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New hope for breast cancer brain metastases? drug combo trial launches

NCT ID NCT05872347

Disease control Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests a new oral drug called SPH4336 combined with standard hormone therapy for people with HR-positive, HER2-negative breast cancer that has spread to the brain. The study aims to see if the combination can shrink brain tumors and control the disease. About 52 participants will be enrolled, and the main focus is on how well the treatment works inside the brain.

What this could mean

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

Active substance
SPH4336 (a targeted drug taken orally) combined with endocrine therapy (letrozole, fulvestrant, or exemestane)
What this could lead to
If successful, this could offer a new treatment option for people with HR-positive, HER2-negative breast cancer that has spread to the brain, potentially shrinking or controlling brain tumors.
What could go wrong
This is an early Phase 2 trial with only 52 participants, so results may not apply to everyone. The drug may cause side effects or fail to improve outcomes compared to existing treatments.

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 52 people

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

Started

Sep 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 75 years

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: 1. Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF). 2. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1. 3. Life expectancy ≥ 3 months. 4. Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies. 5. At least one measurable lesion . 6. Laboratory test results meet the relevant requirements for organ function. 7. Subjects who agree to take effective contraceptive measures. Exclusion Criteria: 1. Inflammatory breast cancer. 2. Patients unsuitable for endocrine therapy at the investigator's discretion. 3. Have a History of other malignancies prior to the start of study treatment. 4. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF. 5. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery. 6. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment. 7. Pregnant or lactating women. 8. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; ≥ NYHA (New York Heart Association) Class II; QTcF≥ 470 ms; left ventricular ejection fraction ≤ 50%. 9. History of ischemic stroke or severe thromboembolic disease before the start of study treatment. 10. Hepatitis B surface antigen positive and HBV (Hepatitis B Virus) DNA \> 2,000 IU/mL or \> 10(4) copies/mL; HCV (Hepatitis C Virus) antibody positive and HCV RNA positive; or known HIV infection. 11. History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product. 12. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment. 13. Presence of uncontrolled infections before the start of study treatment. 14. Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders. 15. Presence of other diseases that the risks of receiving the study treatment outweigh its benefits, as determined by the investigator, or any other reason for which patients are ineligible for the study as assessed by the investigator.

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Conditions

The condition(s) this trial relates to.

hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast cancer brain metastases

How to take part

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

  1. The places running it

    25 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

  • Affiliated Cancer Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • Anhui provincial hospital

    RECRUITING

    Hefei, Anhui, 230002, China

  • Anyang Cancer Hospital

    RECRUITING

    Anyang, He'nan, 455001, China

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, China

  • Cancer Hospital of Xinjiang Medical University

    RECRUITING

    Ürümqi, Xinjiang, 830054, China

  • Chongqing University Three Gorges Hospital

    RECRUITING

    Chongqing, 404031, China

  • General Hospital of Ningxia Medical University

    RECRUITING

    Yinchuan, Ningxia, 750003, China

  • Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute

    RECRUITING

    Nanning, China

  • Harbin Medical University cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150081, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Jilin Cancer Hospital

    RECRUITING

    Changchun, Jilin, 130012, China

  • Liuzhou people's Hospital

    RECRUITING

    Liuzhou, Guangxi, 545026, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, 100730, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Bengbu Medical College

    RECRUITING

    Bengbu, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    RECRUITING

    Luoyang, He'nan, 450052, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050011, China

  • The first hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130061, China

  • The second people's hospital of neijiang

    RECRUITING

    Neijiang, Sichuan, 641199, China

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, China

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

    RECRUITING

    Wuhan, China

  • Xi'An International Medical Cancer Hospital

    RECRUITING

    Xi'an, China

  • Xiangyang Central Hospital

    RECRUITING

    Xiangyang, Hubei, 441021, China

  • Zhejiang cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310005, China