Phase II, multicenter, randomized, open-label study of premenopausal women with luminal breast cancer investigating the effect of elacestrant (oral selective estrogen receptor degrader) with/without triptorelin on the estrogen receptor functional pathway and Ki67 proliferation. Preoperative trial - PremiÈRe.
- Conditions
- Premenopausal women with early luminal breast cancerTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-503373-37-01
- Lead Sponsor
- Solti Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
Signed informed consent must be obtained prior to any trial-specific procedure., Ki67 expression = 10% and = 35% by local assessment., Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1., Breast cancer eligible for primary surgery., Availability of pre-treatment tumor tissue sample of FFPE tumor block from primary tumor for biomarker analysis. The tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for quality prior to randomization. Archival tumor tissue or ex professo biopsy are acceptable, Adequate hematologic and organ function, defined by the following: a.Neutrophils (ANC =1.000/µL). b.Hemoglobin = 9.0 g/dL (with no need for transfusions). c.Platelet count = 75. 000/µL. d.Serum creatinine =1.5 mg/dL or calculated creatinine clearance =30 mL/min (Cockcroft-Gault Equation) e.International normalized ratio (INR) or prothrombin time (PT) =1.5 × ULN and activated partial thromboplastin time (aPTT) within therapeutic rangeNote: Subjects who are receiving anticoagulation treatment which is monitored by 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 f.Potassium, total Calcium (corrected for serum albumin), and sodium NCI CTCAE v5.0 Grade = 1. g.Alanine aminotransferase (ALT) = 3x upper limit of normal (ULN) h.Aspartate aminotransferase (AST) = 3x ULN i.Total bilirubin = ULN or total bilirubin = 1.5x ULN with direct bilirubin = ULN of the laboratory in subjects with documented Gilbert’s Syndrome, Female patients who are at least 35 years of age on the day of signing informed consent., Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures., 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., 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., 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: •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. •Placement of a non-hormonal intrauterine device (IUD). Notes: Use of oral (estrogen and progesterone), transdermal, injected, implanted, hormone containing intrauterine system, or any other hormonal methods of contraception is not allowed in this trial. Women are considered of CBP unless: they have had = 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e., age-appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least four weeks prior to randomization. In the ca
Inoperable locally advanced or inflammatory breast cancer (any stage III)., Any treatment, local or systemic, including prior chemotherapy, ET, targeted therapy, and/or radiation therapy for the currently diagnosed BC prior to randomization., Major surgical procedure or significant traumatic injury within 28 days prior to randomization., Child-Pugh Score greater than Class A (i.e., score >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: a.Adequately treated catheter-related venous thrombosis occurring <28 days prior to randomization. b.Treatment with an anticoagulant, e.g., warfarin or heparin, for a thrombotic event occurring < 6 months before randomization, 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 in therapeutic range prior to the first dose of study drug and provided that an AI would be an appropriate therapy for the subject, Known hypersensitivity to any of the study drugs, including excipients., Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE = Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction/motility disorder, malabsorption syndrome, or prior gastric bypass., History of or clinical evidence of significant co-morbidities that, in the judgment of the investigator, may interfere with the conduction of the study, the evaluation of response, or with informed consent., Previous hormonal treatments for other indications such as osteoporosis, breast cancer prevention, hormonal substitutive therapy, such as raloxifene, tamoxifen, estrogen, progestins must have ended at least 12 months prior to trial registration. If a patient is on natural products known to contain progestins, they must be stopped 14 days prior to beginning study treatment., Used any prescription medication during the prior 1 month that the investigator judge is likely to interfere with the study or to pose an additional risk to the patient in participating., Female subject who is pregnant or breastfeeding or intends to become pregnant during the study., Assessment by the investigator to be unable or unwilling to comply with the requirements of the protocol., Any of the following within 6 months before randomization: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE v5.0 Grade = 2, prolonged QTcF = Grade 2 (i.e., > 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, or cerebrovascular accident including transient ischemic attack., Metastatic (Stage IV) breast cancer., Synchronous invasive bilateral or multicentric breast cancer., Patients requiring immediate neoadjuvant chemotherapy or immediate surgical intervention., Patients who have undergone sentinel lymph node biopsy or tumor excisional biopsy prior to study treatment., Prior malignancy within 3 years prior to randomization, except curatively treated non-melanoma skin cancer, in situ cancer or adequately and curatively treated Stage I or II cancer from which the patient is currently in complete remissio
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method