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Antipsychotics

Clinical trials investigating “Antipsychotics” are studying how well these treatments work and how safe they are in specific patient groups. The trial data here focuses on people with locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer who have already had endocrine therapy. These studies measure outcomes such as progression-free survival.

Table of Contents

Trial overview

The provided clinical trial data for Antipsychotics describes one interventional study in people with breast cancer.[1] The study is called “Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With HR+/HER2− Metastatic Breast Cancer Who Have Received Endocrine Therapy.”[1] It is authorised and is designed to compare a study treatment with treatment chosen by the doctor.[1]

Who can join the study

The target group is patients with locally advanced or metastatic breast cancer.[1] The cancer must be hormone receptor-positive (HR-positive) and HER2-negative.[1] The trial also requires that patients have already received an endocrine-based regimen, which means a treatment based on hormones or hormone control.[1]

What is being compared

This is a comparison study, not a simple single-treatment study.[1] The brief summary says the goal is to compare the effect of SG relative to the treatment of physician’s choice on progression-free survival.[1] The intervention list includes multiple possible drugs and routes, showing that the control arm may include several treatment options chosen by the doctor.[1]

Trial phase and size

This study is a Phase 3 trial.[1] Phase 3 studies are usually done in larger groups of patients to compare treatments and confirm how well they work.[1] The planned enrollment is 867 patients, which means the study aims to include 867 people.[1]

Main endpoint and how it is measured

The main endpoint is progression-free survival (PFS).[1] PFS is the time from randomization until the first objective progressive disease or death from any cause, whichever happens first.[1] The trial uses blinded independent central review (BICR) and RECIST v1.1 to assess whether the cancer has grown.[1]

What this means for patients

For patients, this trial is mainly asking whether one treatment approach can keep the cancer from getting worse for longer than the doctor’s chosen treatment.[1] The study is focused on a specific breast cancer group, so not every patient with cancer would fit the trial.[1] Because it is a Phase 3 study, the results are meant to give stronger evidence about treatment benefit in this population.[1]

Trial ID Phase Condition studied Status Enrollment
2022-502593-17-00 Phase 3 Locally advanced or metastatic HR-positive, HER2-negative breast cancer after endocrine therapy Authorised 867

FAQ

  • What are clinical trials of Antipsychotics studying? The trial data provided here studies whether Antipsychotics can improve progression-free survival compared with other treatment choices. It looks at treatment benefit in a specific breast cancer population.
  • Who can take part in these trials? The trial shown is for patients with locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer. Participants must have already received an endocrine-based regimen.
  • What phase is the trial? The trial is a Phase 3 study. Phase 3 trials usually compare treatments in larger groups of patients to see how well they work.
  • What outcome is being measured? The main outcome is progression-free survival, often shortened to PFS. This means the time from randomization until the cancer gets worse or the patient dies from any cause, whichever happens first.
  • Is this trial testing one treatment or comparing treatments? It is comparing Antipsychotics-related study treatment with treatment of physician’s choice. This helps researchers see whether one approach works better than another.

Ongoing Clinical Trials on Antipsychotics

  • Study Comparing Sacituzumab Govitecan with Other Treatments for Patients with HR+/HER2- Metastatic Breast Cancer After Endocrine Therapy

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Greece +5

Glossary

  • Locally advanced cancer: Cancer that has grown outside its original area but has not clearly spread to distant parts of the body.
  • Metastatic cancer: Cancer that has spread to other parts of the body.
  • Hormone receptor-positive (HR-positive): A cancer type that uses hormones to grow.
  • HER2-negative: A cancer type that does not have high levels of the HER2 protein.
  • Endocrine therapy: Treatment that works on hormones or hormone signals.
  • Interventional study: A trial where researchers give a treatment and then measure what happens.
  • Phase 3: A later-stage trial with more patients, used to compare treatments and confirm how well they work.
  • Randomization: A process that assigns patients to a treatment group by chance.
  • Progression-free survival (PFS): The length of time during and after treatment that the cancer does not get worse.
  • Objective progressive disease: Clear signs, seen on tests or scans, that the cancer has grown or spread.
  • Blinded independent central review (BICR): A review of scan results by independent experts who do not know which treatment a patient received.
  • RECIST v1.1: A standard way to measure whether a tumor is shrinking, staying stable, or growing.

References

  1. https://clinicaltrials.gov/study/2022-502593-17-00