No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,000 (estimated)
Sponsor
Olema Pharmaceuticals, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with advanced breast cancer that hasn’t been treated before. Participants will receive palazestrant with ribociclib or letrozole with ribociclib to see which treatment works better.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult.
I have advanced breast cancer that cannot be cured.
I have measurable disease that can be evaluated.
I have advanced breast cancer that is new or returned after 12 months.
My performance status is 0 or 1.
I have adequate blood, liver, and kidney function.
I am a pre-, peri-, or postmenopausal female.
I am willing to take a GnRH (or LHRH) agonist if I am male or a pre- or peri-menopausal female.
You may not be able to join if
I had a recurrence of my disease during adjuvant therapy.
I am currently receiving or have previously received treatment for advanced breast cancer.
I have received treatments with fulvestrant, elacestrant, or investigational endocrine therapy.
I have a history of allergic reactions to the study treatment.
I have any allergies to letrozole or ribociclib.
I have symptomatic central nervous system metastases or conditions requiring immediate treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion 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 occu…
Inclusion 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.
Exclusion Criteria:
* 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.
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