Trial that evaluates the interest of interruption versus maintaining the treatment of aromatase inhibitors in patients with metastatic low grade endometrial stromal sarcoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Leon Berard

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

23 Jan 2019 → ongoing

Decision date (initial)

2024-09-19

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS · INCa

External identifiers

EU CT number

2024-512629-97-00

EudraCT number

2017-004876-71

ClinicalTrials.gov

NCT03624244

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy

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.

Secondary objectives 8

1. - To compare between arms:the overall survival (OS)
2. ✓ the safety
3. ✓ the Quality of Life (QoL)
4. ✓ the time to first subsequent chemotherapy/treatment
5. - To determine the progression-free survival after AI reintroduction in the experimental arm
6. - To determine the objective response rate (ORR) after reintroduction of AI in the experimental arm
7. - To determine the duration of response to AI after reintroduction in the experimental arm.
8. Exploratory objectives:  Translational: To identify predictive factors of prolonged response to HT or late resistance (Next Generation Sequencing and Comparative Genome Hybridization).

Conditions and MedDRA coding

Patients with locally advanced or metastatic low grade endometrial stroma sarcoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. I1. Age≥18 years;
2. I2. Histological confirmation of low grade ESS;
3. I3. Patient experiencing a tumor effraction during surgery or locally advanced or metastatic disease at diagnosis, or relapsed disease after initial therapy
4. 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)
5. 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)
6. I6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
7. I7. Covered by a medical insurance
8. I8. Signed informed consent prior to any study-specific procedure.

Exclusion criteria 7

1. E1. Pregnant or breastfeeding woman
2. E2. Patient concurrently using other approved or investigational antineoplastic agents
3. 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
4. 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.
5. E5. Patients using prohibited concomitant and/or concurrent medications (see section “Prohibited concomitant/concurrent treatments).
6. E6. Contra-indication according to SmPCs.
7. E7. Patient requiring tutorship or curatorship.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 4

1. Between arms: ✓ the overall survival (OS)✓ the safety, ✓ the Quality of Life (QoL), ✓ the time to first subsequent chemotherapy;
2. The progression-free survival (PFS) after AI reintroduction in the experimental arm
3. The objective response rate (ORR) after reintroduction of AI in the experimental arm
4. The duration of response to AI after reintroduction in the experimental arm.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Leon Berard

Sponsor organisation

Centre Leon Berard

Address

28 Rue Laennec

City

Lyon

Postcode

69008

Country

France

Scientific contact point

Organisation

Centre Leon Berard

Contact name

Pr Isabelle RAY-COQUARD

Public contact point

Organisation

Centre Leon Berard

Contact name

Clinical Operations Manager

Locations

1 EU/EEA country · 21 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications