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Study of Camizestrant in Patients with ER+/HER2- Early Breast Cancer

This is a Phase III study to help us improve outcomes of patients with ER+/HER2- early breast cancer with intermediate or high risk for disease recurrence. This study is for patients who have completed definitive locoregional therapy and standard adjuvant endocrine therapy for at least 2 years and up to 5 years without disease recurrence. In this study, we want to learn if a new oral "SERD" therapy called Camizestrant is helpful in reducing chance of recurrence. Talk to your Medical Oncologist for more information about this trial.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

You will meet with a member of the study team at each visit. Your study doctor will closely monitor your health while you are participating in the study. You will be assigned randomly to one of 2 arms of the trial. You have a 50% chance of receiving the study drug (Camizestrant). If you don't receive the study drug, you may remain on your current endocrine therapy. This is not a "blinded study." You and your doctor will know which treatment you are on. During the study, you will have several EKG's, ophthalmology visits, vital signs, and blood tests. You will not pay for any of the study procedures, including the study drug or your usual hormonal therapy.

Incentives

Mileage reimbursement from your home address if more than 25 miles from the study clinic. Study medication and study procedures at no cost.

In-person visits:
approximately 17
Phone or online visits:
approximately 10
Total length of participation:
5 years

Looking for Specific Volunteers

Able to participate:

  • Pre-, peri-, and post-menopausal women, and men, who are 18 years or older
  • You have a confirmed history of ER+/HER2- early stage resected invasive breast cancer without evidence of advanced disease.
  • You have undergone surgery with or without radiotherapy for your primary breast cancer.
  • You have completed 2 to 5 years of endocrine therapy, and are still receiving endocrine therapy as part of your treatment.

Not eligible if:

  • You have advanced breast cancer or distant metastatic disease
  • You have a history of certain other cancers unless in complete remission for a minimum of 5 years.
  • You have a previous history of certain breast cancers (Contact the study team for more information)
  • Any cardiac issues or symptoms
  • You are using reproductive hormone therapy

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Rex Cancer Center
2901 Blue Ridge Rd, Raleigh, NC 27607, USA

Additional Study Information

Principal Investigator

Jayadev Manikkam Umakanthan
UNC Hospitals - Rex

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)

IRB Number

23-0429

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