Your session is about to expire
← Back to Search
Ovarian Suppression Therapy for Breast Cancer (OVELIA Trial)
OVELIA Trial Summary
This trial is testing a new drug to suppress ovarian function in premenopausal women with breast cancer. The study will also assess the safety of the drug in men with breast cancer.
OVELIA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowOVELIA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.OVELIA Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I haven't used tamoxifen, SERMs, aromatase inhibitors, mTOR inhibitors, or hormone therapy in the 3 months before my breast cancer diagnosis.I have received hormone therapy for breast cancer since my diagnosis.I haven't taken drugs or supplements for bone density in the last 6 months.I have had a fracture from a fall at standing height or less, excluding fingers, toes, face, and skull, in the last year.I have been on GnRH analogs within a year before my breast cancer diagnosis.My BMI is either below 18 or above 35.Your follicle stimulating hormone (FSH) level is less than 40 IU/L.Your creatinine level is more than three times the upper limit of normal.My liver is severely damaged.My kidney function is not within the normal range.Your heart takes longer than usual to recharge between beats.I cannot have a bone density scan due to surgery, metal in my body, or my weight.I have not taken hormones like estrogen, progesterone, or androgens in the last 30 days.I have not used hormonal contraceptives in the last 30 days.I have regular menstrual cycles or confirmed premenopausal status.Your alkaline phosphatase levels are more than twice the normal limit.Your AST levels in the blood are more than double the normal limit.I haven't taken any medications that affect heart rhythm recently.Your heart beats more than 100 times in a minute.I am sexually active and not planning to use non-hormonal birth control during the study.I need help with my daily activities due to my health condition.My kidney function is reduced and I have low bone density.You are allergic to GnRH, GnRH agonist/analogs, or any of the ingredients in the study medication.Your PR interval on an electrocardiogram is longer than 220 milliseconds.My breast cancer is early to mid-stage, hormone receptor positive, and HER2 negative.You are expected to live for less than 12 months.My kidney function is low, with a creatinine clearance of 30 mL/min or less.You have a history of abnormal heart tests or a recent abnormal heart test.I haven't taken any medication that weakens bones in the last 6 months.I am not on medications that could affect my safety or the study drug's effects.I have not taken any hormonal therapy by mouth or skin patch in the last 30 days.I am between 18 and 49 years old.My liver function is not within normal limits.I have been treated for weak bones or have a low bone density score.Your QRS duration is longer than 120 milliseconds.I am not taking any cancer medications not approved by this study.Your bilirubin levels are more than 2 times the normal limit.I need to check if I meet the male-specific criteria.I am female.I am premenopausal.I am eligible for hormone therapy and have had a specific hormone test within the last month.Your E2 hormone level is higher than 30 pg/mL.Your alanine aminotransferase (ALT) levels are more than twice the normal limit.
- Group 1: Active Comparator: TOL2506
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the therapeutic benefits of TOL2506?
"TOL2506 is most often used to treat cancer, but it can also be helpful for patients with high risk ovarian cancer and tamoxifen."
Who meets the requirements to be a part of this clinical research?
"In order to qualify for this experiment, individuals must have been diagnosed with breast cancer and be between 18-49 years old. A total of 250 individuals are needed for the study."
Does TOL2506 have the go-ahead from the FDA?
"TOL2506 is estimated to be a safe 3 because it is a Phase 3 trial, meaning that not only is there supporting data for efficacy, but also multiple rounds of data affirming its safety."
Does this research have a presence in more than one state?
"The trial is being conducted at 35 sites, which are located in cities such as Glenn Dale, Tyler, Chicago, and others. If you want to participate in the trial, you should try and select a location near you to limit travel."
For what age bracket is this particular trial designed?
"The age range for this particular clinical trial is 18-49. For patients that don't fit this criterion, there are other options: 85 medical studies exist for patients under 18 and 2788 studies are available for patients over the age of 65."
Are there any vacancies in this trial for volunteers?
"That is correct. The information available on clinicaltrials.gov affirms that this study is currently seeking participants. The trial was posted on 7/1/2021 and was last updated on 10/21/2022. The researchers are looking to enroll 250 people across 35 different sites."
What are the expected benefits of participating in this research?
"The primary objective of this clinical study, which will use TOL2506 and will be monitored for approximately 6 weeks after the initial administration, is to assess ovarian function suppression. Additionally, this trial will also measure secondary outcomes such as the percent of subjects with suppressed levels of LH and E2 who also experience amenorrhea when taking TOL2506 + endocrine therapy, and the percent of subjects who experience ovarian function suppression at weeks 12, 24, 36, and 48 when taking TOL2506 + aromatase inhibitor."
What other studies has TOL2506 been a part of in the past?
"TOL2506 was first studied at Queen Mary University of London in 1994. As of now, 434 completed trials have been conducted. There are 234 active studies, with a significant number of these taking place in Glenn Dale, Maryland."
To how many people has this research been opened up?
"In order to carry out this research, 250 participants that adhere to the clinical trial's inclusion criteria are required. Tolmar Inc. is sponsoring the trial which will be conducted at multiple sites; two examples being Maryland Oncology Hematology, P.A. in Glenn Dale, Maryland and Texas Oncology- Northeast Texas in Tyler, Illinois."
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger