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

NCT ID NCT05872347

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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