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New treatment option for Uterine Leiomyosarcoma
Official title Letrozole in Uterine Leiomyosarcoma
ClinicalTrials.gov ID: NCT05649956
What this study is testing
What is Letrozole?
Letrozole is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for uterine leiomyosarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a clinical trial to test letrozole in patients with uterine leiomyosarcoma. The main question is will treatment with letrozole extend progression-free survival in patients.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patient or a legally authorized representative must have signed an approved informed consent and authorization permitting the release of personal...
- Patient must have histologically confirmed newly diagnosed uterine leiomyosarcoma with disease limited to the uterus (FIGO 2009 Stage I). Submission...
- Patient tumors must express ER positivity by immunohistochemistry (ER expression greater than 10% by immunohistochemistry). ER status test results...
- Patient must have completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks from enrollment.
- All patients must have NO measurable disease as defined by RECIST 1.1 within 6 weeks of enrollment. Measurable disease is defined as at least one...
You likely can't join if
- Exclusion Criteria 1. Patients who do not have pure uterine sarcomas (i.e., no mixed malignant mullerian tumors are permitted).
- 2\. Patients with any other severe concurrent disease, which would make the patient inappropriate for entry into this study, including significant...
- 3\. Patients with concomitant invasive malignancy or a history of prior malignancy except non-melanoma skin cancer, in situ cervical cancer, or other...
- 4\. Patients who have a history of taking any aromatase inhibitor within the past 5 years.
- 5\. Patients with active or uncontrolled systemic infection. 6. Patients with history of uncontrolled cardiac disease, i.e., uncontrolled...
- 7\. Patients currently receiving chemotherapy or radiation therapy. 8. Patients with severe hepatic impairment and/or cirrhosis. 9. Patients with...
See the full eligibility criteria
- Patient or a legally authorized representative must have signed an approved informed consent and authorization permitting the release of personal health information.
- Patient must have histologically confirmed newly diagnosed uterine leiomyosarcoma with disease limited to the uterus (FIGO 2009 Stage I). Submission of pathology report documenting uterine leiomyosarcoma histology is...
- Patient tumors must express ER positivity by immunohistochemistry (ER expression greater than 10% by immunohistochemistry). ER status test results must be provided at enrollment. Sites are required to report results of...
- Patient must have completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks from enrollment.
- All patients must have NO measurable disease as defined by RECIST 1.1 within 6 weeks of enrollment. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest...
- Patients must have an ECOG performance status of 0, 1, or 2.
- Patients must have adequate organ and marrow function as defined below: NOTE: Institutional/laboratory upper limit of normal = ULN Institutional/laboratory lower limit of normal = LLN Bone marrow function:
- Absolute neutrophil count (ANC) greater than or equal to 1500 cells/mcl
- Platelet count greater than or equal to 100,000 cells/mcl
- Hemoglobin greater than or equal to 9.0 g/dL (Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the Investigator. Initial treatment must not begin earlier than the day...
- Serum creatinine less than or equal to 1.5 x ULN Hepatic function:
- AST (aspartate aminotransferase) and ALT (alanine aminotransferase) less than or equal to 3.0 x ULN
- Serum albumin greater than or equal to 2.5 g/dL
- Patient must be at least 18 years of age.
- Patient must be able to swallow oral medication.
- Exclusion Criteria 1. Patients who do not have pure uterine sarcomas (i.e., no mixed malignant mullerian tumors are permitted).
- 2\. Patients with any other severe concurrent disease, which would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases.
- 3\. Patients with concomitant invasive malignancy or a history of prior malignancy except non-melanoma skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least three...
- 4\. Patients who have a history of taking any aromatase inhibitor within the past 5 years.
- 5\. Patients with active or uncontrolled systemic infection. 6. Patients with history of uncontrolled cardiac disease, i.e., uncontrolled hypertension (defined as systolic greater than 150 mm Hg or diastolic greater...
- 7\. Patients currently receiving chemotherapy or radiation therapy. 8. Patients with severe hepatic impairment and/or cirrhosis. 9. Patients with duodenal stent or other GI disorder/defect that would interfere with...
- 10\. Patients deemed otherwise clinically unfit for clinical trial per investigators discretion.
- 11\. Patients with known hypersensitivity to any of the excipients of letrozole. 12. Patients who are pregnant or breast-feeding. 13. Patients who are currently part of or have participated in any clinical investigation...
- 14\. Patients currently using systemic estrogens, including herbals and supplements with estrogenic properties. The use of vaginal estrogen is permitted if symptoms are refractory to moisturizers and lubricants.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Highlands Ranch, Colorado, United States
- Fort Lauderdale, Florida, United States
- Miami Beach, Florida, United States
- Atlanta, Georgia, United States
- Evanston, Illinois, United States
- Indianapolis, Indiana, United States
- New Orleans, Louisiana, United States
- Shreveport, Louisiana, United States
- Worcester, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Las Vegas, Nevada, United States
- Morristown, New Jersey, United States
- Summit, New Jersey, United States
- Albuquerque, New Mexico, United States
- Greenville, North Carolina, United States
- Columbus, Ohio, United States
- Marion, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Willow Grove, Pennsylvania, United States
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Highlands Ranch, Colorado, United States; Fort Lauderdale, Florida, United States; Miami Beach, Florida, United States; Atlanta, Georgia, United States; Evanston, Illinois, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.