Study on Camizestrant for Treating Early ER+/HER2- Breast Cancer After Surgery

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05952557

Provider View

This clinical trial is testing whether the drug camizestrant can improve outcomes for patients with early-stage ER+/HER2- breast cancer who are at intermediate to high risk of the cancer returning after surgery. The study compares camizestrant to standard hormone therapy over a 7-year treatment period.

Patient Parameters

Program Overview

The purpose of this study is to find out if camizestrant, a new hormone therapy, can help prevent the return of early-stage ER+/HER2- breast cancer in patients who have already had surgery and possibly chemotherapy. The study will compare camizestrant to the usual hormone treatments given after surgery. Participants will be treated for 7 years and followed for a total of 10 years to monitor their health and cancer status.

Description

This study is designed to see if camizestrant can improve the chances of staying cancer-free compared to standard hormone therapy in patients with early-stage ER+/HER2- breast cancer. Participants must have completed surgery and possibly chemotherapy for their breast cancer and be at intermediate to high risk of the cancer coming back. The study will last for 7 years, with follow-up for 10 years. Patients may also take another drug called abemaciclib during the study. The main goal is to see how long patients remain free from invasive breast cancer, with other goals including overall survival and safety assessments.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 or older.
  • Diagnosed with early-stage ER+/HER2- breast cancer that has been surgically removed and has not spread to other parts of the body.
  • Completed surgery and possibly radiation for the breast cancer, with or without chemotherapy.
  • Must join the study within 12 months of breast surgery.
  • May have started hormone therapy up to 12 weeks before joining the study.
  • Must be in good general health with an ECOG performance status of 0 or 1.
  • Must have healthy organ and bone marrow function.

Exclusion Criteria

  • Breast cancer that cannot be surgically removed or has spread to other parts of the body.
  • Complete response to pre-surgery treatment, meaning no cancer was found after treatment.
  • History of other cancers unless they are very low risk or have been in complete remission for at least 5 years.
  • Severe or uncontrolled health conditions that would make participating in the study unsafe.
  • Heart problems with a known low ejection fraction or heart failure.
  • Abnormal heart rhythm as shown by a long QT interval on an ECG.
  • Taking hormone therapy for non-cancer conditions.
  • Receiving other cancer treatments not allowed by the study, except for certain bone-strengthening drugs.
  • Previous treatment with camizestrant or similar drugs.
  • Pregnant or breastfeeding women.
  • Allergies to camizestrant or similar drugs, or to LHRH agonists in certain patients.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.