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

Recruiting in Palo Alto (17 mi)

+151 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Olema Pharmaceuticals, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called palazestrant to see if it works better than current treatments for adults with advanced breast cancer that has not responded to previous therapies. The drug aims to stop cancer growth by blocking estrogen.

Eligibility Criteria

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.

Inclusion Criteria

I am an adult.

My cancer can be measured or is only in my bones.

I've been treated with a CDK4/6 inhibitor and hormone therapy for advanced cancer.

+5 more

Exclusion Criteria

My cancer is causing symptoms or organ failure, making me ineligible for hormone therapy.

I need urgent treatment for cancer spread to my brain or spinal cord.

I have no major health issues that could affect my treatment.

+4 more

Participant Groups

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.

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)

Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Arimidex for:

Breast cancer
Early breast cancer in postmenopausal women

🇺🇸 Approved in United States as Arimidex for:

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer

🇨🇦 Approved in Canada as Arimidex for:

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer

🇯🇵 Approved in Japan as Arimidex for: