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Hormone Therapy

OP-1250 for Advanced Breast Cancer (OPERA-01 Trial)

Phase 3
Recruiting
Research Sponsored by Olema Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evaluable disease (measurable disease or bone-only disease)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until death due to any cause (estimated as up to 4 years)
Awards & highlights

OPERA-01 Trial Summary

This trial compares the safety and effectiveness of a new drug for advanced breast cancer to existing treatments.

Who is the study for?
This trial is for adults with ER+/HER2- advanced breast cancer that's progressed after endocrine therapy and a CDK4/6 inhibitor. Participants need to be in good physical condition (ECOG 0 or 1), have proper organ function, and if male or pre-menopausal female, agree to take hormone-blocking injections.Check my eligibility
What is being tested?
The study compares OP-1250, a new treatment option, against standard treatments like fulvestrant or aromatase inhibitors (Anastrozole, Letrozole, Exemestane) in patients whose breast cancer has worsened despite previous therapies.See study design
What are the potential side effects?
Potential side effects may include reactions related to hormone changes due to the treatments such as hot flashes and mood swings. There could also be injection site reactions from GnRH agonists for some participants.

OPERA-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured or is only in my bones.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My breast cancer is ER positive, HER2 negative, advanced, and cannot be cured with surgery or radiation.
Select...
I am willing to take hormone therapy if I am a man or a woman who has not gone through menopause.

OPERA-01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until death due to any cause (estimated as up to 4 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until death due to any cause (estimated as up to 4 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-Selection Part: Incidence of adverse events
Dose-Selection Part: Incidence of dose reduction
Dose-Selection Part: Incidence of drug discontinuation
+1 more
Secondary outcome measures
Trial: Overall Survival (OS)

OPERA-01 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Palazestrant (OP-1250)Experimental Treatment1 Intervention
Participants will receive Palazestrant
Group II: Standard of Care Endocrine TherapyActive Control4 Interventions
Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)

Find a Location

Who is running the clinical trial?

Olema Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
273 Total Patients Enrolled
1 Trials studying Breast Cancer
30 Patients Enrolled for Breast Cancer
Medical Director, MDStudy DirectorOlema Pharmaceuticals, Inc.
77 Previous Clinical Trials
15,906 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being welcomed to join this research?

"Affirmative. Data available on clinicaltrials.gov confirms that this health investigation, initially posted on October 10th 2023, is actively looking for participants. Approximately 510 individuals must be enrolled across 5 medical sites."

Answered by AI

How many medical facilities are currently participating in this trial?

"This clinical trial is presently taking in patients at 5 different sites, located in Port Jefferson Station, Adelaide and Clayton among other cities. It's wise to choose the closest site possible to minimize travel if you decide to take part."

Answered by AI

Are there any known hazards associated with the use of OP-1250 (palazestrant) in patients?

"Through our risk-assessment study, OP-1250 (palazestrant) earned a rating of 3. This is based on the fact that this pharmaceutical has been tested in Phase 3 trials and there are multiple rounds of data supporting its safety profile."

Answered by AI

Is the recruitment period for this trial still ongoing?

"Clinicaltrials.gov indicates that this study is currently seeking participants, which has been noted since its initial posting on October 10th 2023 and most recently updated November 10th 23."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Trial Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
2023. "OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06016738.
All > Spokane
~340 spots leftby Jun 2026
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