Clinical trial for Breast Cancer
Official title Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
ClinicalTrials.gov ID: NCT07085767
What this study is testing
What is Palazestrant?
Palazestrant is an investigational oral medicine being studied as a potential treatment for advanced ER+, HER2- breast cancer. Palazestrant is designed to bind to and degrade estrogen receptors, reducing estrogen-driven tumor growth.
Also referred to as OP-1250.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether palazestrant with ribociclib works as well as, or better than, letrozole with ribociclib, and to compare safety of the two combos.
- Who it's for
- Adults (women or men) with advanced ER‑positive, HER2‑negative breast cancer who have not received any prior systemic cancer therapy.
- What's involved
- Participants will be given either palazestrant plus ribociclib or letrozole plus ribociclib and will attend regular clinic visits for medication, blood work, imaging and other safety checks.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult female or male participants.
- ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
- Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).
- De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
You likely can't join if
- Disease recurrence during adjuvant endocrine therapy
- Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.
- Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.
- History of allergic reactions to study treatment.
- Any contraindications to letrozole and ribociclib.
- Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate...
See the full eligibility criteria
- Adult female or male participants.
- ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
- Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).
- De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic, hepatic, and renal functions.
- Female participants can be pre-, peri- or postmenopausal.
- Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.
- Disease recurrence during adjuvant endocrine therapy
- Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.
- Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.
- History of allergic reactions to study treatment.
- Any contraindications to letrozole and ribociclib.
- Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
The study team makes the final eligibility decision.
Where it is enrolling
- Hot Springs, Arkansas, United States
- Beverly Hills, California, United States
- La Jolla, California, United States
- Los Alamitos, California, United States
- Oakland, California, United States
- Roseville, California, United States
- San Francisco, California, United States
- Santa Barbara, California, United States
- Santa Clara, California, United States
- Vallejo, California, United States
- Walnut Creek, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Tampa, Florida, United States
- Marietta, Georgia, United States
- Honolulu, Hawaii, United States
- Peoria, Illinois, United States
- Urbana, Illinois, United States
- Scarborough, Maine, United States
+ 159 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hot Springs, Arkansas, United States; Beverly Hills, California, United States; La Jolla, California, United States; Los Alamitos, California, United States; Oakland, California, United States; Roseville, California, United States and 173 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.