Metastatic Breast CancerPhase 3KATE3NCT04740918
A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)
A Phase 3 study testing Trastuzumab Emtansine and Atezolizumab in people with Metastatic Breast Cancer, run by Hoffmann-La Roche at 51 sites in 19 countries.
Trial summary
This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Trastuzumab Emtansine and Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 51 sitesin 19 countries
- Study dates
- 7 Jun 2021to 19 Jun 2024
- Phase
- Phase 3
- 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
- HER2+ and PD-L1+ locally advanced (LABC) or metastatic breast cancer (MBC)
- Progression must have occurred during most recent treatment for LABC/MBC or during, or within 6 months after completing, neoadjuvant and/or adjuvant therapy
- Prior treatment with trastuzumab (+/- pertuzumab) and taxane in the neoadjuvant and/or adjuvant, locally advanced, or metastatic setting
- No more than two prior lines of therapy in the metastatic setting
- Measurable disease per RESIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
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- Life expectancy >= 6 months
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs
- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
Who cannot join
- Prior treatment with trastuzumab emtansine in metastatic setting
- History of exposure to cumulative doses of anthracyclines
- Symptomatic or actively progressing central nervous system (CNS) metastases; asymptomatic CNS lesions ≤ 2cm without clinical requirement for local intervention or asymptomatic patients with treated CNS lesions are eligible
- Current Grade >= 3 peripheral neuropathy
- Cardiopulmonary dysfunction
- History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation and malignancies with a negligible risk of metastasis or death
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- History of leptomeningeal disease
- Active or history of autoimmune disease or immune deficiency
- Active hepatitis B, hepatitis C and/or tuberculosis
- Prior allogeneic stem cell or solid organ transplantation
- Receipt of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, during treatment, or within 5 months following the last dose of study treatment
- Pregnancy or lactation
Trial locations and contacts
51 sites in 19 countries.
51 sites in 19 countries
China10 sites
Peking University People's Hospital
Beijing, 100044
Beijing Cancer Hospital
Beijing, 100142
The First Hospital of Jilin University
Changchun, 130021
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, 510120
Zhejiang Provincial People's Hospital
Hangzhou, 310014
Harbin Medical University Cancer Hospital
Harbin, 150081
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, 210029
Tianjin Medical University Cancer Institute & Hospital
Tianjing, 300060
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430023
Henan Cancer Hospital
Zhengzhou, 450008
Turkey (Türkiye)7 sites
Adana Baskent University Medical Faculty
Adana, 01220
Sakarya Universitesi Egitim ve Arastirma Hastanesi
Adapazari/Sakarya, 54100
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul, 34147
Acibadem University School of Medicine Altunizade Hospital Oncology Service
Istanbul, 34742
Katip Celebi University Ataturk Training and Research Hospital
Izmir, 35360
Kayseri Acibadem Hospital
Kayseri, 38000
Hacettepe Uni Medical Faculty Hospital
Sihhiye/Ankara, 06230
Brazil5 sites
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, 98700-000
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, 50040-000
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, 41253-190
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
Núcleo de Pesquisa São Camilo
São Paulo, São Paulo, 03102-002
Italy3 sites
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
Avellino, Campania, 83100
Azienda Ospedaliera S. Orsola-Malpighi
Bologna, Emilia-Romagna, 40138
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
Naples, Campania, 80131
Philippines3 sites
Cebu Doctors' University Hospital
Cebu City, 6000
St. Luke's Medical Center
Quezon City, 1102
Cardinal Santos Medical Center
San Juan City, 1502
United Kingdom3 sites
UCL Hospital NHS Trust
London, NW1 2PG
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, SE1 9RT
Nottingham University Hospitals City Campus
Nottingham, NG5 1PB
Canada2 sites
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2
Centre Hospitalier de l?Université de Montréal (CHUM)
Montreal, Quebec, H2X 0C2
Colombia2 sites
Clinica Vida
Medellín, DUMMY_VALUE
Oncomedica S.A.
Montería, 230002
Croatia2 sites
Clinical Hospital Center Sestre Milosrdnice
Zagreb, 10000
Clinical Hospital Centre Zagreb
Zagreb, 10000
Finland2 sites
Helsinki University Central Hospital
Helsinki, 00029
Tampere University Hospital
Tampere, 33520
Poland2 sites
Opolskie Centrum Onkologii
Opole, 45-061
Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
Warsaw, 02-781
Portugal2 sites
Centro Hospitalar do Porto ? Hospital de Santo António
Porto, 4099-001
IPO do Porto
Porto, 4200-072
Spain2 sites
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Quiron Madrid
Pozuelo de Alarcón, Madrid, 28223
Russia1 site
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
Ufa, Bashkortostan Republic, 450054
About this study
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- (+/- Pertuzumab) and Taxane-Based Therapy (KATE3)
This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Trastuzumab Emtansine, Atezolizumab, Placebo
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab EmtansineDrug
Also called Kadcyla, T-DM1, RO5304020
Trastuzumab emtansine 3.6 mg/kg IV infusion
AtezolizumabDrug
Also called Tecentriq, RO5541267, MPDL3280A
Atezolizumab 1200 mg IV infusion
PlaceboOther
Placebo matched to atezolizumab
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Trastuzumab Emtansine and Placebo | Active comparator | Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor. Receives: Drug: Trastuzumab Emtansine; Other: Placebo |
| Arm B: Trastuzumab Emtansine and Atezolizumab | Experimental | Atezolizumab 1200 mg IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor. Receives: Drug: Trastuzumab Emtansine; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
PFS was defined as the time from randomization to the first occurrence of documented disease progression (PD), as determined by the investigator according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Median PFS was calculated using the Kaplan-Meier (KM) methodology. Data for participants without PD or death from any cause as of the data cut-off date were censored at the time of the last tumor assessment.
Measured: Up to 28 months
Overall Survival (OS)
OS was defined as the time from the first dose of study treatment to the time of death from any cause. Participants who are alive as of the data cut-off date of the analysis were censored at the last known date they were alive. Participants with no post-baseline information were censored at the date of randomization plus 1 day. Median OS was calculated using the KM methodology.
Measured: Up to 28 months
Secondary outcomes (7)
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) on two consecutive assessments, at least 28 days apart, as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. Only participants with measurable disease at baseline were analyzed for this outcome measure. Participants without a post-baseline tumor assessment were considered non-responders. An estimate of the ORR and its 95% CI (Wilson score confidence interval) were calculated for each treatment arm.
Measured: Up to 28 months
Duration of Response (DOR)
DOR was calculated for participants who had a best OR of CR/PR. DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurs first as determined by investigator assessment using RECIST v1.1. CR=the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR=at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Median DOR was calculated using the KM methodology.
Measured: Up to 28 months
PFS in Participants With Baseline Brain Metastases as Determined by Investigator Assessment Using RECIST v1.1
PFS was defined as the time from randomization to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Median PFS was calculated using the KM methodology.
Measured: Up to 28 months
OS in Participants With Baseline Brain Metastases
OS is defined as the time from the first dose of study treatment to the time of death from any cause. Median OS was calculated using the KM methodology.
Measured: Up to 28 months
Central Nervous System (CNS) PFS as Determined by Investigator Using RECIST v1.1 in Participants With Baseline CNS Metastases
CNS PFS was defined as the time from randomization to the first occurrence of documented CNS PD, or first occurrence of symptomatic CNS disease as determined by the investigator according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Median PFS was calculated using the KM methodology. Participants who experienced non-CNS PD at the time of analysis were censored at the date of this progression. Participants who experienced no PD and were alive at the time of analysis were censored at date of their last post-baseline tumor assessment or, if they had no post-baseline tumor assessment, on the date of randomization + 1 day.
Measured: Up to 28 months
CNS PFS as Determined by Investigator Using RECIST v1.1 in Participants Without Baseline CNS Metastases
CNS PFS was defined as the time from randomization to the first occurrence of documented CNS PD, or first occurrence of symptomatic CNS disease as determined by the investigator according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Median PFS was calculated using the KM methodology. Participants who experienced non-CNS PD at the time of analysis were censored at the date of this progression. Participants who experienced no PD and were alive at the time of analysis were censored at date of their last post-baseline tumor assessment or, if they had no post-baseline tumor assessment, on the date of randomization + 1 day.
Measured: Up to 28 months
Percentage of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Measured: Up to 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start7 Jun 2021
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Why it stopped: Due to low enrollment, the Sponsor decided to prematurely terminate the study
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.
- More trials run by Hoffmann-La RocheThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740918
- Sponsor's protocol ID
- MO42319
- Other IDs
- 2020-002818-41
- Acronym
- KATE3
- Status last verified
- Jul 2025
- First submitted
- 3 Feb 2021
- Last updated
- 8 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- (+/- Pertuzumab) and Taxane-Based Therapy (KATE3)
- ClinicalTrials.gov ID
- NCT04740918
- Acronym / sponsor ID
- KATE3 / MO42319
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low enrollment, the Sponsor decided to prematurely terminate the study
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Posted 8 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Trastuzumab Emtansine and Placebo | Active comparator | Drug: Trastuzumab Emtansine, Other: PlaceboPlacebo matched to atezolizumab followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor. |
| Arm B: Trastuzumab Emtansine and Atezolizumab | Experimental | Drug: Trastuzumab Emtansine, Drug: AtezolizumabAtezolizumab 1200 mg IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- HER2+ and PD-L1+ locally advanced (LABC) or metastatic breast cancer (MBC)
- Progression must have occurred during most recent treatment for LABC/MBC or during, or within 6 months after completing, neoadjuvant and/or adjuvant therapy
- Prior treatment with trastuzumab (+/- pertuzumab) and taxane in the neoadjuvant and/or adjuvant, locally advanced, or metastatic setting
- No more than two prior lines of therapy in the metastatic setting
- Measurable disease per RESIST version 1.1
Key exclusion criteria (12 listed)
- Prior treatment with trastuzumab emtansine in metastatic setting
- History of exposure to cumulative doses of anthracyclines
- Symptomatic or actively progressing central nervous system (CNS) metastases; asymptomatic CNS lesions ≤ 2cm without clinical requirement for local intervention or asymptomatic patients with treated CNS lesions are eligible
- Current Grade >= 3 peripheral neuropathy
- Cardiopulmonary dysfunction
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 |
|---|---|---|
| Trastuzumab EmtansineAlso: Kadcyla, T-DM1, RO5304020Trastuzumab emtansine 3.6 mg/kg IV infusion | Drug | Arm A: Trastuzumab Emtansine and Placebo, Arm B: Trastuzumab Emtansine and Atezolizumab |
| AtezolizumabAlso: Tecentriq, RO5541267, MPDL3280AAtezolizumab 1200 mg IV infusion | Drug | Arm B: Trastuzumab Emtansine and Atezolizumab |
| PlaceboPlacebo matched to atezolizumab | Other | Arm A: Trastuzumab Emtansine and Placebo |
Primary outcome
Progression-Free Survival (PFS) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Up to 28 months
PFS was defined as the time from randomization to the first occurrence of documented disease progression (PD), as determined by the investigator according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Median PFS was calculated using the Kaplan-Meier (KM) methodology. Data for participants without PD or death from any cause as of the data cut-off date were censored at the time of the last tumor assessment.
Overall Survival (OS)
Time frame: Up to 28 months
OS was defined as the time from the first dose of study treatment to the time of death from any cause. Participants who are alive as of the data cut-off date of the analysis were censored at the last known date they were alive. Participants with no post-baseline information were censored at the date of randomization plus 1 day. Median OS was calculated using the KM methodology.
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 28 months
Duration of Response (DOR)
Time frame: Up to 28 months
PFS in Participants With Baseline Brain Metastases as Determined by Investigator Assessment Using RECIST v1.1
Time frame: Up to 28 months
OS in Participants With Baseline Brain Metastases
Time frame: Up to 28 months
Central Nervous System (CNS) PFS as Determined by Investigator Using RECIST v1.1 in Participants With Baseline CNS Metastases
Time frame: Up to 28 months
CNS PFS as Determined by Investigator Using RECIST v1.1 in Participants Without Baseline CNS Metastases
Time frame: Up to 28 months
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to 28 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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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.
Clinical Trials study director
Hoffmann-La Roche
51 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trastuzumab Emtansine and Atezolizumab in people with Metastatic Breast Cancer, run by Hoffmann-La Roche at 51 sites in 19 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 10 inclusion and 12 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: stopped early, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in China, Turkey (Türkiye), Brazil, Italy, Philippines and 14 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 8 Aug 2025). 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?
Progression-Free Survival (PFS) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (time frame: Up to 28 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 8 Aug 2025.