Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer (NCT05982093) | Clinical Trial Compass
RecruitingPhase 2
Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer
Spain96 participantsStarted 2023-02-03
Plain-language summary
PREMIERE parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory window of opportunity study in premenopausal women with primary operable HR+/HER2-negative breast cancer with aiming at evaluating the biological effects of elacestrant with or without triptorelin.
Who can participate
Age range35 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Signed informed consent must be obtained prior to any trial-specific procedure.
ā. Female patients who are at least 35 years of age on the day of signing informed consent.
ā. Patient is premenopausal at the time of study entry
ā. Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast untreated and recently diagnosed, with all the following characteristics:
ā. ER-positive with expression higher than 10% and HER2-negative tumor
ā. Ki67 expression ā„ 10% and ā¤ 35% by local assessment
ā. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
ā. Breast cancer eligible for primary surgery.
Exclusion criteria
ā. Potassium, total Calcium (corrected for serum albumin), and sodium NCI CTCAE v5.0 Grade ā¤ 1.
ā. Alanine aminotransferase (ALT) ā¤ 3x upper limit of normal (ULN)
ā. Aspartate aminotransferase (AST) ā¤ 3x ULN
ā. Total bilirubin ā¤ ULN or total bilirubin ā¤ 1.5x ULN with direct bilirubin ā¤ ULN of the laboratory in subjects with documented Gilbert's Syndrome
ā
What they're measuring
1
To evaluate the biological activity of elacestrant with or without OFS in premenopausal women with ER+/HER2- operable EBC
1. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.
ā2. Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant, must have confirmed negative serum pregnancy test within 7 days prior to randomization.
ā3. Female subjects must not donate, or retrieve for their own use, oocytes from the time of screening and throughout the study treatment period, and for at least 120 days after the time of final study drug administration.
ā4. Women of CBP must be willing to use highly effective methods of contraception. Contraception must continue during the trial treatment and after stopping the treatment received according to protocol. Highly effective contraception methods include: