Open

Study of Camizestrant in ER Positive, HER2 Negative, Early-Stage High Risk Breast Cancer.

In this study, we are trying to find out if a new drug called Camizestrant can improve outcomes and prevent cancer from returning compared to the standard treatment for patients who have completed surgery for ER positive, HER2 negative early-stage, breast cancer.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

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

Location

North Carolina (Statewide)

What will be asked of you

At each visit you will meet with your doctor and your research nurse and have your vital signs measured. At some visits you will have blood draws. Some blood draws are optional. During the study will have several eye exams, EKG's, and will complete questionnaires. At the beginning of the study you will have a CT scan, mammogram, and a bone scan to make sure you don't have any detectable cancer in your body prior to starting on the study. You will take one pill of either camizestrant or standard of care endocrine therapy a day for 7 years.

In-person visits:
17

Phone or online visits:
up to 10

Total length of participation:
7 years on treatment. 5-10 years of annual follow up.

Looking for Specific Volunteers

Able to participate:

you have ER+/HER2- early-stage breast cancer with intermediate-high or high risk of recurrence, and have completed surgery with no evidence of disease.
Have been advised by your physician to start hormonal or endocrine therapy to decrease the chance of recurrence.
You are willing to undergo blood draws, scans, eye exams, and EKGs.

Not eligible if:

Have inoperable or locally advanced breast cancer with or without distant metastasis.
Have certain cardiac symptoms or conditions.

Contact the Team

Visit Location

Contact & Visit Location

Additional Study Information

Principal Investigator

Jayadev Manikkam Umakanthan
UNC Hospitals - Rex

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)

IRB Number

23-2669

Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH. This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

Helpful Links

Questions?

This email address is being protected from spambots. You need JavaScript enabled to view it.