Purpose of this Study
Before joining the study, adults will be screened, that lasts up to one month. During this time, they will sign a consent form, share their medical history and medicines, have exams, heart tests, lab tests, imaging, and sometimes a tumor biopsy and a test for a gene change called PIK3CA.
If eligible and want to continue, they will join either Cohort 5 or Cohort 6. A computer may choose the group by chance, or they may be placed in a group directly if only one is open. Some groups may require extra biopsies. Each person will sign a new consent for the treatment they are given.
In Cohort 5, people who are pre diabetic may take a medicine like empagliflozin or metformin XR to help manage blood sugar. They will also take inavolisib with fulvestrant, and sometimes palbociclib. The first treatment cycle is a longer, then the rest last 28 days each.
In Cohort 6, each 28 day cycle includes inavolisib taken by mouth once a day, atirmociclib taken by mouth two times a day, and fulvestrant given as a shot.
Who Can Participate?
Eligibility
People can join this study if they are at least 18 years old and have breast cancer that has spread or cannot be removed with surgery. Their cancer must be hormone receptor positive and HER2 negative. They must also have a change in a gene called PIK3CA, which is found through blood or tumor testing.
Participants must be in good enough health to take part. They must be fully active or only limited in hard physical activity. Their blood, liver, and kidneys must work well enough, and their blood sugar must be within the allowed range for their study group. People in Cohort 6 must have lower blood sugar levels, while people in Cohort 5 can have slightly higher levels because it is for pre diabetic patients.
They must also give a tumor sample, either from a recent biopsy or an older saved sample, so doctors can run required tests. They must have cancer that can be measured on imaging scans, or for Cohort 5, cancer that can be measured or evaluated in another way.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study wants to learn how different groups of medicines might help people with advanced breast cancer. The researchers want to see how well the treatments work and what side effects they might cause. By studying these medicine combinations, they hope to find better ways to treat breast cancer in the future.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the
Efficacy And Safety of Multiple Treatment Combinations In Patients with Metastatic
Breast Cancer (Morpheus-Panbc)
Efficacy And Safety of Multiple Treatment Combinations In Patients with Metastatic
Breast Cancer (Morpheus-Panbc)
Principal Investigator
Heather
Moore
Protocol Number
PRO00119527
NCT ID
NCT03424005
Phase
I/II
Enrollment Status
Pending Open to Enrollment