Breast cancer
Conditions
Brief summary
Change from baseline in Ki67 (the percentage of immunostaining cells).
Detailed description
Evaluation of clinical and biological response in the 2 arms by: Complete cell cycle arrest as measured by Ki67 <2.7% Clinical response (partial or complete) as measured by MRI Rate of pathological partial and complete response at surgery Changes in the levels of estradiol, FSH, and LH between baseline, D14, and D28, then postoperatively at 1 month., Incidence, duration, and severity of treatment-emergent Adverse Events (AEs) assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 5.0, including dose delays and treatment discontinuations. Incidence of ovarian cyst occurrence up to 6 months after surgery, assessed by CTCAE version 5.0
Interventions
DRUGZEULIDE 3
DRUG75 mg
DRUGpoudre et solvant pour suspension injectable à libération prolongée
DRUGElacestrant
Sponsors
Institut Gustave Roussy
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Ki67 (the percentage of immunostaining cells). | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of clinical and biological response in the 2 arms by: Complete cell cycle arrest as measured by Ki67 <2.7% Clinical response (partial or complete) as measured by MRI Rate of pathological partial and complete response at surgery Changes in the levels of estradiol, FSH, and LH between baseline, D14, and D28, then postoperatively at 1 month., Incidence, duration, and severity of treatment-emergent Adverse Events (AEs) assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 5.0, including dose delays and treatment discontinuations. Incidence of ovarian cyst occurrence up to 6 months after surgery, assessed by CTCAE version 5.0 | — |
Countries
France
Outcome results
None listed