Spots Global Cancer Trial Database for Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor (REPLOT Trial)

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Trial Identification

Brief Title: Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor (REPLOT Trial)

Official Title: Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor (REPLOT Trial)

Study ID: NCT06408168

Conditions

Hormone Receptor-positive Human Epidermal Growth Factor 2-negative

Metastatic Invasive LObular Carcinoma

Interventions

Fulvestrant

Repotrectinib

Study Description

Brief Summary: To find out if the combination of repotrectinib and fulvestrant can control the disease in participants with metastatic invasive lobular carcinoma.

Detailed Description: Primary Objectives • To evaluate the 6-month progression free survival (PFS) of repotrectinib with or without fulvestrant in HR+ HER2- mILC patients who received a prior ET in combination with CDK4/6i Secondary Objectives * To evaluate the 12-month PFS and median PFS (mPFS) of repotrectinib with or without fulvestrant in HR+ HER2- mILC patients who received a prior ET in combination with CDK4/6i * To evaluate the overall response rate (ORR) of reporectinib with or without fulvestrant in HR+ HER2- mILC patients who received a prior ET in combination with CDK4/6i * To assess the clinical benefit rate (CBR), median duration of response (mDOR), and median overall survival (mOS). * To evaluate the safety and tolerability of repotrectinib alone and in combination with fulvestrant, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 Exploratory/Correlative Objectives * To explore response to repotrectinib based on ROS1 and P120 expression by IHC * To explore if changes in serum thymidine kinase 1 activity (TKa) between baseline and C1D15 correlates with response * To explore whether changes in circulating tumor DNA (ctDNA) levels between baseline and C1D15 predict response to repotrectinib * To correlate whole exome sequencing (WES) and RNA sequencing (RNAseq) findings with response (or lack of) to repotrectinib * To explore changes in the tumor microenvironment (TME) composition using mIF in response to repotrectinib