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OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

NCT06016738

Active Not RecruitingPhase 3

Sponsor: Olema Pharmaceuticals, Inc.

Conditions: Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma

Interventions: Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key 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 or bone-only disease).
* Previously received a CDK4/6 inhibitor in combination with an endocrine therapy in the advanced setting. One additional line of ET as a monotherapy is allowed. Duration of the most recent prior ET must be at least 6 months.
* 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.

Key exclusion criteria:

* Symptomatic visceral disease, imminent organ failure, or any other reason that makes the participant ineligible for endocrine monotherapy.
* Previously received chemotherapy in the advanced/metastatic setting.
* Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy.
* History of allergic reactions to study treatment.
* Any contraindications to the selected standard-of-care endocrine therapy in the local prescribing information.
* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
* Clinically significant comorbidities such as significant cardiac or cerebrovascular disease, gastrointestinal disorders that could affect absorption of study treatment.
Locations (233)
  • Tucson, Arizona, United States
  • Fountain Valley, California, United States
  • Glendale, California, United States
  • La Jolla, California, United States
  • Los Alamitos, California, United States
  • Los Angeles, California, United States
  • Whittier, California, United States
  • Aurora, Colorado, United States
  • Denver, Colorado, United States
  • Golden, Colorado, United States
  • Grand Junction, Colorado, United States
  • Danbury, Connecticut, United States
  • Newark, Delaware, United States
  • Jacksonville, Florida, United States
  • Margate, Florida, United States
  • Orlando, Florida, United States
  • Plantation, Florida, United States
  • Tamarac, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Urbana, Illinois, United States
  • Baton Rouge, Louisiana, United States
  • New Orleans, Louisiana, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Saint Louis Park, Minnesota, United States
  • Woodbury, Minnesota, United States
  • Lincoln, Nebraska, United States
  • + 203 more on CT.gov