Triple Negative Breast NeoplasmsPhase 2NCT07040644

A Study of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel in PD-L1 Positive Advanced TNBC

A Phase 2 study testing Sacituzumab Govitecan (SG), Toripalimab and Nab-paclitaxel in people with Triple Negative Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This is a multicenter, open-label, randomized phase II trial evaluating the efficacy and safety of sacituzumab govitecan plus toripalimab versus toripalimab plus nab-paclitaxel in patients with previously untreated, unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) that is PD-L1… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Triple Negative Breast Neoplasms
What is being tested?: Sacituzumab Govitecan (SG), Toripalimab and Nab-paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteChina
Study dates: Sep 2025to Jun 2028
Phase: Phase 2
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female patients aged ≥18 years.
Histologically or cytologically confirmed triple-negative breast cancer (TNBC).
Unresectable locally advanced or metastatic disease.
PD-L1 positive (CPS ≥1 as assessed by central laboratory).
No prior systemic treatment for advanced or metastatic TNBC.
Measurable disease per RECIST v1.1.

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ECOG performance status of 0 or 1.
Adequate hematologic, hepatic, and renal function.
Willingness to provide informed consent.

Who cannot join

Prior treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
Known active central nervous system metastases.
Active autoimmune disease or history of autoimmune disorders requiring systemic treatment.
Active infection requiring systemic therapy.
Pregnancy or lactation.
Other active malignancies requiring treatment within the past 5 years.
History of severe hypersensitivity reactions to study drugs.

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

Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510120
Sun Yat-sen Memorial Hospital of Sun Yat-sen University, +86 20 8133 2536, jiangzefei@csco.org.cn

Other trials in China

About this study

Official title: A Multi-center, Open-label, Randomized, Phase II Trial of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel as First-line Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer

Eligible patients will be randomized in a 1:1 ratio to receive either sacituzumab govitecan plus toripalimab or toripalimab plus nab-paclitaxel. Tumor response will be assessed by investigators according to RECIST v1.1 at baseline, every 6 weeks during the first year, and every 12 weeks thereafter.

The primary objective is to evaluate progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to response (TTR), and safety profile according to NCI-CTCAE v5.0.

Conditions: Triple Negative Breast Neoplasms
Being tested: Sacituzumab Govitecan (SG), Toripalimab, Nab-paclitaxel
Keywords: PD-L1 Positive, Sacituzumab Govitecan, Toripalimab, Nab-Paclitaxel, Advanced Breast Cancer, Metastatic TNBC, Randomized Controlled Trial, Progression-Free Survival
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)Drug
Sacituzumab govitecan will be administered at 10 mg/kg via intravenous infusion on Days 1 and 8 of each 21-day cycle. The treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.
ToripalimabDrug
Toripalimab will be administered at a fixed dose of 240 mg via intravenous infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.
Nab-paclitaxelDrug
Nab-paclitaxel will be administered at 125 mg/m² via intravenous infusion on Days 1 and 8 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.

Study groups in NCT07040644
Study group	Role	What they receive
SG plus Toripalimab	Experimental	Participants will receive sacituzumab govitecan at 10 mg/kg via IV infusion on Days 1 and 8 of each 21-day cycle, and toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal. Receives: Drug: Sacituzumab Govitecan (SG); Drug: Toripalimab
Nab-Paclitaxel plus Toripalimab	Active comparator	Participants will receive toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle, and nab-paclitaxel at 125 mg/m² via IV infusion on Days 1 and 8 of each cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal. Receives: Drug: Toripalimab; Drug: Nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as assessed by investigators based on RECIST version 1.1 criteria.
Measured: From randomization until disease progression or death, assessed up to 36 months

Secondary outcomes (5)

Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to death from any cause. The event will be recorded regardless of cause and assessed continuously until the end of study follow-up.
Measured: From randomization until death, assessed up to 48 months
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR), confirmed at least 4 weeks after the initial response, as assessed by investigators according to RECIST version 1.1 criteria.
Measured: From first dose to first confirmed response, assessed up to 36 months
Duration of Response (DOR)
Duration of Response (DOR) is defined as the time from the first documentation of complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurs first, as assessed by investigators according to RECIST version 1.1 criteria.
Measured: From first response until progression or death, assessed up to 36 months
Time to Response (TTR)
Time to Response (TTR) is defined as the time from randomization to the first documentation of complete response (CR) or partial response (PR), as assessed by investigators according to RECIST version 1.1 criteria.
Measured: From randomization to first response, assessed up to 36 months
Incidence of Adverse Events and Serious Adverse Events
Incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) will be assessed from the first dose through 30 days after the last dose, and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Measured: From first dose until 30 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2025Jun 2028

First posted27 Jun 2025
Study startSep 2025 (estimated)
Primary completionJun 2027 (estimated)
Study completionJun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Triple Negative Breast NeoplasmsStudies of the same condition, open and under way.
More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07040644
Sponsor's protocol ID: CO-US-979-7331
Status last verified: May 2025
First submitted: 19 Jun 2025
Last updated: 8 Sep 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Open-label, Randomized, Phase II Trial of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel as First-line Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer
ClinicalTrials.gov ID: NCT07040644
Acronym / sponsor ID: CO-US-979-7331
Conditions: Triple Negative Breast Neoplasms
Keywords: PD-L1 Positive, Sacituzumab Govitecan, Toripalimab, Nab-Paclitaxel, Advanced Breast Cancer, Metastatic TNBC, Randomized Controlled Trial, Progression-Free Survival
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 150 participants (estimated)
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
Study start: Sep 2025 (estimated)
Primary completion: Jun 2027 (estimated)
Study completion: Jun 2028 (estimated)
First posted: 27 Jun 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SG plus Toripalimab	Experimental	Drug: Sacituzumab Govitecan (SG), Drug: ToripalimabParticipants will receive sacituzumab govitecan at 10 mg/kg via IV infusion on Days 1 and 8 of each 21-day cycle, and toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.
Nab-Paclitaxel plus Toripalimab	Active comparator	Drug: Toripalimab, Drug: Nab-paclitaxelParticipants will receive toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle, and nab-paclitaxel at 125 mg/m² via IV infusion on Days 1 and 8 of each cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Female patients aged ≥18 years.
Histologically or cytologically confirmed triple-negative breast cancer (TNBC).
Unresectable locally advanced or metastatic disease.
PD-L1 positive (CPS ≥1 as assessed by central laboratory).
No prior systemic treatment for advanced or metastatic TNBC.

Key exclusion criteria (7 listed)

Prior treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
Known active central nervous system metastases.
Active autoimmune disease or history of autoimmune disorders requiring systemic treatment.
Active infection requiring systemic therapy.
Pregnancy or lactation.

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)Sacituzumab govitecan will be administered at 10 mg/kg via intravenous infusion on Days 1 and 8 of each 21-day cycle. The treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.	Drug	SG plus Toripalimab
ToripalimabToripalimab will be administered at a fixed dose of 240 mg via intravenous infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.	Drug	Nab-Paclitaxel plus Toripalimab, SG plus Toripalimab
Nab-paclitaxelNab-paclitaxel will be administered at 125 mg/m² via intravenous infusion on Days 1 and 8 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.	Drug	Nab-Paclitaxel plus Toripalimab

Primary outcome

Progression-Free Survival (PFS)
Time frame: From randomization until disease progression or death, assessed up to 36 months
Progression-Free Survival (PFS) is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as assessed by investigators based on RECIST version 1.1 criteria.

5 secondary outcomes

Overall Survival (OS)
Time frame: From randomization until death, assessed up to 48 months
Objective Response Rate (ORR)
Time frame: From first dose to first confirmed response, assessed up to 36 months
Duration of Response (DOR)
Time frame: From first response until progression or death, assessed up to 36 months
Time to Response (TTR)
Time frame: From randomization to first response, assessed up to 36 months
Incidence of Adverse Events and Serious Adverse Events
Time frame: From first dose until 30 days after last dose

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 8 Sep 2025.

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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.

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, China

+86 20 8133 2536

jiangzefei@csco.org.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 7 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: opening soon, as of the sponsor's last update on 8 Sep 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: From randomization until disease progression or death, assessed up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07040644.

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 8 Sep 2025.