Informations générales (source: ClinicalTrials.gov)
A Short-term Preoperative, Window-of-opportunity Study, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer
Interventional
Phase 2
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
octobre 2025
mai 2027
02 décembre 2025
A prospective randomized trial designed to evaluate the mean decrease in Ki67 after 4
weeks of elacestrant monotherapy and in combination with leuprorelin in patients with
early-stage HR+ BC. This preoperative study will enroll consecutive patients with early
stage HR+ BC who are not candidates for neoadjuvant chemotherapy but are eligible for
short-term preoperative treatment with elacestrant, with or without leuprorelin, followed
by breast surgery. A total of three dedicated Formalin-fixed paraffin embedded (FFPE)
samples (mandatory for all patients), along with two frozen biopsy (only for participants
at Gustave Roussy), are planned to be collected at the time of inclusion from the biopsy
sample and from the surgical specimen. Blood samples will also be collected throughout
the study.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Jean ZEGHONDY | 20/04/2026 09:45:07 | Contact (sur clinicalTrials) | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Gustave Roussy - Villejuif 2968705 - France | Jean Zeghondy, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
Each patient must meet all of the following inclusion criteria to be randomized in the
study:
1. Aged 18 or more.
2. Signed Informed Consent Form prior to any study-specific procedure. Patients must be
willing and able to comply with the protocol for the duration of the study including
scheduled visits, treatment plan, laboratory tests and other study procedures.
3. Patients must be affiliated to a Social Security System (or equivalent).
4. Premenopausal women ensured by checking if the women were still having regular
periods over the last 6 months without any hormonal treatment or hormonal
contraception or if they were irregular, FSH and estradiol levels must fall within
the premenopausal range according to local laboratory definition.
5. Histologically confirmed invasive breast carcinoma, confirmed by the local
pathologist, ER-positive tumor cells ≥ 10% ER staining BC and HER2- according to
ASCO criteria in immunohistochemistry (IHC) and/or genomic analysis (HER2 negativity
is defined as IHC 0-1+, or [IHC 2+ and in situ hybridization non-amplified]), Ki67
index by local analysis of ≥ 10% and ≤ 30% on untreated tumor tissue.
6. Clinical stage I or II according to the eight edition of the American Joint
Committee on Cancer, eligible for primary breast surgery.
Note: Multifocal and multicentric tumors are permitted if they are considered
clinical stage I or II according to Eight Edition of the AJCC. Biopsy of all lesions
is not necessary and is left at the description of the investigator, but endocrine
therapy response must be evaluated on the same tumor
7. Available pre-treatment tru-cut biopsy evaluable.
8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Evaluation of ECOG is to be performed within 14 days prior to the date of
randomization.
9. Women of childbearing potential have a negative serum pregnancy test within 72 hours
prior to receiving the first dose of study medication.
10. Demonstrate adequate organ function within 7 days of inclusion :
1. Absolute neutrophil count ≥ 1.0 x 109/L
2. Platelet count ≥ 75 x 109/L
3. Hemoglobin ≥ 9.0 g/dL
4. Estimated glomerular filtration rate ≥30 mL/min/1.73 m² or creatinine clearance
calculated by Cockcroft-Gault equation ≥ 30 mL/min Creatinine clearance ≥ 30
mL/min for subject with creatinine levels > 1.5 x institutional upper limit of
normal (ULN).
5. Alanine aminotransferase (ALT) ≤ 2.5x upper limit of normal (ULN).
6. Aspartate aminotransferase (AST) ≤ 3x ULN.
7. Total bilirubin ≤ ULN or total bilirubin ≤ 1.5x ULN with direct bilirubin ≤ ULN
of the laboratory in subjects with documented Gilbert's Syndrome.
8. Potassium, sodium, calcium (corrected for albumin), magnesium, and phosphorus
CTCAE v5.0 Grade ≤ 1. If Screening assessments are abnormal, chemistry
assessments may be repeated up to 2 times; subjects may receive appropriate
supplementation or treatment (eg, for hypercalcemia) prior to re-assessment.
9. International normalized ratio (INR) ≤ 1.5; subjects who are receiving
anticoagulation treatment which is monitored by international normalized ratio
(INR) (eg, warfarin) may be allowed to participate if they have a stable INR
(ie, within therapeutic range) for at least 28 days prior to the first dose of
study drug, in the absence of any exclusionary medical conditions, and provided
that elacestrant would be appropriate therapy for the subject.
11. Women of childbearing potential must agree to use protocol-specified method(s) of
contraception during trial treatments and for at least 120 days after the last dose
of trial treatments. Highly effective contraception methods include:
1. Total abstinence (when this is in line with the preferred and usual lifestyle
of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal,
post-ovulation methods) and withdrawal are not acceptable methods of
contraception.
2. Placement of a non-hormonal intrauterine device.
Exclusion Criteria:
Patients who meet any of the following exclusion criteria will not be eligible for this
study.
1. Patients non-candidate for upfront breast surgery or candidate for neoadjuvant
chemotherapy.
2. Any systemic therapy (e.g, chemotherapy, targeted therapy, immune-therapy) or
radiotherapy for current BC before study entry.
3. Prior treatment with LHRH-agonists over the last 6 months prior to the ICF
signature.
4. Any active treatment for any cancer disease.
5. Any of the following within 6 months before enrollment:
1. Myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of
NCI CTCAE v5.0 Grade ≥2,
2. Prolonged QTcF ≥ Grade 2 (ie, > 480 msec), uncontrolled atrial fibrillation of
any grade, coronary/peripheral artery bypass graft, heart failure ≥ Class II as
defined by the New York Heart Association guidelines,
3. Cerebrovascular accident including transient ischemic attack
4. Child-Pugh Score greater than Class A,
5. Has a known hypersensitivity (≥ Grade 3) to the components of the study therapy
or its analogs.
6. Coagulopathy or any history of coagulopathy within the past 6 months, including
history of deep vein thrombosis or pulmonary embolism. However, subjects with
the following conditions will be allowed to participate:
7. Adequately treated catheter-related venous thrombosis occurring > 28 days prior
to the first dose of study drug
6. Treatment with an anticoagulant, eg, warfarin or heparin, for a thrombotic event
occurring > 6 months before enrollmentenrolment, or for an otherwise stable and
allowed medical condition (eg, well controlled atrial fibrillation), provided dose
and coagulation parameters (as defined by local standard of care) are stable for at
least 28 days prior to the first dose of study drug and provided that an AI would be
an appropriate therapy for the subject.
7. Known difficulty in tolerating oral medications or conditions which would impair
absorption of oral medications such as: uncontrolled nausea or vomiting (ie, CTCAE ≥
Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction/motility
disorder, malabsorption syndrome, or prior gastric bypass.
8. Unable or unwilling to avoid prescription medications, over-the-counter medications,
dietary/herbal supplements (eg, St. John's wort), and/or foods (eg, grapefruit,
pomelos, star fruit, Seville oranges and their juices) that are moderate/strong
inhibitors or inducers of CYP3A4 activity. Participation will be allowed if the
medication, supplements, and/or foods are discontinued for at least 5 half-lives or
14 days (whichever is longer) prior to study entry and for the duration of the
study.
9. Pregnancy or breastfeeding or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of trial treatment. If barrier contraceptives are being used,
these must be continued throughout the trial by both sexes.
10. Any concurrent severe, acute, or chronic medical or psychiatric condition or
laboratory abnormality that may increase the risk associated with study
participation or investigational product administration or may interfere with
compliance with study procedures or the interpretation of study results and, in the
judgment of the Investigator, would make the subject inappropriate for entry into
this study.
11. Person deprived of their liberty or under protective custody or guardianship.
12. Psychological, familial, sociological or geographical conditions that do not permit
compliance with the study protocol.
13. Patients unwilling to or unable (as assessed by the investigator) to comply with the
protocol.