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Breast CancerPhase 3NCT04851613

Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer

A Phase 3 study testing Afuresertib in people with Breast Cancer, run by Laekna Limited at 55 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Study LAE205INT3101 is a Phase Ib/III study to evaluate the efficacy and safety of the combination therapy with afuresertib plus fulvestrant (afuresertib/placebo plus fulvestrant in Phase III) in patients with HR+/HER2- breast cancer who have failed 1 to 2 prior lines of endocrine therapy, and/or CDK4/6 inhibitor (up… 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?
Afuresertib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
256 participants
Where
55 sitesin 2 countries
Study dates
18 Feb 2022to 30 Dec 2026
Phase
Phase 3
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

  • Female or male patients must be ≥ 18 years of age on the day of signing the informed consent and be able to provide written informed consent for the study.
  • Patients with histologically or cytologically confirmed HR+/HER2- Breast Cancer characterized by the absence of HER2 expression and the presence of ER with/without PR expression.
  • Female patients may be post-menopausal, pre-menopausal or peri-menopausal. Male and Pre- and peri-menopausal females may be enrolled if continuously treated with ovarian suppression therapy (use LHRHa at least starting from C1D1) for the duration of study participation.
  • Before enrollment, patients who have undergone anti-cancer treatment must have a washout period of 4 weeks or 5 half-lives, whichever comes earlier.
  • HR+/HER2- BC patients must meet all the following criteria to join this study:
  • Relapsed locally advanced (LABC) or metastatic (mBC) disease; AND
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  • Have received 1 to 2 prior lines of systemic treatments for LABC or mBC(at least one line was ET). If disease relapse during adjuvant therapy or relapse within 12 months from completion of adjuvant endocrine therapy, the adjuvant therapy will be counted as 1 line), including:
  • Endocrine therapies including AIs and/or SERMs (1 or 2 lines) with or without a CDK4/6 inhibitor (up to 1 therapy); OR ii. A chemotherapy (monotherapy or combination therapy, at most 1 line only), with 1 additional line of endocrine therapy .
  • For phase Ib part, patients must have at least one lesion that meets the definition of measurable disease by RECIST 1.1 criteria; for phase III, have measurable disease and/or at least 1 lytic or mixed (lytic + sclerotic) bone lesion that can be assessed by RECIST 1.1 criteria; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible (Appendix 2).
  • In the Phase Ib part, Patients must provide informed consent for the procedures and the tests for PIK3CA/AKT/PTEN alterations and ESR1 mutations. The biomarkers will be tested retrospectively by gene sequencing tests using archival tumor sample (preferably within 18 months/78 weeks) or from peripheral blood or from a tumor biopsy sample. Formalin-fixed, paraffin embedded (FFPE) tissue blocksare preferred. In phase III, blood sample is mandatory for this test.
  • In Phase III, subjects need to provide blood sample during the screening period for PIK3CA/AKT1/PTEN test, which will be conducted in the central laboratory. Only patients with PIK3CA/AKT1/PTEN alterations could include.
  • Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
  • Patients who have adequate organ function as defined.
  • Patients without a pre-existing diagnosis of diabetes mellitus (DM) who have a fasting glucose ≤ 126 mg/dL (or ≤ 7.0 mmol/L); or patients with type 2 diabetes who have a fasting glucose ≤ 167 mg/dL (or ≤ 9.3 mmol/L) AND glycosylated hemoglobin (HbA1c) ≤ 8%. Patients with DM type 1 or patients with DM type 2 requiring insulin or ≥21 anti-abetic medications for glycemic control are excluded.
  • Patients with a life expectancy of 24 weeks or more based on investigator's assessment.
  • Patients who have recovered from adverse events associated with pre-study medical, radiation and surgical treatments to ≤ Grade 1, excluding stable symptoms (e.g., alopecia, peripheral sensory neuropathy, skin hyperpigmentation, dysgeusia, etc.).
  • Female patients of childbearing potential must have a negative pretreatment serum pregnancy test.
  • Female patients of childbearing potential must agree to use effective contraception from enrollment to 1 year after discontinuation from the last dose of this study treatment.
  • Patients who are able to swallow and retain oral medication and without gastrointestinal diseases to interfere with drug absorption.
  • Patients must have no contraindications to fulvestrant.

Who cannot join

  • Patients who had a recent major surgery that required hospitalization for longer than 48 hours (< 8 weeks from scheduled treatment starting date) or have used IV antibiotics for the treatment of systemic infection (< 2 weeks from scheduled treatment starting date).
  • Patients who have additional known malignancies that are progressing or have required active treatments within 3 years of scheduled treatment starting date. (Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, that have undergone potentially curative therapy are not excluded).
  • Patients who have a history of seizure or conditions that may predispose them to seizure and require anti-epileptic medications, or patients who have brain arteriovenous malformation, or intracranial masses that are causing edema or clinical symptoms.
  • Patients who have known active CNS metastases and/or carcinomatous meningitis. (Note: Patients with previously treated brain metastases may participate provided that they are radiologically stable (i.e., without evidence of progression for at least 4 weeks by repeated imaging performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to schedule treatment starting date.
  • Patients who had prior treatment with fulvestrant or other selective estrogen receptor degraders (SERDs), or any PI3K/AKT/mTOR inhibitors, or any CDK4/6 inhibitors in phase I, II study.
  • Patients who had the following conditions within 6 months (26 weeks) of scheduled treatment starting date: New York Heart Association congestive heart failure classification III to IV, unstable angina, myocardial infarction, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or serious cardiac arrhythmia associated with significant cardiovascular impairment as determined by the investigator.
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  • Patients with QT interval corrected by the Frederica's correction formula (QTcF) > 470 msec(average value), unless the prolonged QT interval is due to (right or left) bundle branch block and/or pacemaker rhythm. If wide QRS complex is present, cardiology consultation is required to assess the risk for Torsade de Pointes. Note: QTcF = QT/(RR^0.33) .
  • Patients who have uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg under anti-hypertensive treatment). Note: Patients with a history of hypertension are allowed, provided that blood pressure is controlled to within these limits by anti-hypertensive treatment.
  • Patients with active Hepatitis B infection [defined as HBsAg (+) and HBV-DNA ≥ 200 IU/ml (1000 copy/ml)] or active Hepatitis C virus [defined as HCV antibody positive and HCV RNA (qualitative) test positive].
  • Patients with known HIV seropositivity who has 1 of the following:
  • Not receiving highly active antiretroviral therapy
  • Receiving antiretroviral therapy that may interfere with the study drug (consult the Sponsor/Medical Monitor for review of medication prior to enrollment)
  • CD4 count < 350 based on a test within 3 months of the screening visit
  • An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months (26 weeks) of the start of study screening
  • Patients who have a history or current evidence of any condition, therapy, or laboratory abnormality that in the opinion of the investigator, might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate.
  • Patients who have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
  • Patients who are receiving medications that are sensitive substrates of CYP3A4, OATP1B1, or BCRP with low therapeutic index. Please see related section for a list of these prohibited medications.
  • Patients who are currently pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 1 year after the last dose of study treatment.
  • Patients who have known cirrhosis with a Child-Pugh status of B and C.
  • Patients who are ineligible for endocrine therapy (e.g., visceral crisis, inflammatory breast cancer, uncontrolled pleural or abdominal fluid drainage ≥4 times within one month before planned administration).

Trial locations and contacts

55 sites in 2 countries.

55 sites in 2 countries

China49 sites

  • Anyang cancer hospital

    Anyang, Henan, 455000

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 071000

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking Union Medical College Hospital (PUMCH)

    Beijing, Beijing Municipality, 100730

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

  • The first hospital of Jilin University

    Changchun, Jilin, 130000

  • Jilin Provincial Cancer Hospital

    Changchun, Jilin, 130012

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 528000

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Sun Yat-sen Memorial Hospital，Sun Yat-sen University

    Guangzhou, Guangdong, 510000

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510050

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Sir-run shaw Hospital Zhejiang University of Medicine

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230031

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, 210029

  • Guangxi Zhuang Autonomous Region People's Hospital

    Nanning, Guangxi, 530021

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu

  • Ningbo Li Huili Hospital

    Ningbo, Zhejiang, 315040

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200020

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110000

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Taizhou Hospital

    Taizhou, Zhejiang, 317000

  • Tangshan People's Hospital

    Tangshan, Hebei, 063000

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Wuhan Central Hospital

    Wuhan, Hubei, 430022

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Zhongshan People's Hospital

    Zhongshan, Guangdong, 528403

Other trials in China

United States6 sites

  • Piedmont Cancer Institute

    Atlanta, Georgia, 30318

  • University of Vermont

    Burlington, Vermont, 05401

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Providence St. Johns Health Center

    Santa Monica, California, 90404

Other trials in United States

About this study

Official title: A Phase Ib/III Study to Evaluate the Efficacy and Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Failed Standard of Care Therapies

Study LAE205INT3101 is a Phase Ib/III study to evaluate the efficacy and safety of the combination therapy with afuresertib plus fulvestrant (afuresertib/placebo plus fulvestrant in Phase III) in patients with HR+/HER2- breast cancer who have failed 1 to 2 prior lines of endocrine therapy, and/or CDK4/6 inhibitor (up to 1 therapy), and/or chemotherapy (up to 1 chemotherapy) as described in the inclusion criteria.

Read the detailed description

Eligible patients for this study must have either (1) progressive disease whilst receiving an endocrine therapy (AI or a SERM), and/or a CDK4/6 inhibitor for locally advanced or metastatic disease; or (2) relapsed with metastatic disease whilst receiving an ET (AI or SERM), and/or a CDK4/6 inhibitor, and/or chemotherapy in adjuvant setting. No more than 2 prior lines of systemic treatments for locally advanced or metastatic disease are allowed for this study, including 1-2 prior lines of endocrine therapy, with/without CDK4/6 inhibitor (up to 1 therapy), and/or chemotherapy (up to 1 therapy).

Conditions
Breast Cancer
Being tested
Afuresertib, Afuresertib/placebo
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfuresertibDrug

    Also called Fulvestrant

    The starting doses of the combination therapy are afuresertib 125 mg PO, QD plus fulvestrant 500 mg IM, D1, 15 in the first cycle and afuresertib 125 mg PO, QD plus fulvestrant 500 mg IM, D1 Q4W in the subsequent cycles

  • Afuresertib/placeboDrug

    Also called Fulvestrant

    afuresertib/placebo 125mg QD combined with fulvestrant 500mg Q4W (D1, 15 in cycle 1)

Study groups in NCT04851613
Study groupRoleWhat they receive
Phase I: Afuresertib and Fulvestrant Safety Run InExperimentalPhase I: Safety run-in Cycle 1 (a cycle is 28 days) will be performed in the first 6 patients of the phase Ib. Combination regimens during the safety run-in period are: afuresertib 125 mg QD (once daily) + fulvestrant 500 mg Intra Muscular (IM) on Day 1, 15 of Cycle 1, and on Day 1 of the subsequent 28-day cycles.
Receives: Drug: Afuresertib
Phase I: Afuresertib and FulvestrantExperimentalPhase I: Combination regimens are: afuresertib 125 mg QD (once daily) + fulvestrant 500 mg Intra Muscular (IM) on Day 1, 15 of Cycle 1, and on Day 1 of the subsequent 28-day cycles.
Receives: Drug: Afuresertib
Phase III: afuresertib combined with fulvestrant (experimental arm)ExperimentalPhase III: afuresertib 125mg QD combined with fulvestrant 500mg Q4W (D1, 15 in cycle 1)
Receives: Drug: Afuresertib
Phase III: placebo combined with fulvestrant (control arm)Placebo comparatorPhaseIII：placebo combined with fulvestrant 500mg Q4W (D1, 15 in cycle 1)
Receives: Drug: Afuresertib/placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Overall Response Rate (ORR) based on RECIST 1.1

    Phase I: Anti-tumor activity of the combination therapy with afuresertib plus fulvestrant in patients with HR+/HER2- BC

    Measured: Phase I: Change from Baseline beginning at Cycle 3 Day 1 and then every 8 weeks × 40 weeks then every 3 months through study completion, an average of 1 year (each cycle is 28 days)

  2. Phase III: Progression Free Survival (PFS) based on RECIST 1.1, as assessed by investigators

    Phase III:To assess the anti-tumor activity of the combination therapy with afuresertib plus fulvestrant versus placebo plus fulvestrant in patients with PIK3CA/AKT1/PTEN alterations HR+/HER2- BC who have failed 1 to 2 prior lines of ET with/without a Phase III: CDK4/6 inhibitor (up to 1 therapy), or chemotherapy (up to 1 chemotherapy)

    Measured: Phase III:Change from Baseline beginning at Cycle 3 Day 1 and then every 8 weeks for the first 12 months, then every 3 months through study completion

Secondary outcomes (11)

  1. Phase I: Duration of Response (DOR) based on RECIST 1.1

    Phase I: Anti-tumor activity of the combination therapy with afuresertib plus fulvestrant in patients with HR+/HER2- BC

    Measured: Phase I: Change from Baseline beginning at Cycle 3 Day 1 and then every 8 weeks x 40 weeks then every 3 months through study completion, an average of 1 year (each cycle is 28 days)

  2. Phase I: Clinical rate of benefit (CBR) based on RECIST 1.1

    Phase I: Anti-tumor activity of the combination therapy with afuresertib plus fulvestrant in patients with HR+/HER2- BC

    Measured: Phase I: Change from Baseline beginning at Cycle 3 Day 1 and then every 8 weeks x 40 weeks then every 3 months through study completion, an average of 1 year (each cycle is 28 days)

  3. Phase I: Best Overall Response (BOR) based on RECIST 1.1

    Phase I: Anti-tumor activity of the combination therapy with afuresertib plus fulvestrant in patients with HR+/HER2- BC

    Measured: Phase I: Change from Baseline beginning at Cycle 3 Day 1 and then every 8 weeks x 40 weeks then every 3 months through study completion, an average of 1 year (each cycle is 28 days)

  4. Phase I: Progression Free Survival (PFS) based on RECIST 1.1

    Phase I: Anti-tumor activity of the combination therapy with afuresertib plus fulvestrant in patients with HR+/HER2- BC

    Measured: Phase I: After Cycle 3 Day 1 and then every 8 weeks x 40 weeks then every 3 months through study completion, an average of 1 year (each cycle is 28 days)

  5. Phase I: Pharmacokinetics- Time to Maximum Concentration (T-Max)

    Phase I: Time to peak level of afuresertib

    Measured: Phase I: Assessed on Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)

  6. Phase I: Pharmacokinetics- Area Under the Curve (AUC)

    Area under the curve of afuresertib

    Measured: Assessed on Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)

  7. Phase I: Frequency and severity of Adverse Events (AEs)

    Phase I: findings on physical examination, ECG, vital signs, and reports of the laboratory results based on the CTCAE v5.0

    Measured: Phase I: Through study completion for an average of 12 months

  8. Phase III: Progression Free Survival (PFS) based on RECIST 1.1, as assessed by BICR

    Phase III: Anti-tumor activity of the combination therapy with afuresertib plus fulvestrant in patients with HR+/HER2- BC

    Measured: Phase III:Change from Baseline beginning at Cycle 3 Day 1 and then every 8 weeks for the first 12 months then every 3 months through study completion

  9. Phase III：Frequency and severity of Adverse Events (AEs)

    Phase III：findings on physical examination, ECG, vital signs, and reports of the laboratory results based on the CTCAE v5.0

    Measured: Phase III：Through study completion

  10. Phase III：Pharmacokinetics- Time to Maximum Concentration (T-Max)

    Time to peak level of afuresertib

    Measured: Assessed on Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)

  11. Phase III：Pharmacokinetics- Area Under the Curve (AUC)

    Area under the curve of afuresertib

    Measured: Assessed on Day 1 and Day 15 of Cycle 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.

  1. First posted20 Apr 2021
  2. Study start18 Feb 2022
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase I: Single-arm, open-label study to evaluate efficacy, safety, tolerability, PK of the therapy with afuresertib plus fulvestrant. Phase III: A multi-center, randomized, double-blind, placebo-controlled study to assess efficacy and safety of afuresertib/placebo plus fulvestrant in patients with HR+/HER2- locally advanced or metastatic BC who have failed 1 to 2 prior lines of ET with/without a CDK4/6 inhibitor (up to 1 therapy), or chemotherapy (up to 1 chemotherapy).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
256 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04851613
Sponsor's protocol ID
LAE205INT3101
Status last verified
Mar 2026
First submitted
13 Apr 2021
Last updated
2 Apr 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Zhang P, Sun T, Wang Y, Li W, Tong Z, Phadke S, Feinstein T, Ma W, Guo P, Zhang M, Yue Y, Xu B. Afuresertib plus fulvestrant for pretreated HR-positive, HER2-negative, advanced breast cancer: a phase Ib trial. Nat Commun. 2026 Feb 6;17(1):2456. doi: 10.1038/s41467-026-69225-2.

    PubMed 41651834

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Afuresertib in people with Breast Cancer, run by Laekna Limited at 55 sites in 2 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 20 inclusion and 20 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 2 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 55 sites in China, 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

Phase I: Overall Response Rate (ORR) based on RECIST 1.1 (time frame: Phase I: Change from Baseline beginning at Cycle 3 Day 1 and then every 8 weeks × 40 weeks then every 3 months through study completion, an average of 1 year (each cycle is 28 days)). 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 NCT04851613, 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 2 Apr 2026.

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