Metastatic Breast CancerPhase 2NCT04699630
A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer
A Phase 2 study testing U3-1402 in people with Metastatic Breast Cancer and Locally Advanced Breast Cancer, run by SCRI Development Innovations, LLC at 11 sites in United States.
Trial summary
This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 (patritumab deruxtecan) in patients with locally advanced or metastatic breast cancer (MBC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Locally Advanced Breast Cancer
- What is being tested?
- U3-1402
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 11 sitesUnited States
- Study dates
- 3 May 2021to 9 Apr 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
None listed.
Who cannot join
- Patients who meet any of the following criteria will be excluded from study entry:
- Exclusion criteria for Parts A and B (HER2-negative) and Part Z (HER2-positive) cohorts:
- Treatment with any of the following:
- Any systemic anti-cancer chemotherapy, small molecule, biologic, hormonal agent, or immune checkpoint inhibitor therapy from a previous treatment regimen or clinical study within 21 days prior to the first dose of patritumab deruxtecan
- Prior treatment with any HER3-targeting agent
- Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug treatment
Show all 42Show fewer
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug treatment, or palliative radiation therapy within 2 weeks of the first dose of study drug treatment
- Chloroquine /hydroxychloroquine ≤14 days prior to the first dose of study drug treatment
- Has any hypersensitivity to drug substances or inactive ingredients in drug product
- Has any history of ILD (including pulmonary fibrosis or radiation pneumonitis), has clinically significant ILD, or is suspected to have such disease by imaging during screening. If imaging findings are unlikely to indicate a history of pneumonitis, then the Investigator should discuss the considerations with the Medical Monitor about potential enrollment and record the reasoning in the source documentation.
- Clinically severe pulmonary compromise (based on Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:
- Any underlying pulmonary disorder (e.g., pulmonary emboli, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion)
- Any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis)
- OR prior pneumonectomy
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline at the time of starting study treatment. Note: patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible with approval by the Medical Monitor.
- Leptomeningeal metastases or evidence of spinal cord compression or brain metastases, defined as being clinically active and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Patients with clinically inactive or treated brain metastases who are asymptomatic (i.e., without neurologic signs or symptoms and do not require treatment with corticosteroids or anticonvulsants) may be included in the study. Patients must have a stable neurologic status for at least 2 weeks prior to Cycle 1 Day 1.
- Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 7 months after the last administration of study treatment
- Men who plan to father a child while in the study and for at least 7 months after the last administration of study treatment
- Uncontrolled or significant cardiovascular disorder prior to Cycle 1 Day 1, including:
- Mean resting corrected QT interval using Fridericia's formula (QTcF) prolongation to >470 ms for females and >450 ms for males in three successive screening measurements
- Patients with a left ventricular ejection fraction (LVEF) <50%
- Resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg).
- Documented myocardial infarction within 6 months
- Congestive heart failure (New York Heart Association ≥ Grade 2 within 28 days
- Has known clinically significant corneal disease from prior therapies such as drug-induced keratitis
- Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1. Patients who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.
- As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection, including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.
- Presence of other active invasive cancers other than the one treated in this study within 3 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol
- Additional exclusion criteria only for Parts A and B (HER2-negative) cohorts:
- Patients with HER2+ breast cancer per ASCO-CAP guidelines
- Part A only: Prior treatment with an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan, DS-1062a [datopotamab deruxtecan], and DS-7300a [B7-H3 DXd-ADC])
- Part B patients only: Prior treatment with trastuzumab deruxtecan, sacituzumab govitecan, and/or datopotamab deruxtecan with any of the following:
- A severe reaction or severe tolerability issues that necessitated stopping treatment with the therapy
- Any unresolved toxicities from the prior therapy greater than Grade 1, with the exception of alopecia
- Additional exclusion criteria only for Part Z (HER2-positive) cohort:
- Treatment with any of the following:
- Prior treatment with an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor except trastuzumab deruxtecan
- Prior treatment with trastuzumab deruxtecan within 4 weeks prior to the first dose of patritumab deruxtecan
- Uncontrolled or significant cardiovascular disease, including history of myocardial infarction within 6 months before enrollment
- A severe reaction or severe tolerability issues that necessitated stopping treatment with trastuzumab deruxtecan
- Any unresolved toxicities from prior therapy with trastuzumab deruxtecan
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Levine Cancer Institute
Charlotte, North Carolina, 28204
City of Hope
Duarte, California, 91010
Florida Cancer Specialists-South
Fort Myers, Florida, 33901
SCRI Oncology Partners
Nashville, Tennessee, 37203
Tennessee Oncology
Nashville, Tennessee, 37203
Rutgers-Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Highlands Oncology Group
Springdale, Arkansas, 72762
Washington University School of Medicine
St Louis, Missouri, 63110
Florida Cancer Specialists-North
St. Petersburg, Florida, 33705
About this study
Official title: A Phase II Study of U3-1402 (Patritumab Deruxtecan) in Patients With Metastatic Breast Cancer
This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 (patritumab deruxtecan) in patients with locally advanced or metastatic breast cancer (MBC).
Read the detailed description
U3-1402 (Patritumab Deruxtecan) is an antibody drug conjugate comprising a recombinant fully human anti HER3 monoclonal antibody linked to a linker containing topoisomerase I inhibitor. This is a phase II study of U3-1402 (patritumab deruxtecan) in subjects with MBC. The study will be conducted in 3 parts (Part A , Part B, and Part Z). All enrolled subjects in Part A will undergo pretreatment biopsies to determine if subjects with particular biomarker expression (ER/PR/HER2/HER3) show preliminary efficacy. Part B will enroll subgroups of participants that are metastatic, hormone receptor-positive (HR+) HER2-negative or triple-negative (mTNBC) regardless of HER3 expression that were defined from Part A analysis. Part Z will enroll participants with HER2- positive (HER2+) MBC.
- Being tested
- U3-1402
- Keywords
- Breast Neoplasm, HER3 Expression, Hormone Receptor Positive Breast Cancer, Triple Negative Breast Cancer, Metastatic breast cancer, locally advanced breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U3-1402Drug
Also called Patritumab Deruxtecan
All subjects will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 of every 3 weeks. One cycle is defined as 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies. (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). Up to 60 HER2-negative participants will be enrolled into this arm. Receives: Drug: U3-1402 |
| Part B | Experimental | Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B will enroll 20 participants with metastatic hormone-receptor positive (HR+) HER2-negative cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression. Receives: Drug: U3-1402 |
| Part Z | Experimental | Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z will enroll an additional 21 participants with HER2+ MBC. Receives: Drug: U3-1402 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) in Participants With HER2-negative MBC (Part A and Part B)
Overall Response Rate (ORR) is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) out of all treated participants. Confirmed response is two consecutive CR or PR at least 4 weeks apart according to RECIST v1.1 criteria. CR=disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of lesion diameters.
Measured: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.
Progression-Free Survival at 6 Months (PFS-6) in Participants With HER2-negative MBC (Part A and Part B)
Progression-Free Survival at 6 months (PFS-6) is defined as the rate of patients who survive progression-free for at least 6 months per RECIST version (v) 1.1. Per RECIST V1.1, progressive disease is defined as a ≥20% increase in target lesions and ≥5mm increase in size from smallest sum, appearance of any new lesions, or unequivocal progression of non-target lesions.
Measured: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.
Secondary outcomes (6)
Incidence of Treatment- Emergent Adverse Events to Assess Safety and Tolerability
The safety and tolerability of U3-1402 (Patritumab Deruxtecan) was assessed through the analysis of the reported incidence of treatment-emergent AEs. Treatment-emergent AEs are those with an onset on or after the initiation of study therapy up to 40 days after last day of treatment, and will be graded according to NCI CTCAE 5.0.
Measured: Every 3 weeks, up to 45 months.
Duration of Response (DOR)
Duration of response (DOR) is calculated only for participants who experienced a Complete Response (CR) or Partial Response (PR) per RECIST V1.1 and is defined as the median number of months of duration from the first documented response [complete response (CR) or partial response (PR)] to the date of disease progression (PD) according to the RECIST V1.1 criteria or death due to any cause. Per RECIST V1.1, CR=disappearance of all target lesions, PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of target lesion diameters, PD is ≥20% increase in target lesions and ≥5mm from smallest sum, appearance of any new lesions, or unequivocal progression of non-target lesions. Kaplan-Meier estimates were used to calculate the 95% confidence intervals for duration of response.
Measured: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.
Progression-Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time from start of study treatment to the date of the first documented disease progression (PD) according to the RECIST V1.1 criteria or death due to any cause. Per RECIST V1.1, PD is ≥20% increase in target lesions and ≥5mm increase from smallest sum, appearance of any new lesions, or unequivocal progression of non-target lesions.
Measured: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.
Clinical Benefit Rate (CBR)
CBR is defined as the rate of participants with complete response (CR), partial response (PR), or best overall response of stable disease (SD) for ≥ 6 months according to the RECIST v 1.1 criteria. Per RECIST V1.1: A CR is defined as the disappearance of all target and non-target lesions. A PR is defined as ≥30% decrease in the sum of diameters of target lesions from the baseline sum. A SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
Measured: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.
Overall Response Rate (ORR) in Participants With HER2-positive (HER2+) MBC After Progression on Trastuzumab Deruxtecan: Part Z
Overall Response Rate (ORR) is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) out of all treated participants. Confirmed response is two consecutive CR or PR at least 4 weeks apart according to RECIST v1.1 criteria. CR=disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of lesion diameters.
Measured: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.
Progression-Free Survival at 6 Months (PFS-6) in Participants With HER2-positive (HER2+) MBC: Part Z
Progression-Free Survival at 6 months (PFS-6) is defined as the rate of patients who survive progression-free for at least 6 months per RECIST version (v) 1.1. Per RECIST V1.1, progressive disease is defined as a ≥20% increase in target lesions and ≥5mm increase in size from smallest sum, appearance of any new lesions, or unequivocal progression of non-target lesions.
Measured: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start3 May 2021
- Primary completion9 Apr 2025
- Study completion9 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
- Investigators
- Erika Hamilton, MD, Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699630
- Sponsor's protocol ID
- BRE 354
- Status last verified
- May 2026
- First submitted
- 5 Jan 2021
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of U3-1402 (Patritumab Deruxtecan) in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04699630
- Acronym / sponsor ID
- BRE 354
- Keywords
- Breast Neoplasm, HER3 Expression, Hormone Receptor Positive Breast Cancer, Triple Negative Breast Cancer, Metastatic breast cancer, locally advanced breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Daiichi Sankyo
- Study start
- 3 May 2021 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Posted 7 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 (patritumab deruxtecan) in patients with locally advanced or metastatic breast cancer (MBC).
Detailed description
U3-1402 (Patritumab Deruxtecan) is an antibody drug conjugate comprising a recombinant fully human anti HER3 monoclonal antibody linked to a linker containing topoisomerase I inhibitor. This is a phase II study of U3-1402 (patritumab deruxtecan) in subjects with MBC. The study will be conducted in 3 parts (Part A , Part B, and Part Z). All enrolled subjects in Part A will undergo pretreatment biopsies to determine if subjects with particular biomarker expression (ER/PR/HER2/HER3) show preliminary efficacy. Part B will enroll subgroups of participants that are metastatic, hormone receptor-positive (HR+) HER2-negative or triple-negative (mTNBC) regardless of HER3 expression that were defined from Part A analysis. Part Z will enroll participants with HER2- positive (HER2+) MBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: U3-1402Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies. (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). Up to 60 HER2-negative participants will be enrolled into this arm. |
| Part B | Experimental | Drug: U3-1402Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B will enroll 20 participants with metastatic hormone-receptor positive (HR+) HER2-negative cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression. |
| Part Z | Experimental | Drug: U3-1402Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z will enroll an additional 21 participants with HER2+ MBC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (42 listed)
- Treatment with any of the following:
- Has any hypersensitivity to drug substances or inactive ingredients in drug product
- Has any history of ILD (including pulmonary fibrosis or radiation pneumonitis), has clinically significant ILD, or is suspected to have such disease by imaging during screening. If imaging findings are unlikely to indicate a history of pneumonitis, then the Investigator should discuss the considerations with the Medical Monitor about potential enrollment and record the reasoning in the source documentation.
- Clinically severe pulmonary compromise (based on Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:
- OR prior pneumonectomy
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 |
|---|---|---|
| U3-1402Also: Patritumab DeruxtecanAll subjects will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 of every 3 weeks. One cycle is defined as 3 weeks. | Drug | Part A, Part B, Part Z |
Primary outcome
Overall Response Rate (ORR) in Participants With HER2-negative MBC (Part A and Part B)
Time frame: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.
Overall Response Rate (ORR) is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) out of all treated participants. Confirmed response is two consecutive CR or PR at least 4 weeks apart according to RECIST v1.1 criteria. CR=disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of lesion diameters.
Progression-Free Survival at 6 Months (PFS-6) in Participants With HER2-negative MBC (Part A and Part B)
Time frame: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.
Progression-Free Survival at 6 months (PFS-6) is defined as the rate of patients who survive progression-free for at least 6 months per RECIST version (v) 1.1. Per RECIST V1.1, progressive disease is defined as a ≥20% increase in target lesions and ≥5mm increase in size from smallest sum, appearance of any new lesions, or unequivocal progression of non-target lesions.
6 secondary outcomes
Incidence of Treatment- Emergent Adverse Events to Assess Safety and Tolerability
Time frame: Every 3 weeks, up to 45 months.
Duration of Response (DOR)
Time frame: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.
Progression-Free Survival (PFS)
Time frame: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.
Clinical Benefit Rate (CBR)
Time frame: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.
Overall Response Rate (ORR) in Participants With HER2-positive (HER2+) MBC After Progression on Trastuzumab Deruxtecan: Part Z
Time frame: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.
Progression-Free Survival at 6 Months (PFS-6) in Participants With HER2-positive (HER2+) MBC: Part Z
Time frame: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Erika Hamilton, MD study chair
SCRI Development Innovations, LLC
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing U3-1402 in people with Metastatic Breast Cancer and Locally Advanced Breast Cancer, run by SCRI Development Innovations, LLC at 11 sites in United States.
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 0 inclusion and 42 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: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
Yes. Results are posted in the registry (first posted 7 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (ORR) in Participants With HER2-negative MBC (Part A and Part B) (time frame: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.). The study lists 2 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 22 May 2026.