Advanced ER+, HER2-Negative Breast Cancer Clinical Trial
Official title:
A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer
| NCT number | NCT02338349 |
| Other study ID # | RAD1901-005 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | January 2015 |
| Est. completion date | April 2020 |
| Verified date | May 2020 |
| Source | Stemline Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 57 |
| Est. completion date | April 2020 |
| Est. primary completion date | September 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 exclusion criteria is provided in the protocol synopsis. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Radius Pharmaceuticals, Inc. | Waltham | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Stemline Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Dose Limiting Toxicities (DLT) | 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. | The first 28 days of treatment. | |
| Secondary | Safety and Tolerability of Elacestrant (RAD1901) | Safety and tolerability will be assessed in terms of adverse events, serious adverse events, ECG, physical examination, vital signs, and laboratory values. | Up to 30 days after the end of treatment. | |
| Secondary | Pharmacokinetics of Elacestrant (RAD1901) | Plasma concentrations of RAD1901 will be assessed at predefined intervals | Every 28 days | |
| Secondary | Anti-Tumor Effect of Elacestrant (RAD1901) | Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines. | Every 8 weeks |