Purpose of this Study
We are doing this study to find out if the combination of two hormonal drugs, giredestrant and fulvestrant, are a safe and effective option if they are given with the study doctor's choice of a class of medicines called CDK4/6 inhibitors to people who have ER-positive, HER2-negative breast cancer that is resistant to standard treatments.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with locally advance or metastatic adenocarcinoma of the breast that does not respond to standard therapies</li>
<li>Have a documented estrogen receptor positive (ER+) and HER2 negative (HER2-) tumor</li></ul>
For more information about who can join this study, contact the study team at <a href= "mailto: kylee.ott@duke.edu">kylee.ott@duke.edu.</a>
<li>Are diagnosed with locally advance or metastatic adenocarcinoma of the breast that does not respond to standard therapies</li>
<li>Have a documented estrogen receptor positive (ER+) and HER2 negative (HER2-) tumor</li></ul>
For more information about who can join this study, contact the study team at <a href= "mailto: kylee.ott@duke.edu">kylee.ott@duke.edu.</a>
What is Involved?
This study has three parts:<ul>
<li>1) Screening (to determine if you are eligible for the study) - amongst other procedures, we will test your blood for mutations in ESR1, the gene for the estrogen receptor</li>
<li>2) Study drug period</li>
<li>3) Follow-up (to check on you after the study drug regimen is finished)</li></ul>
You will be assigned to one of the following study groups, with your assigned regimen given in drug cycles that last 4 weeks:<ul>
<li>Group 1 will receive giredestrant (as a pill taken every day) and the study doctor's choice of a CDK4/6 inhibitor between palbociclib or ribociclib (for both, tablets taken once a day for 3 weeks followed by 1 week off treatment), or abemaciclib (tablets taken twice a day continuously)</li>
<li>Group 2 will receive fulvestrant, given as an injection twice in the first cycle and once at the start of every 4-week cycle after that, and the study doctor's choice of a CDK4/6 inhibitor between palbociclib or ribociclib (for both, tablets taken once a day for 3 weeks followed by 1 week off treatment), or abemaciclib (tablets taken twice a day continuously)</li></ul>
Women who have not completed menopause and men will also receive a hormonal suppression medicine known as an LHRH agonist as part of their study treatment.
The group to which you are assigned will be determined by random chance (like tossing a coin). You will have an equal chance of being placed in either group. Your study doctor will discuss with you and decide which CDK4/6 inhibitor you will take for the duration of the study treatment.
<li>1) Screening (to determine if you are eligible for the study) - amongst other procedures, we will test your blood for mutations in ESR1, the gene for the estrogen receptor</li>
<li>2) Study drug period</li>
<li>3) Follow-up (to check on you after the study drug regimen is finished)</li></ul>
You will be assigned to one of the following study groups, with your assigned regimen given in drug cycles that last 4 weeks:<ul>
<li>Group 1 will receive giredestrant (as a pill taken every day) and the study doctor's choice of a CDK4/6 inhibitor between palbociclib or ribociclib (for both, tablets taken once a day for 3 weeks followed by 1 week off treatment), or abemaciclib (tablets taken twice a day continuously)</li>
<li>Group 2 will receive fulvestrant, given as an injection twice in the first cycle and once at the start of every 4-week cycle after that, and the study doctor's choice of a CDK4/6 inhibitor between palbociclib or ribociclib (for both, tablets taken once a day for 3 weeks followed by 1 week off treatment), or abemaciclib (tablets taken twice a day continuously)</li></ul>
Women who have not completed menopause and men will also receive a hormonal suppression medicine known as an LHRH agonist as part of their study treatment.
The group to which you are assigned will be determined by random chance (like tossing a coin). You will have an equal chance of being placed in either group. Your study doctor will discuss with you and decide which CDK4/6 inhibitor you will take for the duration of the study treatment.
Study Details
Full Title
A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING EFFICACY AND SAFETY OF GIREDESTRANT COMPARED WITH FULVESTRANT, BOTH COMBINED WITH A CDK4/6 INHIBITOR, IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WITH RESISTANCE TO PRIOR ADJUVANT ENDOCRINE THERAPY
Principal Investigator
Stacy
Telloni
Protocol Number
PRO00114510
NCT ID
NCT06065748
Phase
III
Enrollment Status
Pending Open to Enrollment