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New treatment option 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 medicine, given as an once-daily, being studied as a potential treatment for breast cancer.
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
- This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
- 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's taking place
- Hot Springs, Arkansas, United States
- Beverly Hills, California, United States
- La Jolla, California, United States
- Los Alamitos, California, United States
- San Francisco, California, United States
- Santa Barbara, 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
- Ames, Iowa, United States
- Scarborough, Maine, United States
- Annapolis, Maryland, United States
- Minneapolis, Minnesota, United States
- Jackson, Mississippi, United States
- Kansas City, Missouri, United States
+ 133 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 - 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?
Study sites include Hot Springs, Arkansas, United States; Beverly Hills, California, United States; La Jolla, California, United States; Los Alamitos, California, United States; San Francisco, California, United States; Santa Barbara, California, United States and 147 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.