OP-1250 for Advanced Breast Cancer

(OPERA-01 Trial)

Recruiting at 151 trial locations

Overseen By Olema Pharmaceuticals, Inc.

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.

Research Team

Medical Director, MD

Principal Investigator

Olema Pharmaceuticals, Inc.

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.

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.

Treatment Details

Interventions

• Anastrozole (Hormone Therapy)
• Exemestane (Hormone Therapy)
• Fulvestrant (Hormone Therapy)
• Letrozole (Hormone Therapy)
• OP-1250 (Palazestrant) (Hormone Therapy)

Trial Overview 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.

Participant Groups

Group I: Palazestrant (OP-1250) Experimental Treatment 1 Intervention

Participants will receive Palazestrant

Group II: Standard of Care Endocrine Therapy Active Control 4 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 Canada, Japan for the following indications:

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:

• Breast cancer

Who Is Running the Clinical Trial?

Olema Pharmaceuticals, Inc.

Lead Sponsor

Trials

5

Recruited

970+