TOL2506A: A Phase 3, Single Arm, Open-Label Study Evaluating Ovarian Suppression Following Three-Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination with Endocrine Therapy in Premenopausal Subjects with Hormone-Receptor–Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

  • STATUS
    Recruiting
  • sponsor
    Tolmar Inc.
Updated on 7 January 2022
endocrine therapy
hormone therapy
HER2
tamoxifen
estradiol
erbb2
anastrozole
exemestane
letrozole
her2/neu-negative breast cancer

Summary

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 aim to assess administration of TOL2506 in men with HR+ breast cancer. Study duration, for individual subjects, will be up to 57 weeks, including a Screening Period of up to 9 weeks, a Treatment Period of 48 weeks, and an End of Study Visit (Visit 8, Week 48). Eligible subjects will enter into the Treatment Period in 1 of 2 groups: those who will receive tamoxifen concurrently with TOL2506 or those who will initiate therapy with an AI (letrozole, anastrozole, or exemestane) beginning 6 weeks after the first administration of TOL2506, upon confirmation that estradiol (E2) levels of < 20 pg/mL have been achieved. After Week 12, subjects will be allowed to switch from receiving an AI to receiving tamoxifen or from tamoxifen to AI at the discretion of the Investigator. However, a switch is not permitted 28 days prior to a dosing visit. At the end of the Treatment Period, subjects will be eligible for compassionate use of TOL2506 (expanded access) until TOL2506 receives marketing approval and is commercially available.

Description

Phase 3,Single Arm,Open-Label Study Evaluating Ovarian Suppression Following 3 Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination With Endocrine Therapy in Premenopausal Subjects With Hormone-Receptor-Positive (HR+),Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Details
Condition Breast Cancer
Clinical Study IdentifierTX290231
SponsorTolmar Inc.
Last Modified on7 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Females
Able to understand the investigational nature of this study and provide written informed consent prior to the participation in the trial
Age 18 to 55, 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
Is premenopausal at the time of study entry
E2 > 30 pg/mL
Follicle stimulating hormone (FSH) < 40 IU/L
Last menstrual period within the 3 months prior to first dose of TOL2506

Exclusion Criteria

Females
Body mass index (BMI) < 18.00 kg/m2 or > 35.00 kg/m2
Breastfeeding
Life expectancy < 12 months
Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3
Unacceptable hepatic function as determined by any of the following
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 mean
History 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 msec
Prior (within 28 days prior to Day 0) 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
Prior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancer
History of treatment for osteopenia/osteoporosis
Prior or current use of drugs or supplements known to increase bone mineral density (ie, bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab, calcitonin, fluoride, strontium)
Low trauma fracture(s) occurring within 12 months prior to Screening (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 Screening
Estrogen, progesterone, or androgens within 30 days prior to Screening
Hormonal contraceptives within 30 days prior to Screening
Medications known to result in clinically important decreases in bone mass taken within 6 months prior to Screening
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 methods throughout the study
Is of childbearing potential with a positive serum pregnancy test at Screening or urine pregnancy test at Day 0
Exposure to any investigational agent within 30 days prior to the first dose of TOL2506
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