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New treatment option for Breast Cancer
Official title OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
ClinicalTrials.gov ID: NCT06016738
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 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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 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...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
You likely can't join if
- 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...
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 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- 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
+ 185 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 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 and 199 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.