Purpose of this Study
We are doing this study to find out if neratinib combined with palbociclib is better than neratinib alone when it comes to treating HER2-positive tumors.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are part of the ComboMATCH Master Registration Trial EAY191</li>
<li>Have a type of solid tumor (not breast cancer) that has too much of a protein called HER2</li>
<li>Have had their disease return after treatment or have disease that did not respond to treatment</li></ul>
For more information about this study, please contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
<li>Are part of the ComboMATCH Master Registration Trial EAY191</li>
<li>Have a type of solid tumor (not breast cancer) that has too much of a protein called HER2</li>
<li>Have had their disease return after treatment or have disease that did not respond to treatment</li></ul>
For more information about this study, please contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will be randomly assigned (like a coin flip) to 1 of 2 groups:
<strong>Group One</strong>
If you are in this group, you will get the study drugs neratinib and palbociclib. You will get neratinib as pills you take by mouth once every day, and palbociclib as pills you take by mouth every day for 21 days, followed by 7 days off.
You will start this study regimen taking neratinib alone. Over the first two weeks of treatment, you will gradually increase the dose you take. On week three, you will start taking the full dose of neratinib and you will also start taking palbociclib on the schedule described above. You will take neratinib and palbociclib for as long you as you and th study doctor believe that your are benefitting.
<strong>Group Two</strong>
If you are in this group, you will get the study drug neratinib. You will get this drug as a pill you take by mouth once every day. Every 28 days of this treatment is called a cycle. Over the first two weeks of treatment, you will gradually increase the dose you take.
<strong>Group One</strong>
If you are in this group, you will get the study drugs neratinib and palbociclib. You will get neratinib as pills you take by mouth once every day, and palbociclib as pills you take by mouth every day for 21 days, followed by 7 days off.
You will start this study regimen taking neratinib alone. Over the first two weeks of treatment, you will gradually increase the dose you take. On week three, you will start taking the full dose of neratinib and you will also start taking palbociclib on the schedule described above. You will take neratinib and palbociclib for as long you as you and th study doctor believe that your are benefitting.
<strong>Group Two</strong>
If you are in this group, you will get the study drug neratinib. You will get this drug as a pill you take by mouth once every day. Every 28 days of this treatment is called a cycle. Over the first two weeks of treatment, you will gradually increase the dose you take.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
EAY191-N5: A Randomized Trial of Neratinib, A Pan-ERBB Inhibitor, Alone or in Combination with Palbociclib, a CDK4/6 Inhibitor, in Patients with HER2+ Gynecologic Cancers and Other Solid Tumors: A ComboMATCH Treatment Trial
Principal Investigator
Angeles
Secord
Protocol Number
PRO00115696
NCT ID
NCT06126276
Phase
II
Enrollment Status
Open to Enrollment