Breast cancer study pulled before it began: new combo never tested
NCT ID NCT06829199
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 However, the study was withdrawn before enrolling any participants, so no results are available.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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
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Mar 2025
An estimate. Start dates often move.
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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National Cheng Kung University Hospital ( Site 0901)
Tainan, 704, Taiwan
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Optum Care Cancer Center ( Site 0004)
Las Vegas, Nevada, 89102, United States