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

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.

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

Study Design

Eligibility Criteria

Arms and Intervention

• Elacestrant

Inclusion criteria

• 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.

• key

Exclusion criteria

• 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.