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Trial that evaluates the interest of interruption versus maintaining the treatment of aromatase inhibitors in patients with metastatic low grade endometrial stromal sarcoma
EU CTIS ID: 2024-512629-97-00
What this study is testing
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 LGESS.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- I1. Age≥18 years;
- I2. Histological confirmation of low grade ESS;
- I3. Patient experiencing a tumor effraction during surgery or locally advanced or metastatic disease at diagnosis, or relapsed disease after initial therapy
- 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)
- 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)
- I6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
You likely can't join if
- E1. Pregnant or breastfeeding woman
- E2. Patient concurrently using other approved or investigational antineoplastic agents
- 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
- 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.
- E5. Patients using prohibited concomitant and/or concurrent medications (see section “Prohibited concomitant/concurrent treatments).
- E6. Contra-indication according to SmPCs.
See the full eligibility criteria
- I1. Age≥18 years;
- I2. Histological confirmation of low grade ESS;
- I3. Patient experiencing a tumor effraction during surgery or locally advanced or metastatic disease at diagnosis, or relapsed disease after initial therapy
- 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)
- 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)
- I6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
- I7. Covered by a medical insurance
- I8. Signed informed consent prior to any study-specific procedure.
- E1. Pregnant or breastfeeding woman
- E2. Patient concurrently using other approved or investigational antineoplastic agents
- 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
- 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.
- E5. Patients using prohibited concomitant and/or concurrent medications (see section “Prohibited concomitant/concurrent treatments).
- E6. Contra-indication according to SmPCs.
- E7. Patient requiring tutorship or curatorship.
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.