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Could a Three-Drug combo beat back recurrent breast cancer?

NCT ID NCT06976944

Disease control Sponsor: Yukinori Ozaki 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Updated 2 times

Summary

This study is for people with a type of breast cancer called triple-negative that has come back after treatment. The researchers want to see if adding a drug called bevacizumab to the usual combination of pembrolizumab and paclitaxel works better. About 44 adults who have already received immunotherapy will take part. The goal is to find a more effective treatment option.

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 24 people

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

Started

Jun 2025

Expected to finish

Sep 2029

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.

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. Male/female participants who are 18 years of age or older on the day of signing informed consent with histologically or cytologically confirmed diagnosis of invasive breast cancer will be enrolled in this study. 2. Participants have been confirmed to be ER negative, HER2 negative according to the latest ASCO/CAP criteria. However, it does not matter whether the result is positive or negative for PgR. 3. Participants have been confirmed to be PD-L1 positive in each site's evaluation using biopsy specimen or surgical specimen. 4. Participants who have received not more than 1 prior chemotherapy regimen (including those with no prior chemotherapy) for recurrent breast cancer, excluding trial drugs of this clinical trial. (Participants with prior paclitaxel or bevacizumab for recurrent breast cancer are excluded.) However, prior treatment with Olaparib for metastatic recurrence or unresectable advanced cancer in participants with BRCA gene pathogenic variant is allowed (not counted as 1 regimen). 5. Participants must have recurred after treatment with an anti-PD-1/PD-L1 antibody administered as monotherapy or in combination with other ICIs or chemotherapies as a perioperative drug therapy for triple negative breast cancer. 6. Have an Eastern Cooperative Oncology Group performance status of 0 to 1. Exclusion Criteria: 1. Participants with progressive disease on RECIST or clinically diagnosed during preoperative ICI and chemotherapy. 2. Known additional malignancy that is progressing or has required active treatment within the past 3 years prior to enrollment. 3. Has known active CNS metastases and/or carcinomatous meningitis. 4. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.

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Conditions

The condition(s) this trial relates to.

breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

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

Recurrent triple-negative breast cancer

How to take part

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

  1. The places running it

    14 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 Institute Hospital of JFCR

    RECRUITING

    Koto-ku, Tokyo, 135-8550, Japan

  • Gifu University Hospital

    RECRUITING

    Gifu, Gifu, 501-1194, Japan

  • Hiroshima University Hospital

    RECRUITING

    Hiroshima, Hiroshima, 734-8551, Japan

  • Hokkaido University Hospital

    RECRUITING

    Sapporo, Hokkaido, 060-8648, Japan

  • Hyogo Cancer Center

    RECRUITING

    Akashi-shi, Hyōgo, 673-8558, Japan

  • Kindai University Hospital

    RECRUITING

    Sakai-shi, Osaka, 590-0197, Japan

  • Nagoya City University Hospital

    RECRUITING

    Nagoya, Aichi-ken, 467-8602, Japan

  • Nagoya University Hospital

    RECRUITING

    Nagoya, Aichi-ken, 466-8560, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Hospital Organization Nagoya Medical Center

    RECRUITING

    Nagoya, Aichi-ken, 460-0001, Japan

  • Okayama University Hospital

    RECRUITING

    Okayama, Okayama-ken, 700-8558, Japan

  • Osaka International Cancer Institute

    RECRUITING

    Osaka, Osaka, 541-8567, Japan

  • Osaka Metropolitan University Hospital

    RECRUITING

    Osaka, Osaka, 545-0051, Japan

  • SHOWA Medical University Hospital

    RECRUITING

    Shinagawa-ku, Tokyo, 142-8666, Japan