NRG-BR009 OFSET (Breast Cancer) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to compare two commonly used treatment choices for early-stage breast cancer in premenopausal women. We want to know if either option is a better choice than the other.
ER-Positive & HER2-Negative Breast Cancer
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with breast cancer that is ER-positive and HER2-negative
- Are premenopausal (have evidence of functioning ovaries)
For more information about who can join this study, contact the study team at nick.jeffries@duke.edu.
What is Involved?
If you choose to join this study, you will be get a random assignment (like a coin flip) to 1 of 2 groups:
Group 1: If you are in this group, you will get the usual hormonal drugs to treat this type of cancer. You will get a drug as a pill you take by mouth every day. You will continue to receive the hormonal drug daily for at least 5 years unless you develop an allergy or severe side effects to the drug, or your breast cancer returns. You will get an injection of an ovarian suppression drug.
Group 2: If you are in this group, you will get the usual chemotherapy chosen by your doctor to treat this type of cancer. You also will get the usual hormonal drugs to treat this type of cancer. You will get a hormonal drug as a pill you take by mouth every day. You will continue to receive the hormonal drug daily for at least 5 years unless you develop an allergy or severe side effects to the drug, or your breast cancer returns. You will get an injection of an ovarian suppression drug.
Study Details
