Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT07159451

A Short-term Preoperative, 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

Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-12-01

140

Participants Needed

1

Research Sites

85 weeks

Total Duration

On this page

Sponsors

G

Gustave Roussy, Cancer Campus, Grand Paris

Lead Sponsor

M

Menarini Group

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Short-term Preoperative, 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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 years or older
  • Signed informed consent and able to follow study procedures
  • Affiliated to a Social Security System or equivalent
  • Premenopausal status confirmed by recent regular periods or hormone levels
  • Histologically confirmed invasive breast carcinoma that is ER-positive (at least 10%) and HER2-negative
  • Ki67 index between 10% and 30% on untreated tumor tissue
  • Clinical stage I or II breast cancer eligible for primary breast surgery
  • Available pre-treatment biopsy sample for evaluation
  • ECOG performance status of 0 or 1 within 14 days before randomization
  • Negative serum pregnancy test within 72 hours before starting study treatment for women of childbearing potential
  • Adequate organ function based on blood tests within 7 days before inclusion
  • Women of childbearing potential agree to use specified effective contraception during and for 120 days after treatment
Not Eligible

You will not qualify if you...

  • Not eligible for upfront breast surgery or candidate for neoadjuvant chemotherapy
  • Received systemic therapy or radiotherapy for current breast cancer before study entry
  • Prior use of LHRH-agonists in the last 6 months before consent
  • Active treatment for any cancer disease
  • Recent (within 6 months) major heart or cerebrovascular events or severe cardiac conditions
  • Child-Pugh liver score greater than Class A
  • Known severe allergy to study treatments
  • History of significant blood clotting disorders in the past 6 months, except certain treated cases
  • Current treatment with anticoagulants unless stable and appropriate for study
  • Difficulty tolerating or absorbing oral medications
  • Unable or unwilling to avoid certain medications or foods that interfere with study drugs
  • Pregnancy, breastfeeding, or planning to conceive during study and 120 days after
  • Severe medical or psychiatric conditions that increase study risk or interfere with participation
  • Legal or psychological conditions preventing study compliance
  • Unwilling or unable to comply with study protocol

AI-Screening

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Trial Site Locations

Total: 1 location

1

Gustave Roussy

Villejuif, France

Actively Recruiting

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Research Team

E

Elie El Rassy, MD

CONTACT

C

Chloé Serhal, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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