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

NCT ID NCT06570031

Disease control Sponsor: Ono Pharmaceutical Co., Ltd. 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

46 people

The number who actually took part.

Started

Nov 2021

Finished

Apr 2026

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

20 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: 1. Patients with postmenopausal metastatic or recurrent breast cancer 2. Patients with ECOG Performance Status 0 to 1 3. ER-positive, PgR-positive and HER2-negative patients Exclusion Criteria: 1. Patients are unable to swallow oral medications 2. Patients with severe complication

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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

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