Advanced or Metastatic Breast CancerPhase 2NCT06105632
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment
A Phase 2 study testing PF-07220060 CDK4 inhibitor, Fulvestrant and Everolimus in people with Advanced or Metastatic Breast Cancer, run by Pfizer at 48 sites in 14 countries.
Trial summary
The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Breast Cancer
- What is being tested?
- PF-07220060 CDK4 inhibitor, Fulvestrant and Everolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 48 sitesin 14 countries
- Study dates
- 9 Jan 2024to 21 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
- Documented estrogen receptor (ER) and/or progesterone receptor (PR)- positive tumor
- Documented HER2-negative tumor
- Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.
- Must have received CDK4/6i plus NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment.
- Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.
Who cannot join
- Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
- In visceral crisis at risk of immediately life-threatening complications in the short term.
- Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
- Prior treatment with any of the following:
- Everolimus or investigational anti-cancer agents in any setting
- Prior chemotherapy in the advanced setting
Show all 9Show fewer
- Radiation within 2 weeks of randomization
- Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, other endocrine therapies, growth factors, chronic systemic corticosteroids, strong cytochrome P450 3A4/5 [CYP3A4/5] or uridine 5' diphosphate-glucuronosyltransferase 2B7 [UGT2B7] inhibitors and inducers, direct oral anticoagulants, proton pump inhibitors).
- Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.
Trial locations and contacts
48 sites in 14 countries.
48 sites in 14 countries
United States9 sites
Intermountain Health St. Vincent Regional Hospital
Billings, Montana, 59101
Memorial Hermann Cancer Center
Houston, Texas, 77030
Hoag Health Center Irvine
Irvine, California, 92618
Hoag Hospital Irvine
Irvine, California, 92618
Keck Hospital of USC
Los Angeles, California, 90033
Los Angeles General Medical Center
Los Angeles, California, 90033
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Japan7 sites
Chiba cancer center
Chiba, 260-8717
St. Luke's International Hospital
Chuo-ku, Tokyo, 104-8560
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518
National Hospital Organization Osaka National Hospital
Osaka, 540-0006
Gunma Prefectural Cancer Center
Otashi, Gunma, 373-8550
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Osaka University Hospital
Suita, Osaka, 565-0871
Argentina5 sites
CIPREC
Buenos Aires, Buenos Aires F.D., C1061
Clínica Universitaria Reina Fabiola
Córdoba, X5004FHP
Instituto de Oncología de Rosario
Rosario, Santa Fe Province, S2000KZE
Centro Para la Atención Integral del Paciente Oncologico (CAIPO)
San Miguel de Tucumán, Tucumán Province, 4000
Clinica Viedma S. A
Viedma, Río Negro Province, R8500ACE
Mexico4 sites
COI Centro Oncologico Internacional S.A.P.I. de C.V.
Mexico City, Mexico City, 04700
Filios Alta Medicina S.A. de C.V.
Monterrey, Nuevo León, 64460
Oaxaca Site Management Organization S.C.
Oaxaca City, 68000
Instituto Veracruzano en Investigación Clínica S.C.
Veracruz, 91851
Turkey (Türkiye)4 sites
Gulhane Egitim Arastirma Hastanesi
Ankara, 06010
Ultramar Medical Imaging Center
Ankara, 06420
Ultramar Medical Imaging Center
Ankara, 06530
Medipol Mega Universite Hastanesi
Stanbul, İ̇stanbul, 34214
Brazil3 sites
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Pernambuco
Recife, Pernambuco, 50070-480
China3 sites
Hunan Cancer Hospital
Changsha, Hunan, 410013
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
South Korea3 sites
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 06273
Ajou University Hospital
Suwon, Kyǒnggi-do, 16499
Canada2 sites
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 5H6
India2 sites
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, 110085
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004
Israel2 sites
Rambam Health Care Campus
Haifa, Northern District, 3109601
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9103102
United Kingdom2 sites
Sarah Cannon Research Institute UK
London, London, CITY of, w1g 6ad
Imperial College Healthcare NHS Trust, Charing Cross Hospital
London, W68RF
About this study
Official title: AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 2 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS AT LEAST 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY (FOURLIGHT-1)
The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body.
This study is seeking female and male participants who:
Read more
- are 18 years of age or older;
- are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative;
- have advanced or metastatic breast cancer after taking other treatments before this study;
- have not taken or need to take medications that are not allowed by the study protocol;
- do not have any medical or mental conditions that may increase the risk of study participation.
Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant. Fulvestrant will be given as a shot into the muscle. The other half will take the study doctor's choice of treatment which can either be:
- Fulvestrant alone taken as shot into the muscle.
- Everolimus along with exemestane taken once daily by mouth.
This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctor's choice of treatment. This will help decide if the study medicine is safe and effective.
Participants will receive study treatment and/or will be in the study until:
- imaging scans (such as an MRI and/or CT) show that their cancer is getting worse.
- the study doctor thinks the participant is no longer benefitting from the study medicine.
- has side effects that become too severe. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take.
- the participant chooses to stop taking part.
- Conditions
- Advanced or Metastatic Breast Cancer
- Being tested
- PF-07220060 CDK4 inhibitor, Fulvestrant, Everolimus, Exemestane
- Keywords
- Estrogen receptor positive [ER(+)], Human epidermal growth factor receptor 2 negative [HER(-)], ER(+)/HER2(-), Advanced Breast Cancer, Breast tumor, Breast cancer, fulvestrant, everolimus, exemestane, Partial Response+ (PR+), Metastatic breast cancer, Hormone Therapy, Hormone positive breast cancer, Recurrent breast cancer, HR+, HER2-negative, Relapse, Recurrent, Second line treatment.
- Medical subject headings
- Breast Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07220060 CDK4 inhibitorDrug
Experimental
FulvestrantDrug
Experimental and Active comparator
EverolimusDrug
Active Comparator
ExemestaneDrug
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | PF-07220060 to be taken by mouth as a tablet in combination with fulvestrant (a solution for injection) Receives: Drug: PF-07220060 CDK4 inhibitor; Drug: Fulvestrant |
| Arm B | Active comparator | Investigator's choice of therapy of either:
* Fulvestrant alone (a solution for injection), or
* Everolimus in combination with exemestane, both a tablet to be taken by mouth. Receives: Drug: Fulvestrant; Drug: Everolimus; Drug: Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) progression, as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: From Initiation up to 2 years
Secondary outcomes (14)
Overall Survival (OS)
Measured: Time from the date of randomization to the date of death due to any cause up to approximately 3 years
OR by investigator per RECIST v1.1
Measured: Time From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression OR death whichever occurs first (up to approximately 2 years)
Duration of Response (DOR) as defined by investigator per RECIST v1.1
Measured: From the date of the first objective response (every 8 weeks during the first 48 weeks and then every 12 week) up to approximately 2 years.
Number of Participants With Clinical Benefit Response (CBR) by investigator per RECIST v1.1
Measured: From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years
Number or Patients with Adverse Events (AEs) by Type
Measured: From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by Incidence
Measured: From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by Seriousness
Measured: From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by relationship to study interventions
Measured: From screening until 28 days after the last dose, to approximately 3 years
Number of Participants With Abnormal Electrocardiogram (ECG)
Measured: From baseline to approximately 2 years
Number of Participants With Laboratory Test Abnormalities
Measured: From screening until 28 days after the last dose to approximately 2 years
EQ-5D-5L
Measured: Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc) and EoT. Each Cycle is 28 days.
EORTC QLQ
Measured: Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc) and EoT. Each Cycle is 28 days.
EORTC QLQ Breast Cancer Module 23 (BR23)
Measured: Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc) and EoT. Each Cycle is 28 days.
Ctrough of PF-07220060
Measured: Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycle 3 (Day 1). Each Cycle is 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start9 Jan 2024
- Primary completion12 Jan 2026
- Study completion21 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105632
- Sponsor's protocol ID
- C4391022
- Other IDs
- 2023-506487-13-00, 2023
- Status last verified
- Aug 2026
- First submitted
- 24 Oct 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 2 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS AT LEAST 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY (FOURLIGHT-1)
- ClinicalTrials.gov ID
- NCT06105632
- Acronym / sponsor ID
- C4391022
- Conditions
- Advanced or Metastatic Breast Cancer
- Keywords
- Estrogen receptor positive [ER(+)], Human epidermal growth factor receptor 2 negative [HER(-)], ER(+)/HER2(-), Advanced Breast Cancer, Breast tumor, Breast cancer, fulvestrant, everolimus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 333 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 21 Jan 2028 (estimated)
- First posted
- 27 Oct 2023 (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.
The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body.
This study is seeking female and male participants who:
- are 18 years of age or older;
- are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative;
- have advanced or metastatic breast cancer after taking other treatments before this study;
- have not taken or need to take medications that are not allowed by the study protocol;
- do not have any medical or mental conditions that may increase the risk of study participation.
Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant. Fulvestrant will be given as a shot into the muscle. The other half will take the study doctor's choice of treatment which can either be:
- Fulvestrant alone taken as shot into the muscle.
- Everolimus along with exemestane taken once daily by mouth.
This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctor's choice of treatment. This will help decide if the study medicine is safe and effective.
Participants will receive study treatment and/or will be in the study until:
- imaging scans (such as an MRI and/or CT) show that their cancer is getting worse.
- the study doctor thinks the participant is no longer benefitting from the study medicine.
- has side effects that become too severe. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take.
- the participant chooses to stop taking part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: PF-07220060 CDK4 inhibitor, Drug: FulvestrantPF-07220060 to be taken by mouth as a tablet in combination with fulvestrant (a solution for injection) |
| Arm B | Active comparator | Drug: Fulvestrant, Drug: Everolimus, Drug: ExemestaneInvestigator's choice of therapy of either: * Fulvestrant alone (a solution for injection), or * Everolimus in combination with exemestane, both a tablet to be taken by mouth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
- Documented estrogen receptor (ER) and/or progesterone receptor (PR)- positive tumor
- Documented HER2-negative tumor
- Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.
- Must have received CDK4/6i plus NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment.
Key exclusion criteria (9 listed)
- Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
- In visceral crisis at risk of immediately life-threatening complications in the short term.
- Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
- Prior treatment with any of the following:
- Everolimus or investigational anti-cancer agents in any setting
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 |
|---|---|---|
| PF-07220060 CDK4 inhibitorExperimental | Drug | Arm A |
| FulvestrantExperimental and Active comparator | Drug | Arm A, Arm B |
| EverolimusActive Comparator | Drug | Arm B |
| ExemestaneActive Comparator | Drug | Arm B |
Primary outcome
Progression-Free Survival (PFS) progression, as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: From Initiation up to 2 years
14 secondary outcomes
Overall Survival (OS)
Time frame: Time from the date of randomization to the date of death due to any cause up to approximately 3 years
OR by investigator per RECIST v1.1
Time frame: Time From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression OR death whichever occurs first (up to approximately 2 years)
Duration of Response (DOR) as defined by investigator per RECIST v1.1
Time frame: From the date of the first objective response (every 8 weeks during the first 48 weeks and then every 12 week) up to approximately 2 years.
Number of Participants With Clinical Benefit Response (CBR) by investigator per RECIST v1.1
Time frame: From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years
Number or Patients with Adverse Events (AEs) by Type
Time frame: From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by Incidence
Time frame: From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by Seriousness
Time frame: From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by relationship to study interventions
Time frame: From screening until 28 days after the last dose, to approximately 3 years
Number of Participants With Abnormal Electrocardiogram (ECG)
Time frame: From baseline to approximately 2 years
Number of Participants With Laboratory Test Abnormalities
Time frame: From screening until 28 days after the last dose to approximately 2 years
EQ-5D-5L
Time frame: Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc) and EoT. Each Cycle is 28 days.
EORTC QLQ
Time frame: Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc) and EoT. Each Cycle is 28 days.
EORTC QLQ Breast Cancer Module 23 (BR23)
Time frame: Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc) and EoT. Each Cycle is 28 days.
Ctrough of PF-07220060
Time frame: Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycle 3 (Day 1). Each Cycle is 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
48 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-07220060 CDK4 inhibitor, Fulvestrant and Everolimus in people with Advanced or Metastatic Breast Cancer, run by Pfizer at 48 sites in 14 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 9 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Japan, Argentina, Mexico, Turkey (Türkiye) and 9 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 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?
This study is still under way. Results are not available in the source record yet.
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) progression, as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: From Initiation up to 2 years). 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 20 Aug 2026.