Early-stage Breast CancerPhase 1/2NCT07596212
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
A Phase 1/2 study testing Aromatase Inhibitors, Bupropion and GnRH agonist in people with Early-stage Breast Cancer and Hypoactive Sexual Desire Disorder, run by University of Illinois at Chicago at 1 site in United States.
Trial summary
This study is open to women who have early-stage breast cancer and are on aromatase inhibitor (AI) therapy, and who have hypoactive sexual desire disorder (HSDD). HSDD is a persistent lack of physical desire for sex and a lack of sexual activity, or even sexual thoughts or fantasies, that causes you distress. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder, Hormone Receptor Positive Breast Carcinoma
- What is being tested?
- Aromatase Inhibitors, Bupropion and GnRH agonist
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2031
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females 18 or older
- Histologically-proven, resected, hormone receptor-positive (defined as estrogen receptor ≥1% and/or progesterone receptor (PgR)≥1% by immunohistochemistry at local institutions) early invasive breast cancer, stage I-III per American Joint Committee of Cancer (AJCC) 8th edition, regardless of Human Epidermal growth factor Receptor 2 (HER2) status
- Completion of the following planned cancer treatments prior to registration:
- Surgical resection of breast and nodal surgery; (NOTE: Reconstructive surgery does not have to be completed)
- Adjuvant radiation therapy, if needed
- Neoadjuvant and/or adjuvant chemotherapy if needed
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- Treatment with anti-HER2 agents is allowed
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Ability to swallow oral medication.
- Provide written informed consent and fill out questionnaires
- Willing to return to the enrolling institution for follow-up
- Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines. Women of childbearing potential will be required to use effective contraception from the time of consent until 30 days after the last dose of bupropion. Acceptable methods include hormonal contraception, intrauterine device, barrier methods with spermicide, or sterilization
Who cannot join
- Previous bilateral oophorectomy or ovarian irradiation; pregnant or lactating at the time of randomization or desiring pregnancy within 5 years.
- History of psychiatric illnesses on active treatment
- History or active suicidal thoughts or behaviors
- Currently taking anti-depressants, anti-anxiety, or anti-psychotic medications. History of seizure disorder
- History of bulimia or anorexia nervosa
- Inhibitors or inducers of CYP2B6
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- Drugs metabolized by CYP2D6
- Use of monoamine oxidase inhibitors (MAOI)
- History of hypertension, regardless of control status.
- History of angle closure glaucoma
- Subjects taking levodopa, amantadine, methylene blue, and linezolid
- Those with a hypersensitivity to bupropion, anastrozole, letrozole, exemestane, goserelin, or leuprolide. Currently receiving any of the following cancer-directed therapies:
- Radiation therapy
- Systemic therapy such as chemotherapy (standard or investigational)
- Anti-HER2 agents are allowed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
Oana Danciu, MD, (312) 355-1625, ocdanciu@uic.edu
Michelle Karan, (224) 563-7137, makaran2@uic.edu
About this study
This study is open to women who have early-stage breast cancer and are on aromatase inhibitor (AI) therapy, and who have hypoactive sexual desire disorder (HSDD). HSDD is a persistent lack of physical desire for sex and a lack of sexual activity, or even sexual thoughts or fantasies, that causes you distress. The researchers want to determine if sexual functioning, as measured by responses on a sexual functioning questionnaire, is improved by adding Bupropion Extended Release (XL) to the AI treatment regimen. Bupropion XL is an FDA-approved medication for the treatment of major depressive disorder, seasonal affective disorder, and nicotine dependence. It has been studied in HSDD in pre- and post-menopausal healthy women, and has been demonstrated to be effective, but it has not been thoroughly studied in women with early-stage breast cancer on AI therapy.
Read the detailed description
Patients diagnosed with HSDD (defined as Female Sexual Function Index, or FSFI, score ≤ 26) will discontinue their current AI therapy and will be randomized to treatment with a different AI (non-steroidal AI to steroidal AI, or vice versa) plus bupropion 150 mg orally twice a day versus single-agent AI. All patients diagnosed with HSDD will be referred to counseling services and pelvic floor therapy. In addition, patients will be offered access to the Rosy App. FSFI will be administered at months 1, 3, 6, and during the year 3 visit.
- Conditions
- Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder, Hormone Receptor Positive Breast Carcinoma, Breast Cancer
- Being tested
- Aromatase Inhibitors, Bupropion, GnRH agonist
- Medical subject headings
- Breast Neoplasms, Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatase InhibitorsDrug
Also called Letrozole, Anastrozole, Exemestane
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
BupropionDrug
Also called Wellbutrin, Zyban
Bupropion will be taken twice a day by mouth at 150 mg with the option to change to 300 mg daily for those with ongoing HSDD symptoms
GnRH agonistDrug
Also called Leuprolide, Goserelin
A GnRH agonist will be administered for a duration and dose per standard of care as part of ovarian suppression therapy for those who are pre-menopausal. These will be administered subcutaneously every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Single Agent Aromatase Inhibitor and Gonadotropin-Releasing Hormone (GnRH) Agonist | Active comparator | Participants will receive aromatase inhibitor as part of standard of care for early stage breast cancer. The duration of AI therapy will be at the discretion of the investigator.
Patients who are diagnosed with Hypoactive Sexual Desire Disorder at baseline will discontinue their current aromatase inhibitor treatment and switch to a different aromatase inhibitor treatment (i.e., non-steroidal AI to steroidal AI, or vice versa).
Those who are pre-menopausal will also be treated with ovarian suppression therapy (in the form of a GnRH agonist) per standard of care. They will be treated by subcutaneous injection every 28 days and the type, duration, and dose of drug will be per the treating physician's discretion.
Those who have ongoing Hypoactive Sexual Desire Disorder symptoms have the option to crossover to the bupropion arm. Receives: Drug: Aromatase Inhibitors; Drug: GnRH agonist |
| Single Agent Aromatase Inhibitor | Active comparator | Participants will receive aromatase inhibitor as part of standard of care for early stage breast cancer. The duration of AI therapy will be at the discretion of the investigator.
Patients who are diagnosed with Hypoactive Sexual Desire Disorder at baseline will discontinue their current aromatase inhibitor treatment and switch to a different aromatase inhibitor treatment (i.e., non-steroidal AI to steroidal AI, or vice versa).
Those who have ongoing Hypoactive Sexual Desire Disorder symptoms have the option to crossover to the bupropion arm. Receives: Drug: Aromatase Inhibitors |
| Single Agent Aromatase Inhibitor, Gonadotropin-Releasing Hormone (GnRH) Agonist, and Bupropion | Experimental | Participants will receive aromatase inhibitor as part of standard of care for early stage breast cancer plus bupropion 150 mg orally twice daily. The duration of AI therapy will be at the discretion of the investigator.
Patients who are diagnosed with Hypoactive Sexual Desire Disorder at baseline will discontinue their current aromatase inhibitor treatment and switch to a different aromatase inhibitor treatment (i.e., non-steroidal AI to steroidal AI, or vice versa). Patients with Hypoactive Sexual Desire Disorder will also have the option to change their dose to 300 mg orally once a day.
Those who are pre-menopausal will also be treated with ovarian suppression therapy (in the form of a GnRH agonist) per standard of care. They will be treated by subcutaneous injection every 28 days and the type, duration, and dose of drug will be per the treating physician's discretion. Receives: Drug: Aromatase Inhibitors; Drug: Bupropion; Drug: GnRH agonist |
| Single Agent Aromatase Inhibitor and Bupropion | Experimental | Participants will receive aromatase inhibitor as part of standard of care for early stage breast cancer plus bupropion 150 mg orally twice daily. The duration of AI therapy will be at the discretion of the investigator.
Patients who are diagnosed with Hypoactive Sexual Desire Disorder at baseline will discontinue their current aromatase inhibitor treatment and switch to a different aromatase inhibitor treatment (i.e., non-steroidal AI to steroidal AI, or vice versa). Patients with Hypoactive Sexual Desire Disorder will also have the option to change their dose to 300 mg orally once a day. Receives: Drug: Aromatase Inhibitors; Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
To compare the tolerance of aromatase inhibitor (+/- ovarian suppression therapy) in comparison to aromatase inhibitor (+/- ovarian suppression therapy) plus bupropion. This is assessed by the proportion of patients no longer meeting HSDD criteria as reflected by FSFI > 26 at three months post-randomization.
Measured: Until 3 months post-study enrollment
Secondary outcomes (4)
Disease free-survival in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
To compare the disease free survival rate of patients taking aromatase inhibitor (+/- ovarian suppression therapy) to those taking aromatase inhibitor therapy (+/- ovarian suppression therapy) plus bupropion. This is assessed by the time since treatment end to the date of disease progression, death, or least contact, whichever comes first
Measured: Until 3 years post-study enrollment
Overall survival in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
To compare the overall survival rate of patients taking aromatase inhibitor (+/- ovarian suppression therapy) to those taking aromatase inhibitor therapy (+/- ovarian suppression therapy) plus bupropion. This is defined as the time of treatment randomization to death or last contact in study participants.
Measured: Until 3 years post-study enrollment
Safety and tolerability of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
To determine the safety and tolerability of aromatase inhibitor (+/- ovarian suppression therapy) versus aromatase inhibitor (+/- ovarian suppression therapy) and bupropion as defined by the number of adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: Until 6 months post-study enrollment
Medication adherence of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
To determine the rate of medication adherence for patients taking aromatase inhibitor (+/- ovarian suppression therapy) versus aromatase inhibitor (+/- ovarian suppression therapy) and bupropion. This is defined as the number of medication diary entries and physician queries to treatment.
Measured: Until 3 years post-treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oana Danciu, University of Illinois at Chicago
- Investigators
- Oana Danciu, MD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596212
- Sponsor's protocol ID
- 2025-1138
- Status last verified
- Aug 2026
- First submitted
- 13 May 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
- ClinicalTrials.gov ID
- NCT07596212
- Acronym / sponsor ID
- 2025-1138
- Conditions
- Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder, Hormone Receptor Positive Breast Carcinoma, Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 19 May 2026 (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.
This study is open to women who have early-stage breast cancer and are on aromatase inhibitor (AI) therapy, and who have hypoactive sexual desire disorder (HSDD). HSDD is a persistent lack of physical desire for sex and a lack of sexual activity, or even sexual thoughts or fantasies, that causes you distress. The researchers want to determine if sexual functioning, as measured by responses on a sexual functioning questionnaire, is improved by adding Bupropion Extended Release (XL) to the AI treatment regimen. Bupropion XL is an FDA-approved medication for the treatment of major depressive disorder, seasonal affective disorder, and nicotine dependence. It has been studied in HSDD in pre- and post-menopausal healthy women, and has been demonstrated to be effective, but it has not been thoroughly studied in women with early-stage breast cancer on AI therapy.
Detailed description
Patients diagnosed with HSDD (defined as Female Sexual Function Index, or FSFI, score ≤ 26) will discontinue their current AI therapy and will be randomized to treatment with a different AI (non-steroidal AI to steroidal AI, or vice versa) plus bupropion 150 mg orally twice a day versus single-agent AI. All patients diagnosed with HSDD will be referred to counseling services and pelvic floor therapy. In addition, patients will be offered access to the Rosy App. FSFI will be administered at months 1, 3, 6, and during the year 3 visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single Agent Aromatase Inhibitor and Gonadotropin-Releasing Hormone (GnRH) Agonist | Active comparator | Drug: Aromatase Inhibitors, Drug: GnRH agonistParticipants will receive aromatase inhibitor as part of standard of care for early stage breast cancer. The duration of AI therapy will be at the discretion of the investigator. Patients who are diagnosed with Hypoactive Sexual Desire Disorder at baseline will discontinue their current aromatase inhibitor treatment and switch to a different aromatase inhibitor treatment (i.e., non-steroidal AI to steroidal AI, or vice versa). Those who are pre-menopausal will also be treated with ovarian suppression therapy (in the form of a GnRH agonist) per standard of care. They will be treated by subcutaneous injection every 28 days and the type, duration, and dose of drug will be per the treating physician's discretion. Those who have ongoing Hypoactive Sexual Desire Disorder symptoms have the option to crossover to the bupropion arm. |
| Single Agent Aromatase Inhibitor | Active comparator | Drug: Aromatase InhibitorsParticipants will receive aromatase inhibitor as part of standard of care for early stage breast cancer. The duration of AI therapy will be at the discretion of the investigator. Patients who are diagnosed with Hypoactive Sexual Desire Disorder at baseline will discontinue their current aromatase inhibitor treatment and switch to a different aromatase inhibitor treatment (i.e., non-steroidal AI to steroidal AI, or vice versa). Those who have ongoing Hypoactive Sexual Desire Disorder symptoms have the option to crossover to the bupropion arm. |
| Single Agent Aromatase Inhibitor, Gonadotropin-Releasing Hormone (GnRH) Agonist, and Bupropion | Experimental | Drug: Aromatase Inhibitors, Drug: Bupropion, Drug: GnRH agonistParticipants will receive aromatase inhibitor as part of standard of care for early stage breast cancer plus bupropion 150 mg orally twice daily. The duration of AI therapy will be at the discretion of the investigator. Patients who are diagnosed with Hypoactive Sexual Desire Disorder at baseline will discontinue their current aromatase inhibitor treatment and switch to a different aromatase inhibitor treatment (i.e., non-steroidal AI to steroidal AI, or vice versa). Patients with Hypoactive Sexual Desire Disorder will also have the option to change their dose to 300 mg orally once a day. Those who are pre-menopausal will also be treated with ovarian suppression therapy (in the form of a GnRH agonist) per standard of care. They will be treated by subcutaneous injection every 28 days and the type, duration, and dose of drug will be per the treating physician's discretion. |
| Single Agent Aromatase Inhibitor and Bupropion | Experimental | Drug: Aromatase Inhibitors, Drug: BupropionParticipants will receive aromatase inhibitor as part of standard of care for early stage breast cancer plus bupropion 150 mg orally twice daily. The duration of AI therapy will be at the discretion of the investigator. Patients who are diagnosed with Hypoactive Sexual Desire Disorder at baseline will discontinue their current aromatase inhibitor treatment and switch to a different aromatase inhibitor treatment (i.e., non-steroidal AI to steroidal AI, or vice versa). Patients with Hypoactive Sexual Desire Disorder will also have the option to change their dose to 300 mg orally once a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Females 18 or older
- Histologically-proven, resected, hormone receptor-positive (defined as estrogen receptor ≥1% and/or progesterone receptor (PgR)≥1% by immunohistochemistry at local institutions) early invasive breast cancer, stage I-III per American Joint Committee of Cancer (AJCC) 8th edition, regardless of Human Epidermal growth factor Receptor 2 (HER2) status
- Completion of the following planned cancer treatments prior to registration:
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Ability to swallow oral medication.
Key exclusion criteria (15 listed)
- Previous bilateral oophorectomy or ovarian irradiation; pregnant or lactating at the time of randomization or desiring pregnancy within 5 years.
- History of psychiatric illnesses on active treatment
- History or active suicidal thoughts or behaviors
- Currently taking anti-depressants, anti-anxiety, or anti-psychotic medications. History of seizure disorder
- History of bulimia or anorexia nervosa
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 |
|---|---|---|
| Aromatase InhibitorsAlso: Letrozole, Anastrozole, ExemestaneAn aromatase inhibitor will be given at a duration, frequency, and dose per standard of care. | Drug | Single Agent Aromatase Inhibitor, Single Agent Aromatase Inhibitor and Bupropion, Single Agent Aromatase Inhibitor and Gonadotropin-Releasing Hormone (GnRH) Agonist, Single Agent Aromatase Inhibitor, Gonadotropin-Releasing Hormone (GnRH) Agonist, and Bupropion |
| BupropionAlso: Wellbutrin, ZybanBupropion will be taken twice a day by mouth at 150 mg with the option to change to 300 mg daily for those with ongoing HSDD symptoms | Drug | Single Agent Aromatase Inhibitor and Bupropion, Single Agent Aromatase Inhibitor, Gonadotropin-Releasing Hormone (GnRH) Agonist, and Bupropion |
| GnRH agonistAlso: Leuprolide, GoserelinA GnRH agonist will be administered for a duration and dose per standard of care as part of ovarian suppression therapy for those who are pre-menopausal. These will be administered subcutaneously every 28 days. | Drug | Single Agent Aromatase Inhibitor and Gonadotropin-Releasing Hormone (GnRH) Agonist, Single Agent Aromatase Inhibitor, Gonadotropin-Releasing Hormone (GnRH) Agonist, and Bupropion |
Primary outcome
Tolerance of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
Time frame: Until 3 months post-study enrollment
To compare the tolerance of aromatase inhibitor (+/- ovarian suppression therapy) in comparison to aromatase inhibitor (+/- ovarian suppression therapy) plus bupropion. This is assessed by the proportion of patients no longer meeting HSDD criteria as reflected by FSFI > 26 at three months post-randomization.
4 secondary outcomes
Disease free-survival in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
Time frame: Until 3 years post-study enrollment
Overall survival in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
Time frame: Until 3 years post-study enrollment
Safety and tolerability of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
Time frame: Until 6 months post-study enrollment
Medication adherence of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
Time frame: Until 3 years post-treatment start
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 24 Aug 2026.
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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.
Oana Danciu, MD principal investigator
University of Illinois at Chicago
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 Aromatase Inhibitors, Bupropion and GnRH agonist in people with Early-stage Breast Cancer and Hypoactive Sexual Desire Disorder, run by University of Illinois at Chicago 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 12 inclusion and 15 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: opening soon, as of the sponsor's last update on 24 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 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?
Contact Oana Danciu, MD ((312) 355-1625, ocdanciu@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder (time frame: Until 3 months post-study enrollment). 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 24 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.