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Can a targeted drug extend life in Hard-to-Treat breast cancer?

NCT ID NCT06993506

Disease control Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This study looks at how well sacituzumab tirumotecan (SKB264) works, either alone or with other treatments, in people with advanced HER2-negative breast cancer that has spread or come back. It includes two groups: those with triple-negative breast cancer and those with hormone receptor-positive, HER2-negative disease. The goal is to see how long patients go before needing a different treatment and to check the drug's safety in everyday clinical practice.

What this could mean

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

Active substance
Sacituzumab tirumotecan (SKB264) given alone or with other drugs
What this could lead to
If successful, this could provide a new treatment option for advanced HER2-negative breast cancer, potentially improving how long patients live without the disease progressing.
What could go wrong
This is an observational study, so it cannot prove the drug works better than existing treatments. Results may vary in real-world settings, and side effects are possible.

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.

Participants

About 500 people

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

Started

May 2026

Expected to finish

Oct 2027

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.

Who is studied

Patients with Unresectable Locally Advanced, Recurrent or Metastatic HER2-Negative Breast Cancer

Ages

18 years and older

Sex

Anyone

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: 1. Aged ≥ 18 years old at the time of signing the informed consent form, regardless of gender; 2. Patient must meet one of the following pathological diagnoses and classifications: 2.1) For TNBC Cohort: -Histological/cytological confirmed of triple-negative breast cancer (TNBC) from the most recent pre-SKB264 biopsy/pathological report, with: HER2 negative: immunohistochemistry (IHC) of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by fluorescence in situ hybridization (FISH); Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC; -Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection); 2.2) For HR+/HER2- BC Cohort: -Histological/cytological confirmed of HR+/HER2- breast cancer from the most recent pre-SKB264 biopsy/pathological report, with: HER2 negative: IHC of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by FISH; HR positive: Hormone receptor-positive (HR, ER, or PR status) was defined as ≥1% expression by IHC.-Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection); 3. Plan to receive SKB264 monotherapy or combination therapy; 4. Prior treatment lines: -For TNBC Cohort: ≤2 lines of systemic antitumor therapy for unresectable locally advanced, recurrent, or metastatic disease; -For HR+/HER2- BC Cohort: ≤2 lines of systemic antitumor therapy (excluding endocrine therapy) for unresectable locally advanced, recurrent, or metastatic disease; 5. Voluntarily participate in the study, sign the informed consent form and demonstrate good compliance. Exclusion Criteria: 1. Patients with other malignancies, except cured basal or squamous cell skin cancer or in situ cancer of cervix; and patients with other malignancies must have a tumor-free period of at least 5 years; 2. Patients who are currently participating in other interventional clinical studies; 3. Known allergy to the investigational drug or any of its components; 4. Pregnant or lactating women; 5. Any situation that the researchers consider to interfere with the evaluation of the study drug or the safety of the subjects or the analysis of the study results, or any other situation that the researchers consider inappropriate to participate in this study.

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Conditions

The condition(s) this trial relates to.

Her2-receptor negative breast cancer hormone receptor-positive breast cancer metastatic neoplasm Neoplasm Metastasis Recurrence triple-negative breast carcinoma

As listed by the trial registrant

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

HER2-negative breast cancer Metastasis Recurrence

How to take part

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

  1. The places running it

    19 sites. 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

  • Cancer Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • Chinese PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100853, China

  • Fujian Cancer Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, 350000, China

  • Hubei Cancer Hospital

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430079, China

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • Shanxi Bethune Hospital

    RECRUITING

    Taiyuan, Shanxi, 030032, China

  • Suining Central Hospital

    RECRUITING

    Suining, Sichuan, 629000, China

  • Taihe Hospital

    RECRUITING

    Shiyan, Hubei, 442099, China

  • The Affiliated People's Hospital of Ningbo University

    RECRUITING

    Ningbo, Zhejiang, 315100, China

  • The First Affiliated Hospital of Xiamen University

    NOT_YET_RECRUITING

    Xiamen, Fujian, China

  • The First Affiliated Hospital of Zhengzhou University

    NOT_YET_RECRUITING

    Zhengzhou, Henan, China

  • The First People's Hospital of Changde City

    RECRUITING

    Changde, Hunan, 415003, China

  • The Fourth Hospital of Hebei Medical University

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, China

  • The Second Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230601, China

  • The Third People's Hospital of Zhengzhou

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450000, China

  • The first hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130021, China

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430022, China

  • Yantai Yuhuangding Hospital

    RECRUITING

    Yantai, Shandong, 264000, China

  • Zhongshan Hospital Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.