Clinical trial • Phase IV • Oncology

Anastrozole for Locally advanced or metastatic low-grade endometrial stromal sarcoma

Phase IV trial of Anastrozole for Locally advanced or metastatic low-grade endometrial stromal sarcoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Locally advanced or metastatic low-grade endometrial stromal sarcoma
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
23-07-2024
First CTIS Authorization Date
19-09-2024

Trial design

Randomised, intervention arms: interruption of aromatase inhibitor treatment versus maintenance of aromatase inhibitor treatment. allowed aromatase inhibitors specified in the protocol: anastrozole (arimidex) 1 mg daily, exemestane (aromasine) 25 mg daily, letrozole up to 2.5 mg daily (as per the marketed product smpcs). no other drug comparator specified.-controlled, adaptive Phase IV trial across 21 sites in France.

Randomised
Yes
Comparator
Intervention arms: interruption of aromatase inhibitor treatment versus maintenance of aromatase inhibitor treatment. Allowed aromatase inhibitors specified in the protocol: Anastrozole (ARIMIDEX) 1 mg daily, Exemestane (AROMASINE) 25 mg daily, Letrozole up to 2.5 mg daily (as per the marketed product SmPCs). No other drug comparator specified.
Adaptive
True, sequential Bayesian design allowing for continuous monitoring of the main efficacy outcome (continuous monitoring/interim decision processes as described).
Target Sample Size
40

Eligibility

Recruits 40 Vulnerable populations not selected. Patients requiring tutorship or curatorship are excluded (E7). All participants must be adults (Age≥18 years) and female; signed informed consent is required prior to any study-specific procedure (I8)..

Pregnancy Exclusion
E1. Pregnant or breastfeeding woman
Vulnerable Population
Vulnerable populations not selected. Patients requiring tutorship or curatorship are excluded (E7). All participants must be adults (Age≥18 years) and female; signed informed consent is required prior to any study-specific procedure (I8).

Inclusion criteria

  • {"criterion_text":"- I1. Age≥18 years;\n- I2. Histological confirmation of low grade ESS;\n- I3. Patient experiencing a tumor effraction during surgery or locally advanced or metastatic disease at diagnosis, or relapsed disease after initial therapy\n- I4. Treatment with an aromatase inhibitor (Anastrozole or Exemestane or Letrozole) initiated either: ➢ for at least 24 months (in patients with no residual or non-measurable disease at the last AI initiation), ➢ for at least 36 months (in patients with measurable disease at the last AI initiation)\n- I5. Disease must be controlled at the time of the randomisation (objective response or stable disease) by the aromatase inhibitors initiated either for at least 24 or 36 months (see I4)\n- I6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2\n- I7. Covered by a medical insurance\n- I8. Signed informed consent prior to any study-specific procedure."}

Exclusion criteria

  • {"criterion_text":"- E1. Pregnant or breastfeeding woman\n- E2. Patient concurrently using other approved or investigational antineoplastic agents\n- E3. 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\n- E4. 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.\n- E5. Patients using prohibited concomitant and/or concurrent medications (see section “Prohibited concomitant/concurrent treatments).\n- E6. Contra-indication according to SmPCs.\n- E7. Patient requiring tutorship or curatorship."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-Free Survival (PFS), defined as the time from date of randomization to date of the first documented radiological progression (RECIST 1.1) or death due to any cause.","definition_or_measurement_approach":"Defined as the time from date of randomization to date of the first documented radiological progression (RECIST 1.1) or death due to any cause."}

Secondary endpoints

  • {"endpoint_text":"- Between arms: ✓ the overall survival (OS)✓ the safety, ✓ the Quality of Life (QoL), ✓ the time to first subsequent chemotherapy;","definition_or_measurement_approach":"Composite listing of between-arms comparisons: overall survival, safety, quality of life, time to first subsequent chemotherapy; specific measurement approaches not detailed in the available record."}
  • {"endpoint_text":"- The progression-free survival (PFS) after AI reintroduction in the experimental arm","definition_or_measurement_approach":"PFS after AI reintroduction in experimental arm; measured as time from AI reintroduction to radiological progression or death (detailed definition not provided beyond primary PFS definition)."}
  • {"endpoint_text":"- The objective response rate (ORR) after reintroduction of AI in the experimental arm","definition_or_measurement_approach":"Objective response rate after AI reintroduction; specific response criteria not detailed in the available record (likely RECIST 1.1 as used for PFS)."}
  • {"endpoint_text":"- The duration of response to AI after reintroduction in the experimental arm.","definition_or_measurement_approach":"Duration of response after AI reintroduction; specific measurement approach not provided in the available record."}

Recruitment

Planned Sample Size
40
Recruitment Window Months
132
Consent Approach
Signed informed consent required from each participant prior to any study-specific procedure (I8). Participants are adults (Age≥18); no assent process is described. Subject information and informed consent form documents (L1_SIS and ICF and addendum) are listed among trial documents.

Geography

Total Number Of Sites
21
Total Number Of Participants
40

France

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
726
Number Of Sites
21
Number Of Participants
40

Sites

Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Oncologie médicale
Principal Investigator Name
Thierry MURON
Principal Investigator Email
thierry.muron@chu-st-etienne.fr
Contact Person Name
Thierry MURON
Site Name
Centre Henri Becquerel
Department Name
Oncologie médicale
Principal Investigator Name
Cécile GUILLEMET
Principal Investigator Email
cecile.guillemet@chb.unicancer.fr
Contact Person Name
Cécile GUILLEMET
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncologie médicale
Principal Investigator Name
Jérôme ALEXANDRE
Principal Investigator Email
jerome.alexandre@aphp.fr
Contact Person Name
Jérôme ALEXANDRE
Contact Person Email
jerome.alexandre@aphp.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Oncologie médicale
Principal Investigator Name
Hélène VEGAS
Principal Investigator Email
h.vegas@chu-tours.fr
Contact Person Name
Hélène VEGAS
Contact Person Email
h.vegas@chu-tours.fr
Site Name
Institut Godinot
Department Name
Oncologie médicale
Principal Investigator Name
Aude-Marie SAVOYE
Principal Investigator Email
aude-marie.savoye@reims.unicancer.fr
Contact Person Name
Aude-Marie SAVOYE
Site Name
Centre Oscar Lambret
Department Name
Oncologie médicale
Principal Investigator Name
Loïc LEBELLEC
Principal Investigator Email
l-lebellec@o-lambret.fr
Contact Person Name
Loïc LEBELLEC
Contact Person Email
l-lebellec@o-lambret.fr
Site Name
Centre Antoine Lacassagne
Department Name
Oncologie médicale
Principal Investigator Name
Esma SAADA-BOUZID
Principal Investigator Email
esma.saada-bouzid@nice.unicancer.fr
Contact Person Name
Esma SAADA-BOUZID
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie médicale
Principal Investigator Name
Emmanuelle BOMPAS
Principal Investigator Email
emmanuelle.bompas@ico.unicancer.fr
Contact Person Name
Emmanuelle BOMPAS
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Oncologie médicale
Principal Investigator Name
Laurence VENAT-BOUVET
Principal Investigator Email
Laurence.venat-bouvet@chu-limoges.fr
Contact Person Name
Laurence VENAT-BOUVET
Site Name
Institut Curie
Department Name
Oncologie médicale
Principal Investigator Name
Sarah WATSON
Principal Investigator Email
sarah.watson@curie.fr
Contact Person Name
Sarah WATSON
Contact Person Email
sarah.watson@curie.fr
Site Name
CHU Besancon
Department Name
Oncologie médicale
Principal Investigator Name
Laura MANSI
Principal Investigator Email
lmansi@chu-besancon.fr
Contact Person Name
Laura MANSI
Contact Person Email
lmansi@chu-besancon.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical oncologist
Principal Investigator Name
Stanislas QUESADA
Principal Investigator Email
stanislas.quesada@icm.unicancer.fr
Contact Person Name
Stanislas QUESADA
Site Name
Centre Leon Berard
Department Name
Oncologie médicale
Principal Investigator Name
Isabelle RAY-COQUARD
Principal Investigator Email
isabelle.ray-coquard@lyon.unicancer.fr
Contact Person Name
Isabelle RAY-COQUARD
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Oncologie médicale
Principal Investigator Name
Florence DUFFAUD
Principal Investigator Email
florence.duffaud@ap-hm.fr
Contact Person Name
Florence DUFFAUD
Contact Person Email
florence.duffaud@ap-hm.fr
Site Name
Institut Gustave Roussy
Department Name
Oncologie médicale
Principal Investigator Name
Patricia PAUTIER
Principal Investigator Email
patricia.pautier@gustaveroussy.fr
Contact Person Name
Patricia PAUTIER
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncologie médicale
Principal Investigator Name
Johanna WASSERMANN
Principal Investigator Email
johanna.wassermann@aphp.fr
Contact Person Name
Johanna WASSERMANN
Contact Person Email
johanna.wassermann@aphp.fr
Site Name
Centre Jean Perrin
Department Name
Oncologie médicale
Principal Investigator Name
Pascale DUBRAY-LONGERAS
Contact Person Name
Pascale DUBRAY-LONGERAS
Site Name
Institut Paoli Calmettes
Department Name
Oncologie médicale
Principal Investigator Name
François BERTUCCI
Principal Investigator Email
bertuccif@ipc.unicancer.fr
Contact Person Name
François BERTUCCI
Contact Person Email
bertuccif@ipc.unicancer.fr
Site Name
Institut Bergonie
Department Name
Oncologie médicale
Principal Investigator Name
Coriolan LEBRETON
Principal Investigator Email
c.lebreton@bordeaux.unicancer.fr
Contact Person Name
Coriolan LEBRETON
Site Name
Centre Francois Baclesse
Department Name
Oncologie médicale
Principal Investigator Name
Sabine NOAL
Principal Investigator Email
s.noal@baclesse.unicancer.fr
Contact Person Name
Sabine NOAL
Contact Person Email
s.noal@baclesse.unicancer.fr
Site Name
Hopital Prive De La Loire
Department Name
Oncologie médicale
Principal Investigator Name
Cécile VASSAL
Principal Investigator Email
cecile.vassal@ramsaysante.fr
Contact Person Name
Cécile VASSAL
Contact Person Email
cecile.vassal@ramsaysante.fr

Sponsor

Primary sponsor

Full Name
Centre Leon Berard
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Third parties

  • {"country":"","full_name":"DGOS","duties_or_roles":"Monetary support","organisation_type":""}
  • {"country":"","full_name":"INCa","duties_or_roles":"Monetary support","organisation_type":""}

Investigational products

Investigational Product Name
ARIMIDEX 1 mg, comprimé pelliculé
Active Substance
Anastrozole
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
marketed product
Starting Dose
1 mg daily
Dose Levels
1 mg
Frequency
daily
Maximum Dose
1 mg daily
Investigational Product Name
AROMASINE 25 mg, comprimé enrobé
Active Substance
Exemestane
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
marketed product
Starting Dose
25 mg daily
Dose Levels
25 mg
Frequency
daily
Maximum Dose
25 mg daily
Investigational Product Name
LETROZOLE
Active Substance
Letrozole
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
marketed product
Starting Dose
2.5 mg daily
Dose Levels
2.5 mg
Frequency
daily
Maximum Dose
2.5 mg daily

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