ClinicalTrials.gg
Active, not recruitingNCT04851613Updated Apr 2, 2026

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

A Phase 3 interventional study of Afuresertib and Afuresertib/placebo in Breast Cancer, sponsored by Laekna Limited. Active, not recruiting at 55 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by Laekna Limited · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Breast Cancer

Browse trials for

03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 256 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Laekna Limited is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Female or male patients must be ≥ 18 years of age on the day of signing the and be able to provide written informed consent for the study.
  2. Patients with or cytologically confirmed HR+/- Breast Cancer characterized by the absence of HER2 expression and the presence of ER with/without PR expression.
  3. Female patients may be , 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.
  4. Before enrollment, patients who have undergone anti-cancer treatment must have a of 4 weeks or 5 half-lives, whichever comes earlier.
  5. HR+/HER2- BC patients must meet all the following criteria to join this study:

    1. locally advanced (LABC) or (mBC) disease; AND
    2. Have received 1 to 2 for LABC or mBC(at least one line was ET). If disease relapse during therapy or relapse within 12 months from completion of adjuvant endocrine therapy, the adjuvant therapy will be counted as 1 line), including:

    i. 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 .

  6. For phase Ib part, patients must have at least one lesion that meets the definition of by 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).
  7. 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 (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.
  8. 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.
  9. Patients with an (ECOG) Performance Score of 0 or 1.
  10. Patients who have adequate organ function as defined.
  11. 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 () ≤ 8%. Patients with DM type 1 or patients with DM type 2 requiring insulin or ≥21 anti-abetic medications for glycemic control are excluded.
  12. Patients with a of 24 weeks or more based on investigator's assessment.
  13. 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.).
  14. Female patients of must have a negative pretreatment serum pregnancy test.
  15. Female patients of childbearing potential must agree to use effective from enrollment to 1 year after discontinuation from the last dose of this study treatment.
  16. Patients who are able to swallow and retain oral medication and without gastrointestinal diseases to interfere with drug absorption.
  17. Patients must have no to fulvestrant.

Exclusion criteria

Exclusion Criteria:

  1. 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).
  2. Patients who have additional known 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).
  3. 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.
  4. Patients who have known active 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 treatment for at least 14 days prior to schedule treatment starting date.
  5. 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.
  6. Patients who had the following conditions within 6 months (26 weeks) of scheduled treatment starting date: congestive heart failure classification III to IV, unstable angina, myocardial infarction, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including ), or serious cardiac arrhythmia associated with significant cardiovascular impairment as determined by the investigator.
  7. Patients with 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) .
  8. 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.
  9. Patients with active infection [defined as HBsAg (+) and HBV-DNA ≥ 200 IU/ml (1000 copy/ml)] or active virus [defined as HCV antibody positive and HCV RNA (qualitative) test positive].
  10. Patients with known seropositivity who has 1 of the following:

    1. Not receiving highly active antiretroviral therapy
    2. Receiving antiretroviral therapy that may interfere with the study drug (consult the Sponsor/Medical Monitor for review of medication prior to enrollment)
    3. \< 350 based on a test within 3 months of the screening visit
    4. An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months (26 weeks) of the start of study screening
  11. 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.
  12. 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.
  13. Patients who are receiving medications that are sensitive substrates of , OATP1B1, or BCRP with low therapeutic index. Please see related section for a list of these prohibited medications.
  14. 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.
  15. Patients who have known cirrhosis with a status of B and C.
  16. 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).
Terms in these criteria, in plain language(31)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
256 participants (estimated)

Study arms

  • Experimental
    Phase I: Afuresertib and Fulvestrant Safety Run In

    Phase 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.

    Drug: Afuresertib

  • Experimental
    Phase I: Afuresertib and Fulvestrant

    Phase 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.

    Drug: Afuresertib

  • Experimental
    Phase III: afuresertib combined with fulvestrant (experimental arm)

    Phase III: afuresertib 125mg QD combined with fulvestrant 500mg Q4W (D1, 15 in cycle 1)

    Drug: Afuresertib

  • Placebo comparator
    Phase III: placebo combined with fulvestrant (control arm)

    PhaseIII:placebo combined with fulvestrant 500mg Q4W (D1, 15 in cycle 1)

    Drug: Afuresertib/placebo

Interventions

  • 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

    Also known as: Fulvestrant

  • DrugAfuresertib/placebo

    Drug page: Fulvestrant

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

    Also known as: Fulvestrant

06

What researchers measure

Primary outcomes

  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

    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)

  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)

    Time frame: 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

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Phase III:Through study completion

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

    Time to peak level of afuresertib

    Time frame: 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

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

07

Study locations

55 sites
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2022 (actual). Primary completion is estimated for Oct 2026, 56 months after the start.

Of 272 industry-sponsored phase 3 interventional studies under Breast Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 63. This study's planned 56 months is above that.

Counting every sponsor, half of 600 studies reached it within 59 months; a quarter within 36 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 13, 2021
First posted
Apr 20, 2021
StartActual
Feb 18, 2022
Primary completionEst.
Oct 30, 2026
CompletionEst.
Dec 30, 2026
Last update
Apr 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04851613
Lead sponsor
Laekna Limited
Responsible party
Sponsor
First posted
Apr 20, 2021
Start date
Feb 18, 2022
Primary completion
Oct 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Apr 2, 2026

Study contacts

Wenyue Ma
study director · Laekna Limited

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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Studies of the drug tested here: Afuresertib

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