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TOL2506 + Standard Therapy for Breast Cancer
Phase 3
Waitlist Available
Research Sponsored by Tolmar Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females: Age 18 to 51 inclusive
Be between 18 and 65 years old
Must not have
Males: ECOG performance status ≥ 3
Females: Unacceptable hepatic function as determined by ALT, AST, Bilirubin, Alkaline phosphatase, or severe hepatic impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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.
Who is the study for?
This trial is for premenopausal women and men with HR+, HER2- breast cancer who completed the TOL2506A study. Women must be aged 18 to 51, and all participants should consent to continue therapy. Exclusions include severe health issues like poor heart, liver or kidney function, low BMI (<18), high ECOG status (≥3), certain medications that affect safety or response to treatment, and life expectancy less than a year.
What is being tested?
The study tests the long-term safety of TOL2506 combined with tamoxifen or an aromatase inhibitor (AI) in suppressing ovarian function in women and endocrine plus GnRH agonist therapy in men for up to four years after completing the initial OVELIA study.
What are the potential side effects?
While specific side effects are not listed here, common ones related to treatments like TOL2506 may include hot flashes, mood swings, injection site reactions for GnRH agonists; tamoxifen can cause blood clots and uterine changes; AIs might lead to bone thinning or joint pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged between 18 and 51.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am a man mostly confined to bed or chair due to my health.
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My liver tests are not normal, indicating poor liver function.
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My doctor expects I have less than 12 months to live.
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My recent heart test results meet specific criteria and I haven't started any new medications or been diagnosed with new conditions.
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My kidney function and bone density are within normal ranges.
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I am a male with a BMI under 18.
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My kidney function and bone density are within normal ranges.
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My BMI is less than 18.
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I am a woman and need help with my personal care most of the time.
Select...
My liver tests are not within normal ranges, indicating poor liver function.
Select...
I am a male with a life expectancy of less than 12 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
1Treatment groups
Experimental Treatment
Group I: TOL2506Experimental Treatment5 Interventions
TOL2506 in combination with standard endocrine therapy (Tamoxifen \& Aromatase Inhibitors)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamoxifen
2005
Completed Phase 4
~30090
Letrozole tablets
2022
Completed Phase 4
~370
Find a Location
Who is running the clinical trial?
Tolmar Inc.Lead Sponsor
4 Previous Clinical Trials
1,123 Total Patients Enrolled
1 Trials studying Breast Cancer
250 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: TOL2506
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
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