumab govitecan (Trodelvy): 10mg/kg, administered by intravenous infusion on day 1 and day 8. Toripalimab: 240mg, administered by intravenous infusion on day 1. | Drug | Sacituzumab govitecan combined with Toripalimab |
Primary outcome
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Enrollment up for approximately 36 months.
PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD) or death (whichever comes first).
4 secondary outcomes
Overall Survival (OS)
Time frame: Enrollment up for approximately 53 months.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: First dose date up to 30 days post last dose, up to approximately 53 months
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Time frame: Enrollment up for approximately 53 months.
Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities
Time frame: First dose date up to 30 days post last dose, up to approximately 53 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TNBC, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guohong Song, Doctor of Medicine (M.D.) (0086-88121122-2066, songguohong918@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (time frame: Enrollment up for approximately 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.