Study on Palazestrant and Ribociclib for First-time Treatment of ER+/HER2- Advanced Breast Cancer
Sponsor: Olema Pharmaceuticals, Inc.
ClinicalTrials ID:NCT07085767
This clinical trial is testing a new combination of drugs, palazestrant and ribociclib, to see if they are more effective and safe compared to the standard treatment of letrozole and ribociclib for people with advanced breast cancer who have not had previous treatment.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to compare the effectiveness and safety of a new drug combination, palazestrant and ribociclib, against the standard treatment of letrozole and ribociclib in adults with ER+/HER2- advanced breast cancer. This trial is for those who have not received any prior systemic treatment for their advanced cancer. About 1,000 participants will be randomly assigned to receive either the new combination or the standard treatment.
Description
This international study involves multiple centers and is designed to test whether the combination of palazestrant and ribociclib is better than the current standard treatment of letrozole and ribociclib for advanced breast cancer. Participants will be randomly divided into two groups: one group will receive palazestrant and ribociclib, while the other group will receive letrozole and ribociclib. The study aims to see which combination works better in controlling the cancer and is safer for patients. Participants will be closely monitored throughout the study to assess the effectiveness and any side effects of the treatments.
Eligibility Criteria
Inclusion Criteria
- Adults of any gender with ER+, HER2- advanced breast cancer that cannot be cured with surgery.
- Cancer must be measurable by scans or be present in the bones only.
- Cancer that is newly diagnosed or has returned after more than a year since finishing hormone therapy.
- Must be in good general health, able to carry out normal activities with minimal restrictions.
- Must have good blood, liver, and kidney function.
- Women can be at any stage of menopause.
- Men and women who are not postmenopausal must agree to take hormone therapy to suppress ovarian function.
Exclusion Criteria
- Cancer returned while on hormone therapy.
- Have received any previous treatment for advanced ER+, HER2- breast cancer.
- Have been treated with certain hormone therapies like fulvestrant or elacestrant before.
- Have allergies to the study drugs.
- Have any medical reasons that prevent the use of letrozole and ribociclib.
- Have cancer that has spread to the brain or spinal cord and needs immediate treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Clinical Trial Site | 50010 | Ames | Iowa |
| Clinical Trial Site | 04074 | Scarborough | Maine |
| Clinical Trial Site | 64132 | Kansas City | Missouri |
| Clinical Trial Site | 87505 | Santa Fe | New Mexico |
| Clinical Trial Site | 18840 | Sayre | Pennsylvania |
| Clinical Trial Site | 37203 | Tennessee City | Tennessee |
| Clinical Trial Site | 84106 | Salt Lake City | Utah |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.