Can a drug holiday help women with rare uterine cancer?
NCT ID NCT03624244
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether women with a rare, slow-growing uterine cancer (low-grade endometrial stromal sarcoma) can safely stop taking their hormone-blocking pills (aromatase inhibitors) after long-term use. Half the participants will stop the pills and half will continue, and researchers will track how long the cancer stays under control. The goal is to see if a break from medication can reduce side effects without worsening the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2019
- Expected to finish
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Jan 2031
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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Female participants only
- 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: * Age≥18 years; * Histological confirmation of low grade ESS; * Locally advanced or metastatic disease at diagnosis or patient experiencing a tumor effraction during hysterectomy; * Treatment with aromatase inhibitors (Anastrozole or Exemestane or Letrozole ) initiated either: for at least 24 months (in patients with no residual disease or non-measurable disease at the last AI initiation) OR for at least 36 months (in patients with measurable disease at the last AI initiation); * Disease must be controlled at the time of the randomisation (objective response or stable disease) by the aromatase inhibitor initiated either for at least 24 or 36 months * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 * Covered by a medical insurance; * Signed informed consent prior to any study-specific procedure. Exclusion Criteria: * Pregnant or breastfeeding woman; * Patient concurrently using other approved or investigational antineoplastic agents; * Major concurrent disease affecting cardiovascular system, liver, kidneys, hematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures or results; * Prior history of malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years; * Patients using prohibited concomitant and/or concurrent medications * Contra-indication according to SmPCs. * Patient requiring tutorship or curatorship.
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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
22 sites. 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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AP-HP Hopîtal Cochin
RECRUITINGParis, France
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CHU Besançon
RECRUITINGBesançon, 25030, France
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CHU Dupuytren
RECRUITINGLimoges, France
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CHU Tours
RECRUITINGTours, 37044, France
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CHUSE
RECRUITINGSaint-Priest-en-Jarez, France
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Centre Antoine Lacassagne
NOT_YET_RECRUITINGNice, 06189, France
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Centre François Baclesse
RECRUITINGCaen, 14076, France
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Centre Henri Becquerel
RECRUITINGRouen, France
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Centre Jean Perrin
RECRUITINGClermont-Ferrand, 63000, France
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Centre Léon Bérard
RECRUITINGLyon, 69373, France
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Centre Oscar Lambret
RECRUITINGLille, 59000, France
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Hopital La Timone
RECRUITINGMarseille, 13005, France
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Hopital La Timone
RECRUITINGMarseille, 13005, France
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Hopital Pitié Salpétrière
RECRUITINGParis, 75013, France
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Hopital Privé de la Loire
RECRUITINGSaint-Etienne, 42020, France
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ICO Centre René Gauducheau
RECRUITINGSaint-Herblain, 44805, France
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Insitut Bergonié
RECRUITINGBordeaux, France
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Insitut Curie
RECRUITINGParis, France
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Institut Godinot
RECRUITINGReims, France
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Institut Gustave Roussy
RECRUITINGVillejuif, 94805, France
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Institut Paoli Calmette
RECRUITINGMarseille, France
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Institut de Cancérologie de Montpellier
RECRUITINGMontpellier, 34298, France