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2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE

Clinical trials are investigating 2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE in people with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This article explains what the trial is trying to measure, who may join, and the phase and main outcome being studied.

Table of contents

Trial overview

This study is testing 2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE in people with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.[1] The trial is designed to see whether the study treatment works better than the comparison treatment after a previous line of therapy has stopped working.[1]

Who the trial is for

The target population is people with advanced or metastatic breast cancer that is hormone receptor-positive and HER2-negative.[1] The study also focuses on patients whose disease has progressed after prior treatment, which means the cancer has gotten worse despite earlier therapy.[1]

What the study compares

The brief summary says the study aims to show the superiority of 2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE plus fulvestrant over ICT, which is the comparator treatment arm in this trial.[1] The listed treatments include fulvestrant, everolimus, and exemestane, showing that the study includes treatment combinations used in different arms.[1]

Trial phase and size

This is a Phase 3 trial, which usually means a larger study that compares treatments in many participants to learn how well they work.[1] The planned enrollment is 400 people, so the study is designed to include a fairly large patient group.[1] The study status is Authorised.[1]

Main endpoint

The main endpoint is progression-free survival (PFS), which is the time from randomization until the cancer first gets worse or the person dies from any cause, whichever happens first.[1] The study measures this using blinded independent central review (BICR) and RECIST v1.1, which are standard ways to assess tumor changes in a fair and consistent way.[1]

What the results will show

If the trial shows better PFS for 2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE plus fulvestrant, it would suggest that this treatment combination may help delay cancer growth longer than the comparison treatment.[1] Because this is a Phase 3 study, the results are meant to give stronger evidence about how the treatment performs in the target patient group.[1]

Trial ID Phase Condition studied Status Enrollment
2025-520566-22-00 Phase 3 Hormone receptor-positive, HER2-negative advanced/metastatic breast cancer Authorised 400

FAQ

  • What is being studied in the clinical trial? The trial is studying 2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE in combination with fulvestrant. It compares this approach with other treatment options in people whose cancer has progressed after a prior line of treatment.
  • Who can take part in the trial? The target group is people with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. The trial is for patients whose disease has gotten worse after a previous treatment.
  • What phase is this trial? This is a Phase 3 trial. Phase 3 studies usually compare treatments in larger groups of people to see how well they work and to confirm earlier findings.
  • What is the main goal of the study? The main goal is to see whether 2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE plus fulvestrant works better than the comparator treatment for progression-free survival. Progression-free survival means the length of time before the cancer gets worse or the person dies.
  • How many people are planned for this study? The planned enrollment is 400 people. That means about 400 participants are expected to join the study.

Ongoing Clinical Trials on 2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE

  • Study of PF-07248144 and fulvestrant in adults with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer who had progression after CDK4/6 inhibitor therapy

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia Finland France Germany +8

  • Prifetrastat (PF-07248144) Plus Fulvestrant in Adults With Advanced HR+/HER2- Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitor Treatment

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Advanced breast cancer: Breast cancer that has grown beyond the breast and nearby lymph nodes or is harder to treat because it has spread.
  • Metastatic breast cancer: Breast cancer that has spread to other parts of the body.
  • Hormone receptor-positive: A cancer that uses hormones, such as estrogen or progesterone, to help it grow.
  • HER2-negative: A cancer that does not have high levels of the HER2 protein.
  • Phase 3: A later stage of clinical testing with larger groups of people, used to compare treatments and measure how well they work.
  • Interventional study: A study where participants receive a treatment or treatment plan that researchers are testing.
  • Randomization: A method that assigns participants by chance to different treatment groups.
  • Progression-free survival (PFS): The time during and after treatment when the cancer does not get worse.
  • Blinded independent central review (BICR): A review of scans or results by independent experts who do not know which treatment the person received.
  • RECIST v1.1: A standard way to measure whether a tumor has shrunk, stayed the same, or grown.

References

  1. https://clinicaltrials.gov/study/2025-520566-22-00