Early Triple Negative Breast CancerPhase 2NCT06829199
A Clinical Study of Boserolimab (MK-5890) With Pembrolizumab and Chemotherapy in People With Early Triple-Negative Breast Cancer (MK-5890-003)
A Phase 2 study testing Pembrolizumab, Paclitaxel and Carboplatin in people with Early Triple Negative Breast Cancer, run by Merck Sharp & Dohme LLC at 2 sites in 2 countries.
Trial summary
Researchers want to learn if giving boserolimab (MK-5890) with standard treatment (pembrolizumab and chemotherapy) before surgery can help treat triple negative breast cancer (TNBC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Triple Negative Breast Cancer
- What is being tested?
- Pembrolizumab, Paclitaxel and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Mar 2025to 18 Mar 2031
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Optum Care Cancer Center ( Site 0004)
Las Vegas, Nevada, 89102
About this study
Official title: A Phase 2, Umbrella Study to Evaluate the Safety, Tolerability, and Clinical Activity of Investigational Agents for Newly Diagnosed, High-Risk, Early-Stage Triple-Negative Breast Cancer
Researchers want to learn if giving boserolimab (MK-5890) with standard treatment (pembrolizumab and chemotherapy) before surgery can help treat triple negative breast cancer (TNBC). The goals of this study are to learn about the safety of boserolimab given with standard treatment before surgery and to learn if people tolerate it and how many people have no signs of cancer in the tissues and lymph nodes removed during surgery.
Read the detailed description
The umbrella design of this study provides the framework to evaluate the safety, tolerability and clinical activity of different investigational agents in participants with newly diagnosed, high-risk, early-stage TNBC who might benefit from adding these investigational agents to pembrolizumab plus chemotherapy.
- Conditions
- Early Triple Negative Breast Cancer
- Being tested
- Pembrolizumab, Paclitaxel, Carboplatin, Doxorubicin (hydrochloride), Boserolimab
- Keywords
- Triple Negative Breast Cancer, Breast cancer, Neoadjuvant, Boserolimab, Pembrolizumab, Umbrella study
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabBiological
Also called MK-3475, Keytruda®, SCH 900475
Neoadjuvant therapy - 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to approximately 24 weeks Adjuvant therapy - 200 mg IV infusion Q3W or 400 mg IV infusion every 6 weeks (Q6W) for up to approximately 30 weeks.
PaclitaxelDrug
80 mg/m^2 by IV infusion every week for up to 12 weeks.
CarboplatinDrug
AUC 1.5 mg/mL/min by IV infusion every week for up to 12 weeks.
Doxorubicin (hydrochloride)Drug
60 mg/m^2 by IV infusion Q3W for up to 12 weeks.
BoserolimabBiological
Also called MK-5890
30 mg by IV infusion every 6 weeks (Q6W) for up to 12 Weeks.
Epirubicin HydrochlorideDrug
90 mg/m^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks.
CyclophosphamideDrug
600 mg/m^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks.
CapecitabineDrug
1000 mg/m^2 to 1250 mg/m^2 by oral administration twice a day (2 weeks on and 1 week off) for up to approximately 24 weeks.
Olaparib (if approved/available locally)Drug
300 mg by oral administration twice a day for up to approximately 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab+ Paclitaxel+ Carboplatin | Active comparator | Participants will receive pembrolizumab PLUS paclitaxel PLUS carboplatin followed by pembrolizumab PLUS doxorubicin hydrochloride or epirubicin hydrochloride and cyclophosphamide as neoadjuvant therapy prior to surgery. In adjuvant therapy participants will receive pembrolizumab PLUS optional additional adjuvant treatment of physician's choice (TPC), capecitabine or olaparib. Receives: Biological: Pembrolizumab; Drug: Paclitaxel; Drug: Carboplatin; Drug: Doxorubicin (hydrochloride); Drug: Epirubicin Hydrochloride; Drug: Cyclophosphamide; Drug: Capecitabine; Drug: Olaparib (if approved/available locally) |
| Pembrolizumab+Boserolimab+Paclitaxel+ Carboplatin | Experimental | Participants will receive pembrolizumab PLUS boserolimab PLUS paclitaxel PLUS carboplatin followed by pembrolizumab PLUS doxorubicin hydrochloride or epirubicin hydrochloride and cyclophosphamide PLUS boserolimab as neoadjuvant therapy prior to surgery. In adjuvant therapy participants will receive pembrolizumab PLUS optional additional adjuvant treatment of physician's choice (TPC), capecitabine or olaparib. Receives: Biological: Pembrolizumab; Drug: Paclitaxel; Drug: Carboplatin; Drug: Doxorubicin (hydrochloride); Biological: Boserolimab; Drug: Epirubicin Hydrochloride; Drug: Cyclophosphamide; Drug: Capecitabine; Drug: Olaparib (if approved/available locally) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with one or more adverse events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Measured: Up to approximately 34 months
Number of participants who discontinue study intervention due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Measured: Up to approximately 27 months
Pathological complete response (pCR) rate at the time of definitive surgery
pCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy per current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.
Measured: Up to approximately 9 months
Secondary outcomes (3)
pCR-no ductal carcinoma in situ (DCIS) rate at the time of definitive surgery
pCR-no ductal carcinoma in situ (DCIS) (ypT0 ypN0) is defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy per current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery.
Measured: Up to approximately 9 months
Event-Free Survival (EFS)
EFS is defined as the time from randomization to disease progression that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.
Measured: Up to approximately 72 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start26 Mar 2025 (estimated)
- Primary completion18 Jan 2029 (estimated)
- Study completion18 Mar 2031 (estimated)
Why it stopped: Since patients were not recruited yet, we would mark this as a Withdrawn status per the NIH definition of that status. Study halted prematurely, prior to enrollment of first participant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829199
- Sponsor's protocol ID
- 5890-003
- Other IDs
- MK-5890-003, 2024-517505-87-00, U1111-1312-3982
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Umbrella Study to Evaluate the Safety, Tolerability, and Clinical Activity of Investigational Agents for Newly Diagnosed, High-Risk, Early-Stage Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06829199
- Acronym / sponsor ID
- 5890-003
- Conditions
- Early Triple Negative Breast Cancer
- Keywords
- Triple Negative Breast Cancer, Breast cancer, Neoadjuvant, Boserolimab, Pembrolizumab, Umbrella study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Since patients were not recruited yet, we would mark this as a Withdrawn status per the NIH definition of that status. Study halted prematurely, prior to enrollment of first participant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2025 (estimated)
- Primary completion
- 18 Jan 2029 (estimated)
- Study completion
- 18 Mar 2031 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers want to learn if giving boserolimab (MK-5890) with standard treatment (pembrolizumab and chemotherapy) before surgery can help treat triple negative breast cancer (TNBC). The goals of this study are to learn about the safety of boserolimab given with standard treatment before surgery and to learn if people tolerate it and how many people have no signs of cancer in the tissues and lymph nodes removed during surgery.
Detailed description
The umbrella design of this study provides the framework to evaluate the safety, tolerability and clinical activity of different investigational agents in participants with newly diagnosed, high-risk, early-stage TNBC who might benefit from adding these investigational agents to pembrolizumab plus chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab+ Paclitaxel+ Carboplatin | Active comparator | Biological: Pembrolizumab, Drug: Paclitaxel, Drug: Carboplatin, Drug: Doxorubicin (hydrochloride), Drug: Epirubicin Hydrochloride, Drug: Cyclophosphamide, Drug: Capecitabine, Drug: Olaparib (if approved/available locally)Participants will receive pembrolizumab PLUS paclitaxel PLUS carboplatin followed by pembrolizumab PLUS doxorubicin hydrochloride or epirubicin hydrochloride and cyclophosphamide as neoadjuvant therapy prior to surgery. In adjuvant therapy participants will receive pembrolizumab PLUS optional additional adjuvant treatment of physician's choice (TPC), capecitabine or olaparib. |
| Pembrolizumab+Boserolimab+Paclitaxel+ Carboplatin | Experimental | Biological: Pembrolizumab, Drug: Paclitaxel, Drug: Carboplatin, Drug: Doxorubicin (hydrochloride), Biological: Boserolimab, Drug: Epirubicin Hydrochloride, Drug: Cyclophosphamide, Drug: Capecitabine, Drug: Olaparib (if approved/available locally)Participants will receive pembrolizumab PLUS boserolimab PLUS paclitaxel PLUS carboplatin followed by pembrolizumab PLUS doxorubicin hydrochloride or epirubicin hydrochloride and cyclophosphamide PLUS boserolimab as neoadjuvant therapy prior to surgery. In adjuvant therapy participants will receive pembrolizumab PLUS optional additional adjuvant treatment of physician's choice (TPC), capecitabine or olaparib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: MK-3475, Keytruda®, SCH 900475Neoadjuvant therapy - 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to approximately 24 weeks Adjuvant therapy - 200 mg IV infusion Q3W or 400 mg IV infusion every 6 weeks (Q6W) for up to approximately 30 weeks. | Biological | Pembrolizumab+ Paclitaxel+ Carboplatin, Pembrolizumab+Boserolimab+Paclitaxel+ Carboplatin |
| Paclitaxel80 mg/m^2 by IV infusion every week for up to 12 weeks. | Drug | Pembrolizumab+ Paclitaxel+ Carboplatin, Pembrolizumab+Boserolimab+Paclitaxel+ Carboplatin |
| CarboplatinAUC 1.5 mg/mL/min by IV infusion every week for up to 12 weeks. | Drug | Pembrolizumab+ Paclitaxel+ Carboplatin, Pembrolizumab+Boserolimab+Paclitaxel+ Carboplatin |
| Doxorubicin (hydrochloride)60 mg/m^2 by IV infusion Q3W for up to 12 weeks. | Drug | Pembrolizumab+ Paclitaxel+ Carboplatin, Pembrolizumab+Boserolimab+Paclitaxel+ Carboplatin |
| BoserolimabAlso: MK-589030 mg by IV infusion every 6 weeks (Q6W) for up to 12 Weeks. | Biological | Pembrolizumab+Boserolimab+Paclitaxel+ Carboplatin |
| Epirubicin Hydrochloride90 mg/m^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks. | Drug | Pembrolizumab+ Paclitaxel+ Carboplatin, Pembrolizumab+Boserolimab+Paclitaxel+ Carboplatin |
| Cyclophosphamide600 mg/m^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks. | Drug | Pembrolizumab+ Paclitaxel+ Carboplatin, Pembrolizumab+Boserolimab+Paclitaxel+ Carboplatin |
| Capecitabine1000 mg/m^2 to 1250 mg/m^2 by oral administration twice a day (2 weeks on and 1 week off) for up to approximately 24 weeks. | Drug | Pembrolizumab+ Paclitaxel+ Carboplatin, Pembrolizumab+Boserolimab+Paclitaxel+ Carboplatin |
| Olaparib (if approved/available locally)300 mg by oral administration twice a day for up to approximately 52 weeks. | Drug | Pembrolizumab+ Paclitaxel+ Carboplatin, Pembrolizumab+Boserolimab+Paclitaxel+ Carboplatin |
Primary outcome
Number of participants with one or more adverse events (AEs)
Time frame: Up to approximately 34 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Number of participants who discontinue study intervention due to an AE
Time frame: Up to approximately 27 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Pathological complete response (pCR) rate at the time of definitive surgery
Time frame: Up to approximately 9 months
pCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy per current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.
3 secondary outcomes
pCR-no ductal carcinoma in situ (DCIS) rate at the time of definitive surgery
Time frame: Up to approximately 9 months
Event-Free Survival (EFS)
Time frame: Up to approximately 72 months
Overall Survival (OS)
Time frame: Up to approximately 72 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Plain Language SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Paclitaxel and Carboplatin in people with Early Triple Negative Breast Cancer, run by Merck Sharp & Dohme LLC at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with one or more adverse events (AEs) (time frame: Up to approximately 34 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.