Study on Camizestrant for ER+/HER2- Early Breast Cancer After 2 Years of Standard Hormone Therapy

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05774951

Provider View

This clinical trial is testing whether the drug camizestrant can improve outcomes for patients with ER+/HER2- early breast cancer who have already completed at least 2 years of standard hormone therapy. The study will compare camizestrant to the usual hormone treatments over a period of 5 years.

Patient Parameters

Program Overview

The purpose of this study is to find out if camizestrant can provide better results than standard hormone therapy for patients with ER+/HER2- early breast cancer who are at intermediate or high risk of the cancer coming back. Participants must have completed surgery and at least 2 years of hormone therapy. The study will last for 5 years, and patients will be monitored for 10 years to see how well they do.

Description

This study is looking at whether camizestrant can improve outcomes for patients with ER+/HER2- early breast cancer who have already had surgery and at least 2 years of hormone therapy. The study will last for 5 years, and patients will be monitored for 10 years. Participants must be at intermediate or high risk of the cancer returning. The study will measure how long patients remain free of invasive breast cancer and other outcomes like overall survival and safety. Patients who have used CDK4/6 inhibitors before can participate. The study will follow patients for 10 years after the last patient joins.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 or older.
  • Diagnosed with ER+/HER2- early-stage breast cancer that has been surgically removed and is at intermediate or high risk of coming back.
  • Completed surgery and possibly radiation for the primary breast tumor, with or without chemotherapy.
  • Finished at least 2 years but no more than 5 years of hormone therapy, possibly with a CDK4/6 inhibitor.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ and bone marrow function.

Exclusion Criteria

  • Have breast cancer that cannot be operated on or has spread to other parts of the body.
  • Achieved complete response after pre-surgery therapy.
  • Have had another cancer in the past 5 years, except for certain skin cancers or very low-risk cancers.
  • Have severe or uncontrolled diseases that would prevent participation.
  • Have heart problems with a known ejection fraction below 50% or heart failure of grade 2 or higher.
  • Have a prolonged QT interval on an ECG (QTcF greater than 480 milliseconds).
  • Are using hormone therapy for non-cancer conditions.
  • Are receiving any other cancer treatment not specified in the study, except for certain bone-strengthening drugs.
  • Have previously been treated with camizestrant or similar drugs.
  • Are pregnant or breastfeeding.
  • Have allergies to camizestrant or similar drugs, or to LHRH agonists if pre-/peri-menopausal or male.

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