Trial NCT07085767
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
- Phase
- Phase 3
- Sponsor
- Olema Pharmaceuticals, Inc.
- Conditions
- Breast Cancer; Locally Advanced Breast Cancer; Metastatic Breast Cancer; ER Positive Breast Cancer; HER2 Negative Breast Carcinoma
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Performance status
* 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.Brain metastases
Restrictions found (2)
- Brain metastasesConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text
Recruiting in Massachusetts
- Clinical Trial Site · Burlington, Middlesex County