Breast CancerPhase 1/2BreastVAXNCT04454528
BreastVAX: Radiation Boost to Enhance Immune Checkpoint Blockade Therapy
A Phase 1/2 study testing Hypofractionated radiotherapy, Pembrolizumab infusion and Blood and tissue sampling in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The primary objective is to determine the feasibility of combining pembrolizumab with a single fraction radiation boost in patients with early/ operable breast cancer. The secondary objectives are to assess clinical response on pre- and post-treatment clinical, imaging, and histology exams, and to assess immune… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hypofractionated radiotherapy, Pembrolizumab infusion and Blood and tissue sampling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2020to Aug 2027
- Phase
- Phase 1/2
- 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
- Men and women age ≥ 18 years old (unless otherwise specified) Willing and able to provide written informed consent/assent ECOG Performance Status 0 - 1
- Patients with:
- Newly diagnosed breast cancer with tumor size < 5 cm who are not eligible for I-SPY2 (to prevent recruitment competition), or not recommended to undergo standard of care neoadjuvant chemotherapy with at least one of the following features:
- Triple negative breast cancer (TNBC) defined using the ASCO CAP guidelines with the following modification supported by a recent publication as ER ≤ 10%, PR ≤ 10%, HER2- determined by immunohistochemistry and/or fluorescence in situ hybridization analyses and with tumor size ≤ 2.5 cm;
- HR+ HER2- breast cancer regardless of nodal status and age of diagnosis ≥ 50
- HR+ HER2- breast cancer and age of diagnosis <50 with tumor size ≤ 2.5 cm and clinically node (+)
Show all 34Show fewer
- HR+ or HR- and HER2+ breast cancer with tumor size ≤ 2.5 cm
- Ductal carcinoma in situ (DCIS) with microinvasion
- OR
- Locally recurrent breast cancer of any receptor subtype with no prior radiation, not recommended to receive neoadjuvant chemotherapy and expecting surgical excision as part of treatment.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 of the study protocol OR
- A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 120 days for study treatments with risk of genotoxicity after the last dose of study treatment.
- Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Medically accepted methods of birth control include a diaphragm, cervical cap, latex condoms, surgical sterility, intrauterine devices (IUDs), hormonal implants, injectable contraceptives, or birth control pills. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Ability to tolerate radiation therapy (e.g., lie flat and hold position)
- Demonstrate adequate hematologic, renal, hepatic, thyroid, and bone marrow function
- Men and women age ≥ 18 years old (unless otherwise specified)
- Willing and able to provide written informed consent/assent
- ECOG Performance Status 0 - 1
- Patients with:
- Newly diagnosed breast cancer with tumor size < 5 cm who are not eligible for I-SPY2 (to prevent recruitment competition), or not recommended to undergo standard of care neoadjuvant chemotherapy with at least one of the following features:
- Triple negative breast cancer (TNBC) defined using the ASCO CAP guidelines with the following modification supported by a recent publication as ER ≤ 10%, PR ≤ 10%, HER2- determined by immunohistochemistry and/or fluorescence in situ hybridization analyses and with tumor size ≤ 2.5 cm;
- HR+ HER2- breast cancer regardless of nodal status and age of diagnosis ≥ 50
- HR+ HER2- breast cancer and age of diagnosis <50 with tumor size ≤ 2.5 cm and clinically node (+)
- HR+ or HR- and HER2+ breast cancer with tumor size ≤ 2.5 cm
- Ductal carcinoma in situ (DCIS) with microinvasion
- OR
- Locally recurrent breast cancer of any receptor subtype with no prior radiation, not recommended to receive neoadjuvant chemotherapy and expecting surgical excision as part of treatment.
- A female participant is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in Appendix 2. OR
- A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 120 days for study treatments with risk of genotoxicity after the last dose of study treatment.
- Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Medically accepted methods of birth control include a diaphragm, cervical cap, latex condoms, surgical sterility, intrauterine devices (IUDs), hormonal implants, injectable contraceptives, or birth control pills. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Ability to tolerate radiation therapy (e.g., lie flat and hold position)
- Demonstrate adequate hematologic, renal, hepatic, thyroid, and bone marrow function
Who cannot join
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- A history of prior radiotherapy to the ipsilateral breast/chest wall that precludes delivery of hypofractionated radiotherapy.
- Has received prior therapy 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).
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks
- Has not adequately recovered from major surgery or has ongoing surgical complications
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
Show all 19Show fewer
- Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)
- Participants with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Participants that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Participants with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study. Steroid prep due to dye allergies prior to staging scans or use in anti-emetic prophylaxis is allowed.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
- Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Note: please refer to Section 5.7 for information on COVID-19 vaccines • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has had an allogenic tissue/solid organ transplant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: Preoperative Use of Radiation Boost to Enhance Effectiveness of Immune Checkpoint Blockade Therapy in Operable Breast Cancer
The primary objective is to determine the feasibility of combining pembrolizumab with a single fraction radiation boost in patients with early/ operable breast cancer. The secondary objectives are to assess clinical response on pre- and post-treatment clinical, imaging, and histology exams, and to assess immune response on pre and post treatment blood and tissue samples by tracking change in Ki67 + CD8 T cells in peripheral blood and in extent of tumor infiltrating lymphocytes. A clinically significant partial response is defined as >30% tumor shrinkage post-clinical trial intervention.
Read the detailed description
The study has four arms. Arms 1 and 2 differ by the order of radiation boost and pembrolizumab administration. A minimum of 6 patients will be enrolled in the safety run-in portion of the study. The Phase 2 portion of the study will include Arm 3 (pembrolizumab only arm). An estimated 27 participants will be enrolled or until futility of Arm 3 is reached. Continuation of enrollment in Arms 1 or 2 will be contingent to funding availability. Arm 4 represents our control arm in which patients will follow usual care but will be consented for blood/tissue collection using a separate protocol (Penn IRB 801539).
- Conditions
- Breast Cancer
- Being tested
- Hypofractionated radiotherapy, Pembrolizumab infusion, Blood and tissue sampling
- Keywords
- Immune checkpoint blockade
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiotherapyRadiation
Also called Radiation therapy
Radiation boost (RT) 7 Gy x 1 fraction on Day -14/Day -7 (arm 1) or Day -7/Day -14
Pembrolizumab infusionDrug
Also called Checkpoint blockade administration
Pembrolizumab infusion flat dosing 200 mg delivered over 30 minutes.
Blood and tissue samplingProcedure or surgery
Also called Correlative studies
Blood will be collected for laboratory studies and complete correlative studies to examine how the subject's immune system is responding to treatment. On day 0, samples of tumor and any lymph nodes removed from armpit will be analyzed by the UPenn Department of Pathology according to standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Arm 1 will receive radiotherapy on day -14 and pembrolizumab on day -7. Subjects in all arms will undergo surgery on day 0 and follow the same postoperative blood sampling and safety schedule. Receives: Radiation: Hypofractionated radiotherapy; Drug: Pembrolizumab infusion; Procedure: Blood and tissue sampling |
| Arm 2 | Active comparator | Arm 2 will receive pembrolizumab on day -14 and radiotherapy on day -7. Subjects in all arms will undergo surgery on day 0 and follow the same postoperative blood sampling and safety schedule. Receives: Radiation: Hypofractionated radiotherapy; Drug: Pembrolizumab infusion; Procedure: Blood and tissue sampling |
| Arm 4 (Historical Controls) | Other | Arm 4 will not receive any study treatment. Subjects will undergo surgery on day 0 and follow a preoperative (Day 0) and postoperative blood (Day 30) and tissue (Day 0) sampling schedule. Receives: Procedure: Blood and tissue sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of preoperative pembrolizumab administration combined with radiation boost in patients with operable breast cancer
Feasibility is defined as patient tolerability of the investigational treatment and no excessive delay in surgery in our participants. The interval to breast-conserving surgery and mastectomy was based on review of our records in patients undergoing breast cancer surgery in 2016. The average time to breast conservation surgery is 24.3 days (80% between 9 and 51 days) and for mastectomy with reconstruction 41.6 days (80% between 10 and 67 days).
Measured: 2 years
Assess clinical response of treatment
Evaluate clinical response using the following assessments:
- Clinical breast exam
- Breast ultrasonography (US) imaging (optional) for tumor dimension changes.
- Histology (pathology) exams. Pathologic response is assess histologically on post-treatment tumor tissues. A major pathologic response will be defined as <10% viable invasive tumor in treated. A clinically significant partial response is defined as >30% tumor shrinkage post-clinical trial intervention.
Measured: 2 years
Secondary outcomes (1)
Assess immune response on pre- and post-treatment blood and tissue samples
Assess immune response on pre- and post-treatment blood and tissue samples This study will track change in Ki67 + CD8 T cells in peripheral blood and in extent of tumor infiltrating lymphocytes (TIL).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start7 Dec 2020
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Tchou, Abramson Cancer Center at Penn Medicine
- Investigators
- Julia C Tchou, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454528
- Sponsor's protocol ID
- UPCC 04119
- Acronym
- BreastVAX
- Status last verified
- Mar 2026
- First submitted
- 22 Jun 2020
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Use of Radiation Boost to Enhance Effectiveness of Immune Checkpoint Blockade Therapy in Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT04454528
- Acronym / sponsor ID
- BreastVAX / UPCC 04119
- Conditions
- Breast Cancer
- Keywords
- Immune checkpoint blockade
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 1 Jul 2020 (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 primary objective is to determine the feasibility of combining pembrolizumab with a single fraction radiation boost in patients with early/ operable breast cancer. The secondary objectives are to assess clinical response on pre- and post-treatment clinical, imaging, and histology exams, and to assess immune response on pre and post treatment blood and tissue samples by tracking change in Ki67 + CD8 T cells in peripheral blood and in extent of tumor infiltrating lymphocytes. A clinically significant partial response is defined as >30% tumor shrinkage post-clinical trial intervention.
Detailed description
The study has four arms. Arms 1 and 2 differ by the order of radiation boost and pembrolizumab administration. A minimum of 6 patients will be enrolled in the safety run-in portion of the study. The Phase 2 portion of the study will include Arm 3 (pembrolizumab only arm). An estimated 27 participants will be enrolled or until futility of Arm 3 is reached. Continuation of enrollment in Arms 1 or 2 will be contingent to funding availability. Arm 4 represents our control arm in which patients will follow usual care but will be consented for blood/tissue collection using a separate protocol (Penn IRB 801539).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Radiation: Hypofractionated radiotherapy, Drug: Pembrolizumab infusion, Procedure: Blood and tissue samplingArm 1 will receive radiotherapy on day -14 and pembrolizumab on day -7. Subjects in all arms will undergo surgery on day 0 and follow the same postoperative blood sampling and safety schedule. |
| Arm 2 | Active comparator | Radiation: Hypofractionated radiotherapy, Drug: Pembrolizumab infusion, Procedure: Blood and tissue samplingArm 2 will receive pembrolizumab on day -14 and radiotherapy on day -7. Subjects in all arms will undergo surgery on day 0 and follow the same postoperative blood sampling and safety schedule. |
| Arm 4 (Historical Controls) | Other | Procedure: Blood and tissue samplingArm 4 will not receive any study treatment. Subjects will undergo surgery on day 0 and follow a preoperative (Day 0) and postoperative blood (Day 30) and tissue (Day 0) sampling schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Men and women age ≥ 18 years old (unless otherwise specified) Willing and able to provide written informed consent/assent ECOG Performance Status 0 - 1
- Newly diagnosed breast cancer with tumor size < 5 cm who are not eligible for I-SPY2 (to prevent recruitment competition), or not recommended to undergo standard of care neoadjuvant chemotherapy with at least one of the following features:
- Triple negative breast cancer (TNBC) defined using the ASCO CAP guidelines with the following modification supported by a recent publication as ER ≤ 10%, PR ≤ 10%, HER2- determined by immunohistochemistry and/or fluorescence in situ hybridization analyses and with tumor size ≤ 2.5 cm;
- HR+ HER2- breast cancer regardless of nodal status and age of diagnosis ≥ 50
- HR+ HER2- breast cancer and age of diagnosis <50 with tumor size ≤ 2.5 cm and clinically node (+)
Key exclusion criteria (19 listed)
- Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- Note: please refer to Section 5.7 for information on COVID-19 vaccines • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
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 |
|---|---|---|
| Hypofractionated radiotherapyAlso: Radiation therapyRadiation boost (RT) 7 Gy x 1 fraction on Day -14/Day -7 (arm 1) or Day -7/Day -14 | Radiation | Arm 1, Arm 2 |
| Pembrolizumab infusionAlso: Checkpoint blockade administrationPembrolizumab infusion flat dosing 200 mg delivered over 30 minutes. | Drug | Arm 1, Arm 2 |
| Blood and tissue samplingAlso: Correlative studiesBlood will be collected for laboratory studies and complete correlative studies to examine how the subject's immune system is responding to treatment. On day 0, samples of tumor and any lymph nodes removed from armpit will be analyzed by the UPenn Department of Pathology according to standard practice. | Procedure or surgery | Arm 1, Arm 2, Arm 4 (Historical Controls) |
Primary outcome
Feasibility of preoperative pembrolizumab administration combined with radiation boost in patients with operable breast cancer
Time frame: 2 years
Feasibility is defined as patient tolerability of the investigational treatment and no excessive delay in surgery in our participants. The interval to breast-conserving surgery and mastectomy was based on review of our records in patients undergoing breast cancer surgery in 2016. The average time to breast conservation surgery is 24.3 days (80% between 9 and 51 days) and for mastectomy with reconstruction 41.6 days (80% between 10 and 67 days).
Assess clinical response of treatment
Time frame: 2 years
Evaluate clinical response using the following assessments: 1. Clinical breast exam 2. Breast ultrasonography (US) imaging (optional) for tumor dimension changes. 3. Histology (pathology) exams. Pathologic response is assess histologically on post-treatment tumor tissues. A major pathologic response will be defined as <10% viable invasive tumor in treated. A clinically significant partial response is defined as >30% tumor shrinkage post-clinical trial intervention.
1 secondary outcome
Assess immune response on pre- and post-treatment blood and tissue samples
Time frame: 2 years
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 10 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Julia C Tchou, MD principal investigator
University of Pennsylvania
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 Hypofractionated radiotherapy, Pembrolizumab infusion and Blood and tissue sampling in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine 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 34 inclusion and 19 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 10 Mar 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?
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?
Feasibility of preoperative pembrolizumab administration combined with radiation boost in patients with operable breast cancer (time frame: 2 years). 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 10 Mar 2026.