Breast Cancer
Conditions
Interventions
This is a phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 to suppress ovarian function in premenopausal women with HR+, HER2-negative breast cancer. The study will also a
D12.644.548.365.740.320.400
Sponsors
Fundação do ABC - Faculdade de Medicina do ABC
LatinaBA
Eligibility
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: Female: Able to understand the investigational nature of this study and provide written informed consent prior to the participation in the trial; Age 18 to 49, inclusive; Diagnosis 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 1; Is premenopausal as defined by:E2 > 30 pg/mL; follicle-stimulating hormone (FSH) 1% and/or, PR>1%, HER2-negative per ASCO CAP guidelines); Is a candidate for endocrine therapy + GnRH agonist
Exclusion criteria
Exclusion criteria: Female: Body mass index (BMI) 35.00 kg/m2. Breastfeeding. Life expectancy 100 BPM; QRS > 120 msec; QTc > 450 msec; PR > 220 msec. Prior (within 28 days prior to Day 1) and/or concomitant use of medications known to prolong the QT/QTc interval. Prior 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 diagnosis. Concomitant use of anticancer mediations other than those specified for use by the protocol. Prior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancer. History of treatment for osteopenia/osteoporosis. Prior (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 1. Low 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 results. Already receiving and/or previously received GnRH analogs within 1 year before breast cancer diagnosis. Psychiatric, addictive, or other disorders that would preclude study compliance. Use 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 visit. Known hypersensitivity, idiosyncratic, or allergic reactions to GnRH, GnRH agonist/analogs or to any of the components of the IP. Sexually active with a male partner and not willing to use non-hormonal contraceptive metho
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To obtain ovarian suppression, as verified by LH level quantified by enzyme-linked immunosorbent assay (ELISA) method and defined as = 90% of all subjects with LH levels < 4 IU/L at Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the percent of all subjects with LH levels < 4 IU/L at Weeks 12, 24, 36, and 48 and overall (maintained from Week 6 to 48), quantified by enzyme-linked immunosorbent assay (ELISA) ;To obtain the percent of all subjects with E2 levels < 20 pg/mL at Week 6, quantified by liquid chromatography-mass spectrometry;To determine the percent of subjects with suppression of E2 overall (from Week 6 to Week 48) and percent with suppression at Weeks 12, 24, 36 and 48, by liquid chromatography-mass spectrometry, defined as: < 20 pg/mL in subjects treated with TOL2506 + tamoxifen; < 2.72 pg/mL in subjects treated with TOL2506 + letrozole, anastrozole, or exemestane;To obtain the percent of all subjects with no menses at Week 6 (ie, no menses after Week 5);To obtain no menses in subjects at Weeks 12, 24, 36, and 48 and overall (from Week 6 to 48) | — |
Countries
Argentina, Brazil, Mexico, Puerto Rico, United States
Contacts
Public ContactVanessa Enriquez
Tolmar Inc
Outcome results
None listed