A Study of Lerociclib in Participants With Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT05085002|
Recruitment Status : Not yet recruiting
First Posted : October 20, 2021
Last Update Posted : November 24, 2021
Information provided by (Responsible Party):
This is a multicenter, single-arm, open-label study to evaluate the safety and efficacy of lerociclib in combination with standard endocrine therapy in female or male participants with HR+/HER2- MBC. The study population will consist of either newly diagnosed, treatment naïve participants with HR+/HER2- MBC (1L population) and participants with HR+/HER2- MBC who have already progressed on first line endocrine therapy such as tamoxifen, anastrozole, or letrozole (2L population). All premenopausal or perimenopausal female participants, and all male participants, must be receiving goserelin for at least 28 days prior to entering the study and will remain on goserelin throughout the study, in accordance with the prescribing information and according to the study site's standard practice.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Breast Cancer||Drug: Lerociclib + Letrozole or Fulvestrant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study to Evaluate the Safety and Efficacy of Lerociclib in Participants With Advanced Breast Cancer|
|Estimated Study Start Date :||November 2021|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||May 2026|
|Lerociclib + letrozole or fulvestrant||
Drug: Lerociclib + Letrozole or Fulvestrant
All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
Primary Outcome Measures :
- Incidence of AEs and SAEs [ Time Frame: Up to 4.5 years ]The number and percentage of participants experiencing any TEAE and serious TEAE will be tabulated by line of therapy.
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