Image

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

Trying a new treatment for advanced breast cancer compared to standard care.

Recruiting
18 years and older
All
Phase 3
Study Summary

This study is for people with advanced breast cancer, which means the cancer has spread to other parts of the body. The study tests a new drug, palazestrant (OP-1250), against usual treatments like fulvestrant or aromatase inhibitors (anastrozole, letrozole, exemestane). Aromatase inhibitors are drugs that lower estrogen levels in the body, and fulvestrant blocks estrogen effects. The trial is open-label, so participants know which treatment they receive. To join, participants must have ER+ (estrogen receptor-positive) and HER2- (human epidermal growth factor receptor 2-negative) breast cancer, meaning their cancer grows with estrogen but not with HER2 proteins. Participants should have had prior treatment with CDK4/6 inhibitors, which are drugs that slow cancer cell growth. The study will enroll approximately 510 participants for different parts of the trial.

  • The study lasts until the required number of participants is reached.
  • Participants must visit study centers for evaluations.
  • Potential risks include usual side effects of cancer treatments.
Study details
    Breast Cancer
    Advanced Breast Cancer
    Metastatic Breast Cancer
    ER Positive Breast Cancer
    HER2 Negative Breast Carcinoma

NCT06016738

Olema Pharmaceuticals, Inc.

13 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

  Other languages supported:

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.