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TOL2506 + Standard Therapy for Breast Cancer
Study Summary
This trial studies a drug (TOL2506) to suppress ovarian function in premenopausal women and men with breast cancer. A safety extension study will assess its long-term effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am a male taking medications that may affect my safety with TOL2506.I understand this study is experimental and I agree to participate.I am a man mostly confined to bed or chair due to my health.My liver tests are not normal, indicating poor liver function.I am a male who has finished Week 48 of the TOL2506A study and can continue hormone therapy.My doctor expects I have less than 12 months to live.I finished Week 48 of the TOL2506A study and can continue hormone therapy with ovarian suppression.My recent heart test results meet specific criteria and I haven't started any new medications or been diagnosed with new conditions.My kidney function and bone density are within normal ranges.I understand this study is experimental and I agree to participate.I am a male with a BMI under 18.My kidney function and bone density are within normal ranges.My BMI is less than 18.My recent heart test results meet specific criteria and I haven't started any new medications or been diagnosed with new conditions.I am a woman and need help with my personal care most of the time.I am a woman aged between 18 and 51.My liver tests are not within normal ranges, indicating poor liver function.I am not using medications that could affect my safety or response to TOL2506.I am a male with a life expectancy of less than 12 months.
- Group 1: 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
Is there a possibility for me to partake in this clinical research?
"This medical trial requires 250 participants with breast cancer that are between 18 and 51 years old. In addition to these criteria, potential patients must have already completed Visit 9 on TOL2506A study, comprehend the experimental nature of this investigation, provide informed consent before entering the trial."
Does this trial extend to individuals of a younger age bracket?
"Included in the prerequisites for this clinical trial is an age restriction, with participants having to be at least 18 and no older than 51."
Is TOL2506 considered safe for human consumption?
"Our assessment of TOL2506's safety is a 3, as this phase 3 trial has evidence to support its efficacy and numerous proofs indicating it can be safely administered."
Is this research trial currently enrolling participants?
"As per clinicaltrials.gov, the recruitment for this medical trial has been concluded as of December 1st 2022. Although 2604 other studies are actively looking for participants at the moment, those interested in joining this research endeavour must look elsewhere."
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