Last updated 8 days ago
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
250 patients around the world
Available in Argentina, Puerto Rico, Mexico, United States
Tolmar Inc.
6Research sites
250Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
To 49 Years
All Gender
Medical requirements
- FemaleAble to understand the investigational nature of this study and provide written informed consent prior to the participation in the trialAge 18 to 49, inclusiveDiagnosis of Stage I, II, or III HR+, HER2-negative breast cancer (ER>1% and/or, PR>1%, HER2-negative per ASCO CAP guidelines)Is a candidate for endocrine therapy + ovarian suppression LH > 4 IU/L within 28 days prior to Day 1Is premenopausal as defined by:- E2 > 30 pg/mL- follicle stimulating hormone (FSH) < 40 IU/L- follicle stimulating hormone (FSH) < 40 IU/L- regular menses (eg, menstrual cycle length of 21 to 35 days) Note: premenopausal status must be determined before neo/adjuvant chemotherapy in patients for which it is planned or prior to Day 1 in patients who did not have prior chemotherapy. If premenopausal status was not determined prior to chemotherapy, E2 and FSH must meet the above criteria when measured 2 weeks or more after the end of the final cycle of chemotherapy.
- Body mass index (BMI) < 18.00 kg/m2 or > 35.00 kg/m2BreastfeedingLife expectancy < 12 monthsEastern Cooperative Oncology Group (ECOG) performance status ≥ 3Unacceptable hepatic function as determined by any of the following:1. Alanine aminotransferase (ALT) ≥ 2X upper limit of normal (ULN)- Aspartate aminotransferase (AST) ≥ 2X ULN- Bilirubin ≥ 2X ULN- Alkaline phosphatase ≥ 2X ULN- Severe hepatic impairment (Child-Pugh Class C)Unacceptable renal function as determined by any of the following:- Creatinine ≥ 3X ULN- Creatinine clearance ≤ 30 mL/minute- Creatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal meanHistory of significantly abnormal ECG or screening 12-lead ECG demonstrating any of the following:- HR > 100 BPM- QRS > 120 msec- QTc > 450 msec- PR > 220 msecPrior (within 28 days prior to Day 1) and/or concomitant use of medications known to prolong the QT/QTc intervalPrior use of tamoxifen, other SERMs (eg, raloxifene) or antagonists (eg, fulvestrant), aromatase inhibitor, mammalian target of rapamycin (mTOR) inhibitors, or hormone replacement therapy within 3 months before breast cancer diagnosisConcomitant use of anticancer mediations other than those specified for use by the protocolPrior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancerHistory of treatment for osteopenia/osteoporosis or baseline bone mineral density Z-score ≤ -2.0Prior (within 6 months prior to Day 1) or current use of drugs known to increase bone mineral density (ie, bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab) or use of supplements known to increase bone mineral density (ie, calcitonin, fluoride, strontium) within 28 days prior to Day 1Low trauma fracture(s) occurring within 12 months prior to subject's first visit (defined as a fracture that results from a fall from a standing height or less, excluding fingers, toes, face and skull)Conditions that preclude bone mineral density measurement (lumbar spine/bilateral hip surgery with hardware in place, abdominal clips, umbilical ring [not willing to remove] or weight that exceeds the DEXA machine limitation)Any other medical condition or serious illness, presence of a second malignancy under current treatment or follow-up, or the presence of clinically significant findings on the physical exam, laboratory testing, medical history (including conditions that may be associated with low bone mass), that in the opinion of the Investigator may interfere with trial conduct, subject safety, or interpretation of study resultsAlready receiving and/or previously received GnRH analogs within 1 year before breast cancer diagnosisPsychiatric, addictive, or other disorders that would preclude study complianceUse of medications that may impact subject safety and/or affect the PK of the drug and hormonal assessments including but not limited to:- Oral or transdermal hormonal therapy within 30 days prior to subject's first visit- Estrogen, progesterone, or androgens within 30 days prior to subject's first visit- Hormonal contraceptives within 30 days prior to subject's first visit- Medications known to result in clinically important decreases in bone mass taken within 6 months prior to subject's first visitKnown hypersensitivity, idiosyncratic, or allergic reactions to GnRH, GnRH agonist/analogs or to any of the components of the IPSexually active with a male partner and not willing to use non-hormonal contraceptive methods throughout the studyIs of childbearing potential with a positive serum pregnancy test at Screening or urine pregnancy test at Day 1Exposure to any investigational agent within 30 days prior to the first dose of TOL2506
Sites
Hospital Británico de Buenos Aires - CABA
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Hospital Alemán
Recruiting
FAICIC Clinical Research
Recruiting
Unidad de Medicina Especializada SMA
Recruiting
FDI Clinical Research
Recruiting
StudyOVELIA
SponsorTolmar Inc.
Study typeInterventional
Conditions
Breast Cancer
Requirements
To 49 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04906395
