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.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with breast cancer that is ER-positive and HER2-negative</li>
<li>Are premenopausal (have evidence of functioning ovaries)</li></ul>
For more information about who can join this study, contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
<li>Are diagnosed with breast cancer that is ER-positive and HER2-negative</li>
<li>Are premenopausal (have evidence of functioning ovaries)</li></ul>
For more information about who can join this study, contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
Age Range
18-110
Sex/Genders
Female (cisgender)
Looking for Healthy Participants
No
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:
<strong>Group 1:</strong> 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.
<strong>Group 2:</strong> 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.
<strong>Group 1:</strong> 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.
<strong>Group 2:</strong> 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.
Locations
Duke University Hospital
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
NRG-BR009: A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score
Principal Investigator
Alexandra
Thomas
Protocol Number
PRO00115431
NCT ID
NCT05879926
Phase
III
Enrollment Status
Open to Enrollment