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New combo therapy for advanced breast cancer shows promise in early trial

NCT ID NCT06570031

Completed Disease control Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a new drug called ONO-4578 combined with standard hormone therapy and targeted drugs (letrozole plus palbociclib or abemaciclib) in 46 postmenopausal women with advanced or recurrent hormone receptor-positive, HER2-negative breast cancer. The main goal was to check the safety and tolerability of the combination. Researchers also looked at how well the cancer responded to treatment, such as tumor shrinkage and how long it stayed controlled.

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Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

HER2-NEGATIVE BREAST CANCER HORMONE RECEPTOR POSITIVE BREAST CANCER METASTATIC BREAST CANCER RECURRENT BREAST CANCER

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, Japan

  • Chiba Cancer Center

    Chiba, Chiba, Japan

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, Japan

  • Nagoya University Hospital

    Nagoya, Aichi-ken, Japan

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, Japan

  • Osaka International Cancer Institute

    Osaka, Osaka, Japan

  • Saitama Cancer Center

    Shinden, Saitama, Japan

  • St. Marianna University Hospital

    Kawasaki-shi, Kanagawa, Japan

  • The Cancer Institute Hospital Of JFCR

    Koto-ku, Tokyo, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, Japan

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, Japan

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, Japan

More trials for these conditions

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