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Breast cancer study pulled before it began: new combo never tested

NCT ID NCT06829199

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 study was designed to test whether adding the experimental drug boserolimab to standard chemotherapy and immunotherapy before surgery could help people with high-risk, early-stage triple-negative breast cancer. The goal was to see if the combination was safe and could eliminate all signs of cancer in the breast and lymph nodes at the time of surgery. However, the study was withdrawn before enrolling any participants, so no results are available.

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.

Expected to start

Mar 2025

An estimate. Start dates often move.

Expected to finish

Mar 2031

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 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: The main inclusion criteria include but are not limited to the following: * Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as tumor stage T1c, nodal stage N1-2, or tumor stage T2-4, nodal stage N0-2 * Has provided a core needle biopsy for tissue diagnosis of the current breast cancer less than 29 days prior to the date of informed consent * Has centrally confirmed diagnosis of BC that is triple-negative based on the American Society of Clinical Oncology/College of American Pathologists guidelines * Has Eastern Cooperative Oncology Group performance status of 0 or 1 performed within 28 days before treatment randomization * Has left ventricle ejection fraction of ≥50% as assessed by echocardiogram or multigated acquisition scan performed at screening * Has a history of exposure to anthracycline; participants can be eligible after completion of a Sponsor consultation form, if cumulative lifetime doses are as follows: Doxorubicin \<100 mg/m2, Epirubicin \<180 mg/m2, Mitoxantrone \<40 mg/m2, Idarubicin \<22.5 mg/m2. Note: If another anthracycline or more than one anthracycline has been used, the cumulative dose must not exceed the equivalent of 100 mg/m2 of doxorubicin Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has documented Grade ≥2 peripheral neuropathy * Has uncontrolled or significant cardiovascular disease * Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein-4 \[CTLA-4\], OX-40 \[cluster of differentiation (CD) 134\], or CD137) * Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer * Has received prior systemic anticancer therapy * Has undergone excisional biopsy of the primary tumor and/or axillary lymph node dissection prior to study treatment * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention * Has a known additional malignancy that is progressing or has required active treatment within the past 5 years * Has active autoimmune disease that has required systemic treatment in the past 2 years with need for disease modifying agents such as corticosteroids or immunosuppressive drugs * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has an active infection requiring systemic therapy * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has severe hypersensitivity (Grade ≥3) to pembrolizumab, any investigational agent or study intervention, any of its excipients, and/or to another biologic therapy * Has a history of allogeneic tissue/solid organ transplant

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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

  • National Cheng Kung University Hospital ( Site 0901)

    Tainan, 704, Taiwan

  • Optum Care Cancer Center ( Site 0004)

    Las Vegas, Nevada, 89102, United States