A Phase 3 Study of Three-Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination with Endocrine Therapy in Premenopausal Subjects with (HR+), (HER2)-Negative Breast Cancer.
- Conditions
- Health Condition 1: Z171- Estrogen receptor negative status[ER-]Health Condition 2: Z170- Estrogen receptor positive status[ER+]
- Registration Number
- CTRI/2024/07/070855
- Lead Sponsor
- Tolmar, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Able to understand the investigational nature of this study and provide written informed consent prior to the participation in the trial.
2. Age 18 to 49, inclusive.
3. Diagnosis of Stage I, II, or III HR+, HER2-negative breast cancer (ER greater than 1 percent and/or, PR greater than 1 percent, HER2-negative per ASCO CAP guidelines).
4. Is a candidate for endocrine therapy + ovarian suppression LH greater than 4 IU per L within 28 days prior to Day 1.
5. Is premenopausal as defined by
E2 greater than 30 pg per mL
follicle-stimulating hormone (FSH) less than 40 IU per L
regular menses (eg, menstrual cycle length of 21 to 35 days) Note: premenopausal status must be determined before neo or 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.
1. Body mass index (BMI) less than 18.00 kg per m2 or greater than 35.00 kg per m2
2. Breastfeeding
3. Life expectancy less than 12 months
4. Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 3
5. Unacceptable hepatic function as determined by any of the following:
a. Alanine aminotransferase (ALT) greater than or equal to 2X upper limit of normal (ULN)
b. Aspartate aminotransferase (AST) greater than or equal to 2X ULN
c. Bilirubin greater than or equal to 2X ULN
d. Alkaline phosphatase greater than or equal to 2X ULN
e. Severe hepatic impairment (Child-Pugh Class C)
6. Unacceptable renal function as determined by any of the following:
a. Creatinine greater than or equal to 3X ULN
b. Creatinine clearance less than or equal to 30 mL per minute
c. Creatinine clearance less than or equal to 60 mL per minute in subjects with bone density 1.5 standard deviations below the young adult normal mean
7. History of significantly abnormal ECG or screening 12-lead ECG demonstrating any of the following:
a. HR greater than 100 BPM
b. QRS greater than 120 msec
c. QTc greater than 450 msec
d. PR greater than 220 msec
8. Prior (within 28 days prior to Day 1) and/or concomitant use of medications known to prolong the QT/QTc interval
9. 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
10. Concomitant use of anticancer mediations other than those specified for use by the protocol
11. Prior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancer
12. History of treatment for osteopenia/osteoporosis or baseline bone mineral density Z-scoreless than or equal to -2.0
13. 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
14. 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)
15. 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)
16. 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
17. Already receiving and/or previously received GnRH analogs within 1 year before breast cancer diagnosis
18. Psychiatric, addictive, or other disorders that would preclude study compliance
19. Use of medications that may impact subject safety and/or affect the PK of the drug and hormonal assessments includin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method