Advanced ER+, HER2-Negative Breast Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of elacestrant (RAD1901) in patients with advanced ER+, HER2-negative breast cancer.
Detailed description
The primary objective is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of elacestrant in patients with advanced ER+HER2-negative breast cancer. The secondary objectives of this study are: * To assess the safety and tolerability of elacestrant * To evaluate the pharmacokinetics (PK) of elacestrant * To evaluate the preliminary anti-tumor effect of elacestrant
Interventions
DRUGElacestrant
Sponsors
Stemline Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Patients must be post-menopausal women, as defined in the protocol 2. 18 years or older 3. Patients with histological or cytological proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced, inoperable and/or metastatic disease 4. Part A, B, C: Patients must have received no more than 2 prior chemotherapeutic regimens and at least 6 months of prior endocrine therapy 5. Part D: Patients may have received up to 1 previous line of chemotherapy and must have previously received 2 or more lines of endocrine therapy for advanced/metastatic breast cancer as a single agent or in combination. Patients must have received fulvestrant as one of the previous lines of endocrine therapy and have had documented progression while on, or within 1 month after the end of, fulvestrant therapy for advanced/metastatic breast cancer. Patients must have received prior treatment with a CDK4/6 inhibitor Note: This list is not complete. Further inclusion criteria is provided in the protocol synopsis. Key
Exclusion criteria
1. Prior anticancer or investigational drug treatment within the following windows: 1. Tamoxifen therapy less than 14 days before first dose of study treatment 2. Part A, B and C: Fulvestrant therapy less than 90 days before first dose of study treatment. Part D: Fulvestrant therapy less than 42 days before first dose of study treatment 3. Any other anti-cancer endocrine therapy less than 14 days before first dose of study treatment 4. Any chemotherapy less than 28 days before first dose of study 5. Any investigational drug therapy less than 28 days or 3 half-lives (whichever is longer) prior to first dose of study treatment 2. Patients with untreated or symptomatic central nervous system (CNS) metastases 3. Patients with endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding or cysts Note: This list is not complete. Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicities (DLT) | The first 28 days of treatment. | To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of Elacestrant (RAD1901), the incidence of Dose Limiting toxicities (DLTs) will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Elacestrant (RAD1901) | Up to 30 days after the end of treatment. | Safety and tolerability will be assessed in terms of adverse events, serious adverse events, ECG, physical examination, vital signs, and laboratory values. |
| Pharmacokinetics of Elacestrant (RAD1901) | Every 28 days | Plasma concentrations of RAD1901 will be assessed at predefined intervals |
| Anti-Tumor Effect of Elacestrant (RAD1901) | Every 8 weeks | Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines. |
Countries
United States
Outcome results
None listed