Completed • Phase I • Stages III, IV • ER positive • PR positive • HER2 negative • Medical Oncology • Post-Menopausal • Interventional
The following is imported from ClinicalTrials.gov:
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
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.
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
Actual study start date:
January 20, 2015
Ages eligible for study:
18 - 999
Sexes eligible for study:
Arms and Intervention
patients must be post-menopausal women, as defined in the protocol
18 years or older
patients with histological or cytological proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced, inoperable and/or metastatic disease
part a, b, c: patients must have received no more than 2 prior chemotherapeutic regimens and at least 6 months of prior endocrine therapy
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.
prior anticancer or investigational drug treatment within the following windows:
tamoxifen therapy less than 14 days before first dose of study treatment
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
any other anti-cancer endocrine therapy less than 14 days before first dose of study treatment
any chemotherapy less than 28 days before first dose of study
any investigational drug therapy less than 28 days or 3 half-lives (whichever is longer) prior to first dose of study treatment
patients with untreated or symptomatic central nervous system (cns) metastases
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.