Breast CancerPhase 1/2NCT03366844
Breast Cancer Study of Preoperative Pembrolizumab + Radiation
A Phase 1/2 study testing Pembrolizumab and RT Boost in people with Breast Cancer, run by Stephen Shiao at 1 site in United States.
Trial summary
This study is being done to assess the feasibility of pembrolizumab (study drug) combined with standard radiation to the tumor (tumor boost) before patients undergo standard treatment that can consist of one or more of the following: breast-conserving surgery, radiation to the entire breast/chest wall after surgery… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pembrolizumab and RT Boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2017to 7 Dec 2030
- Phase
- Phase 1/2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed histologic diagnosis of invasive adenocarcinoma of the breast, and
- ER, PR and HER2 testing (on outside or Cedars-Sinai biopsy report), and
- High-risk, ER-positive and HER2-negative breast cancer patients. ER-positive disease is defined as ER>10%, any PR and HER2-negative by ASCO CAP guidelines. High-risk disease will be defined by the presence of at least 2 of the following 3 criteria: histologic grade II-III, Ki-67 > 20%, ER expression < 75% by IHC)
- TNBC patients (defined as ER<10%, PR<10%, HER2-neu 0-1+ by IHC or FISH-negative; or as per MD discretion)
- Operable tumor measuring ≥2 cm in maximal diameter as measured by any available standard of care imaging (mammogram, breast ultrasound, breast MRI)
- Any nodal status
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- Multifocal disease is permitted; largest focus must measure ≥2 cm
- Synchronous bilateral invasive breast cancer is permitted
- No indication of distant metastases
- Breast-conserving therapy is planned
- Tumor amenable to preoperative radiation therapy boost as determined by radiation oncologist
- ECOG performance status score of 0 or 1
- Screening laboratory values must meet the following criteria:
- White blood cells (WBCs) ≥ 2000/μL ii. Absolute neutrophil count (ANC) ≥ 1500/μL iii. Platelets ≥ 100 x 103/μL iv. Hemoglobin ≥ 11.0 g/dL v. Serum creatinine ≤ 2 mg/dL (or glomerular filtration rate ≥ 40 ml/min) vi. AST ≤ 2.5 x upper limit of normal (ULN) vii. ALT ≤ 2.5 x ULN viii. Total bilirubin within normal limits (except subjects with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL) ix. INR ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulant(s) x. Negative HIV screening test xi. Negative screening tests for Hepatitis B and Hepatitis C. Patients with positive results that do not indicate true active or chronic infection may enroll after discussion and consensus agreement by the treating physician and principal investigator.
- Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for at least 4 months after the last dose of pembrolizumab in such a manner that the risk of pregnancy is minimized.
- WOCBP must have a negative serum pregnancy test within 14 days prior to the first dose of pembrolizumab.
- Women must not be breastfeeding.
- Willingness to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
- Willingness to undergo mandatory Week 4 research biopsy
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Who cannot join
- HER2-positive breast cancer defined as IHC3+ or IHC2+ with FISH>2 AND copy number >4 OR FISH <2 AND copy number >6
- Inflammatory breast cancer
- Contraindication(s) to breast-conserving therapy
- Contraindication to radiation therapy or planned partial breast irradiation
- Patients with cosmetic breast augmentations, specifically sub glandular implants with altered breast tissue, at the time of diagnosis
- Evidence of metastatic disease.
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- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Medical history and concurrent diseases
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Active infection requiring systemic therapy.
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
- Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Known history of Hepatitis B (e.g., HBsAg reactive) or known active Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Prohibited Treatments and/or Therapies
- Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses). However, use of corticosteroids is allowed for the treatment of immune related Adverse Events (irAEs), or adrenal insufficiency.
- Live vaccines within 30 days prior to the first dose of study treatment and while participating in the study. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
- Prior treatment with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)
- Prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study start. Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible. Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- Prior radiotherapy within 2 weeks of start of study treatment to sites outside the breast. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- For subjects who agree to the research breast MRI sub-study: Four or more previous gadolinium contrast scans due to the risk of brain deposits following repeated use of gadolinium-based contrast agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Preoperative Combination of Pembrolizumab and Radiation Therapy in Patients With Operable Breast Cancer
This study is being done to assess the feasibility of pembrolizumab (study drug) combined with standard radiation to the tumor (tumor boost) before patients undergo standard treatment that can consist of one or more of the following: breast-conserving surgery, radiation to the entire breast/chest wall after surgery, and chemotherapy.
Study participants will receive two doses of the study drug intravenously (through the vein) before their planned breast surgery or chemotherapy. The study drug will be administered three weeks apart. At the time of the second dose, radiation to the tumor in the affected breast will be given. This type of radiation treatment is called a "tumor boost", which is a standard part of radiation therapy for breast cancer that may occur either before or after planned breast-conserving surgery. Patients will receive breast surgery or begin chemotherapy approximately six weeks after your first dose of the study drug.
Read the detailed description
With more than 1 million new cases diagnosed yearly worldwide, breast cancer is a global public health burden. Over the past decade, molecular subtyping of breast cancer has identified intrinsic subtypes that may be at enhanced risk for both local and distant recurrence. This study focuses on the immunogenicity of high-risk breast cancer subtypes that are likely to display a dense lymphocytic infiltration including including TNBC and HR+/HER2- tumors.
Immune build up via immune co-stimulatory molecules permits the ensuing immune response to strengthen and destroy cancer systemically. Thus, the effect of the anti-tumor immune response initiated by the radiation to an intact tumor by combination with checkpoint blockade is increased.
Pembrolizumab is an optimal immunotherapy agent to study, as this agent has recently been FDA approved for use in multiple tumor types. It is therefore ready to be tested for efficacy in other disease sites and in combination with other treatments.
- Conditions
- Breast Cancer
- Being tested
- Pembrolizumab, RT Boost
- Keywords
- invasive adenocarcinoma of the breast, ER-positive and HER2-negative breast cancer, Triple negative breast cancer (TNBC), immunotherapy, checkpoint inhibitor, HR-positive
- 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.
PembrolizumabDrug
Also called Keytruda, MK-3475
checkpoint inhibitor
RT BoostRadiation
The second dose of pembrolizumab will be given in conjunction with an RT boost, consisting of 8 Gy for 3 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab with RT Boost | Experimental | Study drug plus "tumor boost" before standard of care treatment Receives: Drug: Pembrolizumab; Radiation: RT Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who do Not Necessitate a Delay in Standard of Care Treatment After Receiving the Investigational Combination of Preoperative Pembrolizumab and Radiation
Feasibility of preoperative radiation and Pembrolizumab in newly diagnosed, non-metastatic patients with triple negative breast cancer.
Measured: 8 weeks after trial initiation
Changes in Tumor Infiltrating Lymphocyte Score (TILs)
An increase in the tumor-infiltrating lymphocyte score (TILs) as measured by Salgado criteria. An increase in TILs is an indicator of immune system engagement (range is 0-100 in percent), therefore increase indicates better outcome. A lead in with pembrolizumab alone followed by the combination of pembrolizumab with RT will allow for serial assessment of TILs. This will establish the contribution of RT to the immune response generated by pembrolizumab. The working group's consensus for Salgado criteria is that TILs may provide more biological relevant information when scored as a continuous variable. The percentage of stromal TILs is a semi quantitative parameter for this assessment (0%-100%). No formal recommendation for a clinically relevant TIL threshold(s) can be given at this stage. The consensus was that a valid methodology is currently more important than issues of thresholds for clinical use, which will be determined once a solid methodology is in place.
Measured: 8 weeks after trial initiation
Secondary outcomes (4)
Pembrolizumab-related Adverse Events
Treatment toxicities. Number of AEs attributed to Pembrolizumab (considered at least possibly related, probably related, or related).
Measured: 15 weeks after trial initiation
Immune-related Adverse Events
Treatment toxicities. Number of immune-related AEs (irAEs).
Measured: Assessed up to one year post-treatment
Invasive Disease-free Survival After Preoperative Radiation and Pembrolizumab
Disease-free survival, as described from time from occurrence of surgery to time from first recurrence from or death from breast cancer
Measured: From treatment start date until date of documented recurrence or death from breast cancer, assessed up to 19 weeks after start of treatment
Pathological Complete Response Rate
Absence of invasive disease in the breast and lymph nodes at the time of curative-intent surgery.
Measured: From treatment start date until the time of curative-intent surgery, approximately 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start22 Dec 2017
- Primary completion6 Feb 2025
- Study completion7 Dec 2030 (estimated)
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm with Two Cohorts 1. Cohort 1: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm 2. Cohort 2: TNBC patients with primary tumors measuring at least 2cm
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen Shiao
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Stephen Shiao, Cedars-Sinai Medical Center
- Investigators
- Stephen Shiao, MD, PHD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366844
- Sponsor's protocol ID
- IIT2017-07-HO-PembroRT
- Status last verified
- Apr 2026
- First submitted
- 25 Nov 2017
- Last updated
- 20 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ho AY, Shiao S, Kobald SA, Chen J, Duda DG, Ly A, Bossuyt V, Cho HL, Arnold B, Knott S, Gupta GP, McAndrew P, Karlan S, Tighiouart M, Muzikansky A, Basho R, McArthur H. PEARL: A Phase Ib/II Biomarker Study of Adding Radiation Therapy to Pembrolizumab Before Neoadjuvant Chemotherapy in Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer. J Clin Oncol. 2024 Dec 20;42(36):4282-4293. doi: 10.1200/JCO.24.00003. Epub 2024 Sep 19.
PubMed 39298718
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Combination of Pembrolizumab and Radiation Therapy in Patients With Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT03366844
- Acronym / sponsor ID
- IIT2017-07-HO-PembroRT
- Conditions
- Breast Cancer
- Keywords
- invasive adenocarcinoma of the breast, ER-positive and HER2-negative breast cancer, Triple negative breast cancer (TNBC), immunotherapy, checkpoint inhibitor, HR-positive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Stephen ShiaoUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 7 Dec 2030 (estimated)
- First posted
- 8 Dec 2017 (actual)
- Results
- Posted 28 Apr 2023
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 being done to assess the feasibility of pembrolizumab (study drug) combined with standard radiation to the tumor (tumor boost) before patients undergo standard treatment that can consist of one or more of the following: breast-conserving surgery, radiation to the entire breast/chest wall after surgery, and chemotherapy.
Study participants will receive two doses of the study drug intravenously (through the vein) before their planned breast surgery or chemotherapy. The study drug will be administered three weeks apart. At the time of the second dose, radiation to the tumor in the affected breast will be given. This type of radiation treatment is called a "tumor boost", which is a standard part of radiation therapy for breast cancer that may occur either before or after planned breast-conserving surgery. Patients will receive breast surgery or begin chemotherapy approximately six weeks after your first dose of the study drug.
Detailed description
With more than 1 million new cases diagnosed yearly worldwide, breast cancer is a global public health burden. Over the past decade, molecular subtyping of breast cancer has identified intrinsic subtypes that may be at enhanced risk for both local and distant recurrence. This study focuses on the immunogenicity of high-risk breast cancer subtypes that are likely to display a dense lymphocytic infiltration including including TNBC and HR+/HER2- tumors.
Immune build up via immune co-stimulatory molecules permits the ensuing immune response to strengthen and destroy cancer systemically. Thus, the effect of the anti-tumor immune response initiated by the radiation to an intact tumor by combination with checkpoint blockade is increased.
Pembrolizumab is an optimal immunotherapy agent to study, as this agent has recently been FDA approved for use in multiple tumor types. It is therefore ready to be tested for efficacy in other disease sites and in combination with other treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm with Two Cohorts 1. Cohort 1: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm 2. Cohort 2: TNBC patients with primary tumors measuring at least 2cm
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab with RT Boost | Experimental | Drug: Pembrolizumab, Radiation: RT BoostStudy drug plus "tumor boost" before standard of care treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Confirmed histologic diagnosis of invasive adenocarcinoma of the breast, and
- ER, PR and HER2 testing (on outside or Cedars-Sinai biopsy report), and
- Operable tumor measuring ≥2 cm in maximal diameter as measured by any available standard of care imaging (mammogram, breast ultrasound, breast MRI)
- Any nodal status
- Multifocal disease is permitted; largest focus must measure ≥2 cm
Key exclusion criteria (23 listed)
- HER2-positive breast cancer defined as IHC3+ or IHC2+ with FISH>2 AND copy number >4 OR FISH <2 AND copy number >6
- Inflammatory breast cancer
- Contraindication(s) to breast-conserving therapy
- Contraindication to radiation therapy or planned partial breast irradiation
- Patients with cosmetic breast augmentations, specifically sub glandular implants with altered breast tissue, at the time of diagnosis
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: Keytruda, MK-3475checkpoint inhibitor | Drug | Pembrolizumab with RT Boost |
| RT BoostThe second dose of pembrolizumab will be given in conjunction with an RT boost, consisting of 8 Gy for 3 fractions. | Radiation | Pembrolizumab with RT Boost |
Primary outcome
Number of Patients Who do Not Necessitate a Delay in Standard of Care Treatment After Receiving the Investigational Combination of Preoperative Pembrolizumab and Radiation
Time frame: 8 weeks after trial initiation
Feasibility of preoperative radiation and Pembrolizumab in newly diagnosed, non-metastatic patients with triple negative breast cancer.
Changes in Tumor Infiltrating Lymphocyte Score (TILs)
Time frame: 8 weeks after trial initiation
An increase in the tumor-infiltrating lymphocyte score (TILs) as measured by Salgado criteria. An increase in TILs is an indicator of immune system engagement (range is 0-100 in percent), therefore increase indicates better outcome. A lead in with pembrolizumab alone followed by the combination of pembrolizumab with RT will allow for serial assessment of TILs. This will establish the contribution of RT to the immune response generated by pembrolizumab. The working group's consensus for Salgado criteria is that TILs may provide more biological relevant information when scored as a continuous variable. The percentage of stromal TILs is a semi quantitative parameter for this assessment (0%-100%). No formal recommendation for a clinically relevant TIL threshold(s) can be given at this stage. The consensus was that a valid methodology is currently more important than issues of thresholds for clinical use, which will be determined once a solid methodology is in place.
4 secondary outcomes
Pembrolizumab-related Adverse Events
Time frame: 15 weeks after trial initiation
Immune-related Adverse Events
Time frame: Assessed up to one year post-treatment
Invasive Disease-free Survival After Preoperative Radiation and Pembrolizumab
Time frame: From treatment start date until date of documented recurrence or death from breast cancer, assessed up to 19 weeks after start of treatment
Pathological Complete Response Rate
Time frame: From treatment start date until the time of curative-intent surgery, approximately 8 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39298718Ho AY, Shiao S, Kobald SA, Chen J, Duda DG, Ly A, Bossuyt V, Cho HL, Arnold B, Knott S, Gupta GP, McAndrew P, Karlan S, Tighiouart M, Muzikansky A, Basho R, McArthur H. PEARL: A Phase Ib/II Biomarker Study of Adding Radiation Therapy to Pembrolizumab Before Neoadjuvant Chemotherapy in Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer. J Clin Oncol. 2024 Dec 20;42(36):4282-4293. doi: 10.1200/JCO.24.00003. Epub 2024 Sep 19.
- 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.
Stephen Shiao, MD, PHD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pembrolizumab and RT Boost in people with Breast Cancer, run by Stephen Shiao at 1 site 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 20 inclusion and 23 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 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 28 Apr 2023). 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?
Number of Patients Who do Not Necessitate a Delay in Standard of Care Treatment After Receiving the Investigational Combination of Preoperative Pembrolizumab and Radiation (time frame: 8 weeks after trial initiation). 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?
On the ClinicalTrials.gov record for NCT03366844, which also lists 1 linked publication.
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 Apr 2026.