Low Grade Endometrial Stromal SarcomaPhase 2BFR-ESSNCT03624244
Evaluation of Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic Low Grade Endometrial Stromal Sarcoma (LGESS)
A Phase 2 study testing Aromatase Inhibitors in people with Low Grade Endometrial Stromal Sarcoma, run by Centre Leon Berard at 22 sites in France.
Trial summary
The primary objective is to compare the progression-free survival (PFS) between aromatase inhibitors interruption and aromatase inhibitors maintenance strategies in patients with a locally advanced or metastatic Low Grade Endometrial Stromal Sarcoma (LGESS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Low Grade Endometrial Stromal Sarcoma
- What is being tested?
- Aromatase Inhibitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 22 sitesFrance
- Study dates
- 23 Jan 2019to Jan 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
France22 sites, 22 recruiting
- Recruiting
CHU Besançon
Besançon, 25030
Laura MANSI, MD, +33370632403, lmansi@chu-besancon.fr
- Recruiting
Insitut Bergonié
Bordeaux
FLOQUET Anne, A.Floquet@bordeaux.unicancer.fr
- Recruiting
Centre François Baclesse
Caen, 14076
Sabine NOAL, MD, +33231455017, s.noal@baclesse.unicancer.fr
- Recruiting
Centre Jean Perrin
Clermont-Ferrand, 63000
Pascale DUBRAY-LONGERAS, +33473278141, pascale.dubray-longeras@cjp.fr
- Recruiting
Centre Oscar Lambret
Lille, 59000
Nicolas PENEL, MD, n-penel@o-lambret.fr
- Recruiting
CHU Dupuytren
Limoges
VENAT-BOUVET Laurence, laurence.venat-bouvet@chu-limoges.fr
- Recruiting
Centre Léon Bérard
Lyon, 69373
Isabelle RAY-COQUARD, MD PhD, +33478782828, isabelle.ray-coquard@lyon.unicancer.fr
- Recruiting
Hopital La Timone
Marseille, 13005
Florence DUFFAUD, +33491385708, florence.duffaud@ap-hm.fr
- Recruiting
Hopital La Timone
Marseille, 13005
Florence DUFFAUD, MD, florence.duffaud@ap-hm.fr
- Recruiting
Institut Paoli Calmette
Marseille
BERTUCCI François, BERTUCCIF@ipc.unicancer.fr
- Recruiting
Institut de Cancérologie de Montpellier
Montpellier, 34298
Stanislas QUESADA, +330467612419, stanislas.quesada@icm.unicancer.fr
- Not yet recruiting
Centre Antoine Lacassagne
Nice, 06189
Esma SAADA-BOUZID, +33492031514, esma.saada-bouzid@nice.unicancer.fr
- Recruiting
Hopital Pitié Salpétrière
Paris, 75013
Jean-Philippe SPANO, +33142160509, jean-philippe.spano@aphp.fr
- Recruiting
AP-HP Hopîtal Cochin
Paris
ALEXANDRE Jérôme, jerome.alexandre@aphp.fr
- Recruiting
Insitut Curie
Paris
WATSON Sarah, MD, sarah.watson@curie.fr
- Recruiting
Institut Godinot
Reims
SAVOYE Aude-Marie, aude-marie.savoye@reims.unicancer.fr
- Recruiting
Centre Henri Becquerel
Rouen
GUILLEMET Cécile, cecile.guillemet@chb.unicancer.fr
- Recruiting
Hopital Privé de la Loire
Saint-Etienne, 42020
Olivier COLLARD, MD, olivier.collard@ramsaysante.fr
- Recruiting
ICO Centre René Gauducheau
Saint-Herblain, 44805
Emmanuelle BOMPAS, emmanuelle.bompas@ico.unicancer.fr
- Recruiting
CHUSE
Saint-Priest-en-Jarez
FOURNEL Pierre, MD, pierre.fournel@chu-st-etienne.fr
- Recruiting
CHU Tours
Tours, 37044
Hélène VEGAS, h.vegas@chu-tours.fr
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Patricia PAUTIER, MD, patricia.pautier@gustaveroussy.fr
About this study
Official title: Randomized Comparative Prospective Multicentre Phase II Trial Evaluating Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic LGESS
The primary objective is to compare the progression-free survival (PFS) between aromatase inhibitors interruption and aromatase inhibitors maintenance strategies in patients with a locally advanced or metastatic Low Grade Endometrial Stromal Sarcoma (LGESS).
Read the detailed description
Uterine sarcomas are rare tumors with an incidence of 1.7/100 000 women per year, including 20% of endometrial stromal sarcomas (ESS). Patients with low grade ESS (LGESS) have a good prognosis with a 5-year overall survival rates ranging from 66 to 98%, depending on the stage of the disease.
Majority of LGESS report estrogen receptor (ER) and/or progesterone receptor positive and a chromosomal translocation with JAZF1-SUZ12.
Based on the current European Society of Medical Oncology (ESMO)guidelines, the standard treatment for patients with early/non metastatic ESS is total hysterectomy plus or less bilateral salpingo-oophorectomy. The use of hormonal therapy (HT) for advanced or metastatic disease is recommended based on retrospective data from small series providing evidence that HT have an anti-tumor activity on LGESS. HT includes aromatase inhibitors (AI), progestins and gonadotrophin-releasing hormone.
Very few data are available in this rare disease, but retrospective analyses show that AI may provide response rates of 46 to 67% in metastatic LGESS patients (7% complete response, 60% partial response), with a mean duration of response of 24 months.
Even if AI are effective and well tolerated, chronical mild to moderate (grade 1-2) side-effects (arthritis, hot-flashes, osteoporosis, hypercholesterolemia, cardiac events) have a negative impact on patient's well-being because of the treatment long term duration and need to be balanced in such long term survival.
To date, the question of the optimal duration of HT in LGESS is still pending. The investigator propose an open-label, randomized, multicenter phase II study aiming at determining the feasibility of interruption of AI in patients with locally advanced or metastatic LGESS after long term stabilization or response to AI. The study will use a sequential bayesian design allowing for continuous monitoring of the main efficacy outcome, thus leading to a smaller more informative trial, and specifically tied to decision making. This design is particularly suited to characterize efficacy signals in the context of a very rare pathology. Moreover JAZF1-JJAZ1 fusion gene is not identified in all LGESS.
Ancillary studies will provide precious data aiming at:
- Identifying predictive factors of prolonged response to HT or late resistance (Next Generation Sequencing and Comparative Genome Hybridization).
- Evaluating sociobehavioral (only for French sites) of patients by following questionnaire: Zimbardo Time Perspective Inventory (ZTPI) , Functional, Communicative and Critical Health Literacy/ 14-item Health Literacy Scale (FCCHL/HLS14), VICAN, Fear of Cancer Recurrence (FCR) and Patient-Generated Index (PGI).
- Conditions
- Low Grade Endometrial Stromal Sarcoma
- Being tested
- Aromatase Inhibitors
- Keywords
- Low Grade Endometrial Stromal Sarcoma, Aromatase inhibitors
- Medical subject headings
- Endometrial Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatase InhibitorsDrug
Also called ANASTRAZOLE, ARIMIDEX, AROMASINE, EXEMESTANE, FEMARA, LETROZOLE
Maintenance of AI versus interruption of AI
| Study group | Role | What they receive |
|---|---|---|
| Interruption of aromatase inhibitors | Experimental | Interruption of aromatase inhibitors until progression disease. At disease progression, AI can be reintroduced. Receives: Drug: Aromatase Inhibitors |
| Maintenance of aromatase inhibitors | Other | Maintenance of aromatase inhibitors Receives: Drug: Aromatase Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Secondary outcomes (7)
Overall survival
Overall survival
Measured: From date of randomization to death due to any cause, assessed up to 60 months
Time to first subsequent chemotherapy/treatment or death
Time to first subsequent chemotherapy/treatment or death
Measured: From date of randomization to the earliest date of chemotherapy/treatment start date following study treatment discontinuation, or death due to any cause, whichever came first, assessed up to 60 months
Objective response rate after reintroduction of AI in the experimental arm
Proportion of patients with a best overall response of Partial Response (PR) or Complete Response (CR) after AI reintroduction in the experimental arm
Measured: From the date of AI reintroduction in the experimental arm to the date of subsequent progression or date of death due to any cause, whichever came first, assessed up to 60 months
Progression free survival after reintroduction of AI in the experimental arm
Progression free survival after reintroduction of AI in the experimental arm
Measured: From the date of AI reintroduction in the experimental arm to the date of subsequent progression or date of death due to any cause, whichever came first, assessed up to 60 months
Duration of response to AI after reintroduction
Duration of response to AI after reintroduction
Measured: From the date of first objective response following the reintroduction of AI to the date of the first subsequent documented radiological progression or death due to any cause, whichever came first, assessed up to 60 months
Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability assessed according to the NCI-CTC AE version 5
Measured: From date of randomization to follow-up visit Month 36 or death due to any cause, whichever came first, assessed up to 60 months
Quality of Life using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
Quality of Life using EORTC QLQ-C30 questionnaire. 64 questions related to cancer impact on health and daily activities composed this questionnaire. Each item has to be graded from 1 to 4 ( 1 = not at all; 4 = very much). More the score is high, worst the quality of life is.
Measured: Every 6 months until the 36th month for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start23 Jan 2019
- Primary completionJan 2028 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade Endometrial Stromal SarcomaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase II comparative multicentre prospective randomised (1:1 ratio) open-label study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle RAY-COQUARD, MD PhD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624244
- Sponsor's protocol ID
- ET17-200 BRF-ESS
- Acronym
- BFR-ESS
- Status last verified
- Feb 2026
- First submitted
- 18 Jul 2018
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparative Prospective Multicentre Phase II Trial Evaluating Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic LGESS
- ClinicalTrials.gov ID
- NCT03624244
- Acronym / sponsor ID
- BFR-ESS / ET17-200 BRF-ESS
- Conditions
- Low Grade Endometrial Stromal Sarcoma
- Keywords
- Low Grade Endometrial Stromal Sarcoma, Aromatase inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to compare the progression-free survival (PFS) between aromatase inhibitors interruption and aromatase inhibitors maintenance strategies in patients with a locally advanced or metastatic Low Grade Endometrial Stromal Sarcoma (LGESS).
Detailed description
Uterine sarcomas are rare tumors with an incidence of 1.7/100 000 women per year, including 20% of endometrial stromal sarcomas (ESS). Patients with low grade ESS (LGESS) have a good prognosis with a 5-year overall survival rates ranging from 66 to 98%, depending on the stage of the disease.
Majority of LGESS report estrogen receptor (ER) and/or progesterone receptor positive and a chromosomal translocation with JAZF1-SUZ12.
Based on the current European Society of Medical Oncology (ESMO)guidelines, the standard treatment for patients with early/non metastatic ESS is total hysterectomy plus or less bilateral salpingo-oophorectomy. The use of hormonal therapy (HT) for advanced or metastatic disease is recommended based on retrospective data from small series providing evidence that HT have an anti-tumor activity on LGESS. HT includes aromatase inhibitors (AI), progestins and gonadotrophin-releasing hormone.
Very few data are available in this rare disease, but retrospective analyses show that AI may provide response rates of 46 to 67% in metastatic LGESS patients (7% complete response, 60% partial response), with a mean duration of response of 24 months.
Even if AI are effective and well tolerated, chronical mild to moderate (grade 1-2) side-effects (arthritis, hot-flashes, osteoporosis, hypercholesterolemia, cardiac events) have a negative impact on patient's well-being because of the treatment long term duration and need to be balanced in such long term survival.
To date, the question of the optimal duration of HT in LGESS is still pending. The investigator propose an open-label, randomized, multicenter phase II study aiming at determining the feasibility of interruption of AI in patients with locally advanced or metastatic LGESS after long term stabilization or response to AI. The study will use a sequential bayesian design allowing for continuous monitoring of the main efficacy outcome, thus leading to a smaller more informative trial, and specifically tied to decision making. This design is particularly suited to characterize efficacy signals in the context of a very rare pathology. Moreover JAZF1-JJAZ1 fusion gene is not identified in all LGESS.
Ancillary studies will provide precious data aiming at:
- Identifying predictive factors of prolonged response to HT or late resistance (Next Generation Sequencing and Comparative Genome Hybridization).
- Evaluating sociobehavioral (only for French sites) of patients by following questionnaire: Zimbardo Time Perspective Inventory (ZTPI) , Functional, Communicative and Critical Health Literacy/ 14-item Health Literacy Scale (FCCHL/HLS14), VICAN, Fear of Cancer Recurrence (FCR) and Patient-Generated Index (PGI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase II comparative multicentre prospective randomised (1:1 ratio) open-label study
| Arm | Type | Receives |
|---|---|---|
| Interruption of aromatase inhibitors | Experimental | Drug: Aromatase InhibitorsInterruption of aromatase inhibitors until progression disease. At disease progression, AI can be reintroduced. |
| Maintenance of aromatase inhibitors | Other | Drug: Aromatase InhibitorsMaintenance of aromatase inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aromatase InhibitorsAlso: ANASTRAZOLE, ARIMIDEX, AROMASINE, EXEMESTANE, FEMARA, LETROZOLEMaintenance of AI versus interruption of AI | Drug | Interruption of aromatase inhibitors, Maintenance of aromatase inhibitors |
Primary outcome
Progression free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Progression free survival
7 secondary outcomes
Overall survival
Time frame: From date of randomization to death due to any cause, assessed up to 60 months
Time to first subsequent chemotherapy/treatment or death
Time frame: From date of randomization to the earliest date of chemotherapy/treatment start date following study treatment discontinuation, or death due to any cause, whichever came first, assessed up to 60 months
Objective response rate after reintroduction of AI in the experimental arm
Time frame: From the date of AI reintroduction in the experimental arm to the date of subsequent progression or date of death due to any cause, whichever came first, assessed up to 60 months
Progression free survival after reintroduction of AI in the experimental arm
Time frame: From the date of AI reintroduction in the experimental arm to the date of subsequent progression or date of death due to any cause, whichever came first, assessed up to 60 months
Duration of response to AI after reintroduction
Time frame: From the date of first objective response following the reintroduction of AI to the date of the first subsequent documented radiological progression or death due to any cause, whichever came first, assessed up to 60 months
Incidence of Treatment-Emergent Adverse Events
Time frame: From date of randomization to follow-up visit Month 36 or death due to any cause, whichever came first, assessed up to 60 months
Quality of Life using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
Time frame: Every 6 months until the 36th month for each patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle RAY-COQUARD, MD PhD principal investigator
Centre Leon Berard
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aromatase Inhibitors in people with Low Grade Endometrial Stromal Sarcoma, run by Centre Leon Berard at 22 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Séverine METZGER (+33478782786, severine.metzger@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.