Safety Extension Study for Patients with HR+, HER2- Breast Cancer Who Completed the OVELIA Study
Sponsor: Tolmar Inc.
ClinicalTrials ID:NCT05645536
This study is a follow-up to the OVELIA trial, focusing on the long-term safety of the drug TOL2506 in combination with other treatments for up to 4 years in patients with HR+, HER2-negative breast cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is designed to continue monitoring the safety and tolerability of the drug TOL2506 in patients who have already participated in the OVELIA study. It involves premenopausal women with hormone receptor-positive (HR+), HER2-negative breast cancer and men with HR+ breast cancer. The study will assess how well TOL2506 works in combination with tamoxifen or an aromatase inhibitor (AI) over a period of up to 4 years.
Eligibility Criteria
Inclusion Criteria
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Women who completed the 48-week visit in the TOL2506A study and are eligible for continued hormone therapy and ovarian suppression.
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Must be able to understand the study and provide written consent.
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Aged between 18 and 51 years.
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Men who completed the 48-week visit in the TOL2506A study and are eligible for continued hormone therapy and GnRH agonist therapy.
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Must be able to understand the study and provide written consent.
Exclusion Criteria
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Women with a body mass index (BMI) less than 18.
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Life expectancy of less than 12 months.
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Poor overall health with a performance status of 3 or higher.
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Poor liver function as indicated by specific blood tests.
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Poor kidney function as indicated by specific blood tests.
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Abnormal heart function as shown by an ECG.
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Use of new medications that affect heart rhythm.
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Any new medical or psychiatric condition that may interfere with the study.
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Use of certain hormonal medications.
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Change in how well TOL2506 is tolerated.
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Sexually active women not using two non-hormonal birth control methods.
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Positive pregnancy test.
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Men with a BMI less than 18.
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Life expectancy of less than 12 months.
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Poor overall health with a performance status of 3 or higher.
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Poor liver function as indicated by specific blood tests.
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Poor kidney function as indicated by specific blood tests.
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Abnormal heart function as shown by an ECG.
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Use of new medications that affect heart rhythm.
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Any new medical or psychiatric condition that may interfere with the study.
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Use of certain hormonal medications.
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Change in how well TOL2506 is tolerated.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Marin Cancer Care, Inc. | 94904 | Greenbrae | California |
| Holy Cross Hospital | 33308 | Fort Lauderdale | Florida |
| Baptist Health Lexington | 40503 | Lexington | Kentucky |
| Baptist Health Louisville | 40207 | Louisville | Kentucky |
| Maryland Oncology Hematology, P.A. | 21044 | Columbia | Maryland |
| Hematology Oncology Associates of Central New York, PC | 13057 | East Syracuse | New York |
| Cape Fear Valley Health Systems - Cancer Center | 28304 | Fayetteville | North Carolina |
| Lankenau Medical Center | 19096 | Wynnewood | Pennsylvania |
| Tennessee Oncology, PLLC | 37404 | Chattanooga | Tennessee |
| Tennessee Oncology | 37203 | Nashville | Tennessee |
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