Ovarian Suppression Therapy for Breast Cancer
(OVELIA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests TOL2506, a treatment that stops ovaries from working, in premenopausal women and men with hormone-sensitive breast cancer. It aims to reduce hormone levels to slow down or stop cancer growth. TOL2506 is a treatment that stops ovaries from working, similar to other ovarian suppression methods.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop all current medications, but it does mention that you cannot use certain hormonal therapies, anticancer medications, or drugs that affect bone density or the QT/QTc interval. It's best to discuss your current medications with the trial team to see if any need to be stopped.
Is ovarian suppression therapy with leuprolide acetate generally safe for humans?
How is the drug TOL2506 different from other treatments for breast cancer?
TOL2506, also known as leuprolide acetate, is unique because it is a gonadotropin-releasing hormone analogue that works by suppressing ovarian function, which can be beneficial in hormone-sensitive breast cancer. Unlike traditional chemotherapy, it is administered as a depot injection, which means it is given less frequently and can be more convenient for patients.36789
What data supports the effectiveness of the drug TOL2506 for breast cancer?
Who Is on the Research Team?
E P Hamilton
Principal Investigator
SCRI Development Innovations, LLC
Are You a Good Fit for This Trial?
This trial is for premenopausal women aged 18-49 with HR+, HER2-negative breast cancer who are candidates for endocrine therapy and ovarian suppression. Men with the same cancer type may also participate. Participants must have normal liver, kidney function, and not be on certain medications or treatments that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TOL2506 in combination with endocrine therapy for ovarian suppression
Follow-up
Participants are monitored for safety and effectiveness after treatment
Safety Extension
Participants may be eligible to participate in a Safety Extension Study under a separate protocol
What Are the Treatments Tested in This Trial?
Interventions
- TOL2506
TOL2506 is already approved in United States, European Union for the following indications:
- Advanced prostate cancer
- Central precocious puberty
- Endometriosis
- Anemia caused by uterine fibroids
- Prostate cancer
- Precocious puberty
- Endometriosis
- Uterine fibroids
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tolmar Inc.
Lead Sponsor