We’re challenging the status quo so those who live with metastatic breast cancer have the potential to feel better, longer.

We know that from the moment of diagnosis, lives are forever changed. Much progress has been made within the breast cancer treatment space. But it is not enough.

At Olema, we are inspired by people and their stories and are determined to develop safer, more effective and convenient medicines to signal in a new day for those impacted by metastatic breast cancer.

Breast cancer overview

We show up to work every day because we’re driven to impact millions of lives, helping not only people with breast cancer, but their families, caregivers, and communities.

With our lead investigational product candidate, palazestrant (OP-1250), we seek to address estrogen receptor-positive (ER+) breast cancer, which represents about 80% of all breast cancer cases. Palazestrant is a once-daily oral medicine designed to provide a more convenient and potentially more effective approach for managing ER+/HER2- breast cancer that has recurred or spread beyond the initial disease site.

  • Breast cancer is the second most prevalent cancer worldwide, with nearly 2 million new diagnoses each year. In 2024, the American Cancer Society estimates that there will be approximately 310,720 new cases of female breast cancer and about 42,250 deaths from metastatic breast cancer in the United States.
  • Approximately 6 to 10% of breast cancer patients present with metastatic disease at diagnosis and a further 20 to 30% of patients initially diagnosed with early-stage disease ultimately develop metastatic disease.
  • The current five-year survival rate for patients with ER+ metastatic breast cancer is approximately 30%.

Current clinical trials

Before a new therapy can be made available to the general public, multiple studies involving patient volunteers must be conducted to evaluate the safety and effectiveness of the therapy.

These studies, referred to as clinical trials, are regulated by the Food and Drug Administration (FDA) in the United States and by similar regulatory agencies worldwide.

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/​HER2- Advanced Breast Cancer (OPERA-01)

Please visit OPERA01study.com for more information about participation in the trial.
Learn more about OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/​HER2- Advanced Breast Cancer (OPERA-01)

A Phase 1b Study in Combination With a CDK4/6 Inhibitor or With a PI3K Inhibitor

Learn more about A Phase 1b Study in Combination With a CDK4/6 Inhibitor or With a PI3K Inhibitor

A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer

Hormone Receptor Positive Breast Carcinoma | HER2-negative Breast Cancer
Learn more about A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer

A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

Learn more about A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients