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New combo aims to tackle tough breast cancer

NCT ID NCT07040644

Disease control Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial tests whether combining the targeted chemotherapy sacituzumab govitecan with the immunotherapy toripalimab works better than toripalimab plus standard chemotherapy (nab-paclitaxel) for people with advanced triple-negative breast cancer that is PD-L1 positive. About 150 participants will be randomly assigned to one of the two treatment groups. The main goal is to see how long the cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sacituzumab govitecan (a targeted chemotherapy) and toripalimab (an immunotherapy), compared with toripalimab plus nab-paclitaxel (a standard chemotherapy)
What this could lead to
If this works, it could offer a more effective first-line treatment option for people with advanced triple-negative breast cancer that is PD-L1 positive.
What could go wrong
This is a phase 2 trial with only 150 participants, so results are preliminary. The combination may not improve survival and could cause side effects like immune reactions or low blood cell counts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Triple negative breast neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Guangzhou, Guangdong, 510120, China

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