Breast cancer drug could help fight brain tumors
NCT ID NCT03122197
First seen Jun 25, 2026 · Last updated Aug 19, 2026 · Updated 4 times
Summary
This early-phase trial tests whether letrozole, a drug normally used for breast cancer, can reach and concentrate in recurrent high-grade gliomas (aggressive brain tumors). About 39 adults will take letrozole pills daily along with standard temozolomide chemotherapy. Researchers will measure how much letrozole gets into the tumor and track side effects and survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Letrozole (Femara) and Temozolomide (Temodar)
- What this could lead to
- If it works, this could point toward a new way to treat recurrent high-grade gliomas by combining letrozole with standard chemotherapy.
- What could go wrong
- This is a very early, small trial (39 people) focused on drug levels and safety, not yet on effectiveness. The drug may not reach tumors enough or may cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 39 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2017
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Radiographically, histologically or cytologically confirmed recurrent brain high grade glioma with plan for resection or biopsy. \- Inclusion #1 for Sub-study Only: Radiographically, histologically or cytologically confirmed recurrent brain high grade glioma. 2. Age \>18 years. 3. ECOG performance status 0 -2 (Karnofsky \>60%, see Appendix A). 4. CBC/differential obtained within 28 days prior to registration on study, with adequate bone marrow function defined as follows: * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3; * Platelets ≥ 100,000 cells/mm3; * Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable). 5. Adequate hepatic function, defined as follows: * Total bilirubin \< 2 x institutional ULN within 14 days prior to registration; * AST or ALT \< 3 x institutional ULN within 14 days prior to registration. 6. Adequate renal function, defined as GFR \> 30 ml/min or Cr \< 1.5. 7. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential. 8. Imaging prior to treatment including MRI of brain (with contrast preferred but not required). 9. Ability to understand and the willingness to sign a written informed consent document. 10. Inclusion #10 for Sub-study Only: Measurable disease per RANO criteria within 28 days of starting treatment on this study. Exclusion Criteria 1. Patients may not be receiving any other investigational agents. 2. History of allergic reactions attributed to letrozole or other agents used in study. Exclusion #2 for Sub-study Only: History of allergic reactions attributed to letrozole or TMZ. 3. Uncontrolled intercurrent illness including, but not limited to, ongoing significant or serious active cardiovascular disease (CHF exacerbation, unstable angina or MI in last 6 months), or infection including the diagnosis of AIDS or active hepatitis B or C infection, or psychiatric illness or medical or personal conditions that in the opinion of the investigator would limit the patient's ability to participate. 4. Patients attempting to conceive, and pregnant or nursing women are excluded from this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Cincinnati
RECRUITINGCincinnati, Ohio, 45267, United States
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