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Anatomic Stage III Breast Cancer AJCC v8Phase 2NCT05967286

Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial

A Phase 2 study testing Alpelisib, Biopsy and Biospecimen Collection in people with Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, run by National Cancer Institute (NCI).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This phase II ComboMATCH treatment trial studies the effect of adding a drug called BYL719 (alpelisib) to the usual treatment of olaparib in patients with breast cancer that has spread from where it first started (breast) to other places in the body (metastatic). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Alpelisib, Biopsy and Biospecimen Collection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
23 Oct 2023to 30 Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-A2 based on the presence of an actionable mutation as defined in EAY191
  • Metastatic or unresectable breast cancer that is HER2-negative (by American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)
  • Patients with estrogen receptor positive (ER+) or ER-negative disease are eligible
  • Germline or deleterious somatic mutation in at least one of: BAP1, BARD1, BRCA1, BRCA2, BRIP1 (FANCJ), FANCA, FANCC, FANCD2, FANCE, FANCF, FANCM, MRE11,PALB2, RAD50, RAD51B, RAD51C, RAD51D
  • COHORTS 1 AND 2 (PARP-INHIBITOR NAIVE): No prior PARP-inhibitor is allowed. Prior mTOR- or AKT-inhibitor is allowed
  • COHORTS 1 AND 2 (PARP-INHIBITOR NAIVE): PIK3CA mutation status
Show all 39Show fewer
  • COHORT 3 (PRIOR PARP-INHIBITOR): Patient must have received and progressed on prior PARP inhibitor therapy in any setting; intervening lines of therapy are allowed
  • At least one measurable lesion that can be accurately assessed at baseline by CT (MRI where CT is contraindicated) and is suitable for repeated assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Prior PI3K inhibitor therapy is allowed
  • Patients with estrogen receptor positive (ER+) disease are eligible after progression on at least 1 prior endocrine treatment in the metastatic setting
  • No treatment within 4 weeks of registration which includes: investigational medicinal product (IMP), systemic anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, targeted therapy except for PI3K inhibitors, biologics, tumor embolization, or monoclonal antibodies). If there is a period needed for the IMP or systemic treatment to be cleared from the body that may take longer than 4 weeks (i.e. period of 5 half lives), the longer time period should be utilized
  • No major surgery done =< 14 days prior to registration, or patients must have recovered from any effects from any major surgery that occurred > 14 days prior to registration
  • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown and an agent that has known genotoxic, mutagenic and teratogenic effects
  • Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status =< 2 (or Karnofsky >= 60%)
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Total Bilirubin =< 1.5 x upper limit of normal (ULN)
  • Except in the event of Gilbert disease, in which case total bilirubin must be =< 2 x ULN
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 × institutional ULN
  • Hemoglobin (Hgb) >= 10.0 g/dL with no blood transfusion in the past 28 days
  • Fasting plasma glucose (FPG) =< 140 mg/dL (7.7 mmol/L)
  • Glomerular filtration rate (GFR) >= 50 mL/min
  • Based on a 24-hour urine test for creatinine clearance or estimated using the Cockcroft-Gault equation
  • Patients must be able to swallow oral formulations of the agents and must not have gastrointestinal disorders likely to interfere with absorption of the study medication
  • Patients must not have symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression are excluded unless considered to have received definitive treatment for this and evidence of clinically stable
  • Patients with known myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML should be excluded
  • Patients who have had previous organ transplant, allogeneic bone marrow transplant or double umbilical cord blood transplantation should be excluded
  • Patients must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patients with type 1 diabetes mellitus are not eligible. Those with controlled type 2 diabetes mellitus (T2DM) are eligible. Patients with controlled T2DM, including those on insulin treatment, must meet the fasting plasma glucose requirement
  • Patients must not have a known hypersensitivity to olaparib or BYL719 (alpelisib)
  • Patients must not have known active hepatitis (i.e., hepatitis B or C) or human immunodeficiency virus (HIV) with detectable viral load. Patients with a history of HIV with undetectable viral load within 6 months are eligible) as long as drug-drug interactions are safe with study drugs if on anti-retroviral treatment. Testing at baseline for hepatitis or HIV is recommended but not required. If a patient had a history of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated prior to registration. If a patient had a history of hepatitis C virus (HCV) infection, they must have received the appropriate treatment and have an undetectable HCV viral load prior to registration
  • Patients must not have a Grade 2 neuropathy or greater, within 14 days prior to registration
  • Chronic concomitant treatment with strong inhibitors of CYP3A4 (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) is not allowed on this study. Patients on strong or moderate CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
  • Chronic concomitant treatment with strong CYP3A4 inducers (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil) is not allowed. Patients must discontinue 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents prior to registering to the study treatment
  • Cohort Migration EAY191-A2 Eligibility Criteria: Patients treated with Cohort 2 control treatment olaparib who experience disease progression may elect to migrate to Cohort 3 and receive combination treatment with BYL719 (alpelisib) and olaparib. Patients who choose to do so must meet laboratory values and performance status requirements as above and must be begin treatment within 21 days

Who cannot join

None listed.

About this study

Official title: Olaparib Plus Low-Dose Alpelisib for Breast Cancer: A ComboMATCH Treatment Trial

This phase II ComboMATCH treatment trial studies the effect of adding a drug called BYL719 (alpelisib) to the usual treatment of olaparib in patients with breast cancer that has spread from where it first started (breast) to other places in the body (metastatic). Olaparib is an inhibitor of PARP, an enzyme that helps repair DNA when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Alpelisib blocks certain proteins, which may help keep tumor cells from growing and may kill them. It is a type of kinase inhibitor. Giving alpelisib in combination with olaparib may be able to improve treatment results for patients with metastatic breast cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine whether BYL719 (alpelisib) and olaparib combination therapy improves progression-free survival (PFS) compared to olaparib alone in patients with PARP-inhibitor naive metastatic HER2-negative breast cancer. (Cohort 2) II. To determine the ORR of BYL719 (alpelisib) and olaparib in patients with PARP-inhibitor-resistant HER2-negative metastatic breast cancer. (Cohort 3)

SECONDARY OBJECTIVES:

  1. To determine whether BYL719 (alpelisib) and olaparib combination therapy improves objective response rate (ORR), overall survival (OS), clinical benefit rate (CBR), and tolerability compared to olaparib alone in patients with PARP-inhibitor naive metastatic HER2-negative breast cancer. (Cohort 2) II. Collect tissue and provide it to the ComboMATCH Registration Protocol to assess concordance between the diagnostic tumor mutation profile generated by the Designated Laboratories, the pre-treatment biopsy mutation profile, and the pre-treatment circulating tumor deoxyribonucleic acid (ctDNA) mutation profile from plasma, as described in ComboMATCH Registration Protocol. (Cohort 2) III. To assess the clinical activity of BYL719 (alpelisib) and olaparib combination therapy as measured by progression free survival (PFS), overall survival (OS), clinical benefit rate (CBR), and tolerability in patients with PARP-inhibitor-resistant HER2 negative metastatic breast cancer. (Cohort 3) IV. Collect tissue and provide it to the ComboMATCH Registration Protocol to assess concordance between the diagnostic tumor mutation profile generated by the Designated Laboratories, the pre-treatment biopsy mutation profile, and the pre-treatment ctDNA mutation profile from plasma, as described in ComboMATCH Registration Protocol. (Cohort 3)

TRANSLATIONAL OBJECTIVES:

  1. To explore the effect of PIK3CA mutations on ORR and PFS in the study population.

II. To assess correlates of response to olaparib and BYL719 (alpelisib) therapy in the study population including:

IIa. Germline and somatic mutations in DNA repair genes in blood and tumor samples from patients; IIb. DNA and ribonucleic acid (RNA) signatures, loss of heterozygosity (LOH) and other measures of tumor genomic loss and instability from unbiased sequencing of DNA and RNA from patients; IIc. Biomarkers of DNA repair defects or homologous recombination repair deficiency in tumor tissue (e.g. RAD51 nuclear foci); IId. Clinical factors (e.g. prior chemotherapy; estrogen receptor status of tumor).

OUTLINE: Patients are assigned to 1 of 3 cohorts.

COHORT 1: PARP-inhibitor naive patients are assigned to Arm A.

ARM A: Patients receive olaparib orally (PO) twice daily (BID) and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Patients also undergo magnetic resonance imaging (MRI), computed tomography (CT), and/or positron emission tomography (PET) scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

COHORT 2: PARP-inhibitor naive patients are randomized to 1 of 2 arms.

ARM B: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

ARM C: Patients receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients experiencing disease progression have the option to migrate to Cohort 3, Arm D. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

COHORT 3: PARP-inhibitor resistant patients are assigned to Arm D.

ARM D: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

After completion of study treatment, patients are followed every 6 months for up to 5 years from registration.

Being tested
Alpelisib, Biopsy, Biospecimen Collection, Bone Scan, Computed Tomography

What participants receive

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

  • AlpelisibDrug

    Also called BYL719, Phosphoinositide 3-kinase Inhibitor BYL719, Piqray, VIJOICE

    Given PO

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scans

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

    Undergo MRI

  • OlaparibDrug

    Also called AZD 2281, AZD-2281, AZD2281, KU-0059436

    Given PO

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET

Study groups in NCT05967286
Study groupRoleWhat they receive
Cohort 1, Arm A (olaparib, alpelisib)ExperimentalPatients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
Receives: Drug: Alpelisib; Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Magnetic Resonance Imaging; Drug: Olaparib
Cohort 2, Arm B (olaparib, alpelisib)ExperimentalPatients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
Receives: Drug: Alpelisib; Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Olaparib; Procedure: Positron Emission Tomography
Cohort 2, Arm C (olaparib)Active comparatorPatients receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients experiencing disease progression have the option to migrate to Cohort 3, Arm D. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Olaparib
Cohort 3, Arm D (olaparib, alpelisib)ExperimentalPatients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.
Receives: Drug: Alpelisib; Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Olaparib; Procedure: Positron Emission Tomography

What is being measured

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

  1. Progression-free survival (PFS) (Cohort 2)

    Will compare the PFS distributions between those treated with BYL719 (alpelisib) and olaparib versus (vs) olaparib. Despite this being a randomized phase II trial, we will utilize an intent to treat approach such that patients will be analyzed based on the treatment arm to which they were randomized. Will be compared between the two treatment arms using Kaplan-Meier methods. The hazard ratio, median PFS, and estimated PFS rates at 6, 12, 18, 24, and 30 months will be estimated along with corresponding 95% confidence intervals.

    Measured: From randomization date until the time of disease progression or death due to any cause, assessed up to 5 years

  2. Objective response rate (ORR) (Cohort 3)

    Defined as the proportion of patients who documented a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 divided by the total number of evaluable patients in a cohort.

    Measured: Up to 5 years

Secondary outcomes (6)

  1. ORR (Cohort 2)

    RECIST v1.1 criteria will be used to estimate ORR where ORR is defined as the number of evaluable patients achieving a response (PR or CR per RECIST v1.1) during treatment with study therapy divided by the total number of evaluable patients. Rates of response will be compared between treatment arms using a chi-square test (or Fisher's exact test as needed). Point estimates will be generated for objective response rates within each arm along with 95% confidence intervals using the Clopper-Pearson method.

    Measured: Up to 5 years

  2. PFS (Cohort 3)

    Disease progression will be determined based on RECIST 1.1 criteria. PFS will be estimated using the Kaplan-Meier method. The median PFS and corresponding 95% confidence interval will be reported. Patients will be censored at the last disease assessment date if they were alive and progression-free at the time of their last assessment. If a patient begins a non-protocol therapy, the patient will be censored at the last assessment date prior to start of non-protocol therapy.

    Measured: From study entry to the first of either disease progression or death from any cause, assessed up to 5 years

  3. Overall survival (OS) (Cohorts 2 and 3)

    Patients who are alive at last follow-up will be censored at that time point. The distribution of OS will be estimated using method of Kaplan-Meier. The median OS and 95% confidence interval will be reported.

    Measured: From registration until death due to any cause, assessed up to 5 years

  4. Clinical benefit rate (CBR) (Cohorts 2 and 3)

    Defined as achieving CR, PR or stable disease (SD) while on treatment. Disease status will be assessed using RECIST v1.1 criteria. CBR will be calculated as the proportion of evaluable patients who achieve clinical benefit. The final CBR point estimate and corresponding 95% confidence interval will be calculated using Clopper-Pearson method.

    Measured: From registration until death due to any cause, assessed up to 5 years

  5. Incidence of adverse events (Cohorts 2 and 3)

    All eligible patients that have initiated treatment will be considered evaluable for assessing AE rate(s). Patients will be evaluated for adverse events using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the AE(s) to the study treatment will be taken into consideration.

    Measured: Up to 5 years

  6. Concordance of diagnostic tumor mutation profile (Cohorts 2 and 3)

    Concordance of diagnostic tumor mutation profile generated by the Designated Laboratory, the pre-treatment biopsy mutation profile, and the pre-treatment ctDNA mutation profile will be assessed.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start23 Oct 2023 (estimated)
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Why it stopped: Other - Protocol moved to Withdrawn

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05967286
Sponsor's protocol ID
NCI-2023-05623
Other IDs
NCI-2023-05623, EAY191-A2, EAY191-A2, U10CA180821
Status last verified
Mar 2024
First submitted
28 Jul 2023
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alpelisib, Biopsy and Biospecimen Collection in people with Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, run by National Cancer Institute (NCI).

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 39 inclusion and 0 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: withdrawn, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Progression-free survival (PFS) (Cohort 2) (time frame: From randomization date until the time of disease progression or death due to any cause, assessed up to 5 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?

On the ClinicalTrials.gov record for NCT05967286.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.

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