SNPMiner Trials (Home Page)
Report for Mutation L536P
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 An Open-Label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Pre- and Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2− Breast Cancer With an ESR1 Mutation
This is an open label, randomized, multicenter study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2− breast cancer with an acquired ESR1 mutation and who have disease progression on an aromatase inhibitor (AI) in combination with a cyclin dependent kinase (CDK) 4/6 inhibitor. The primary objective is to evaluate the progression free survival (PFS) of 5 mg lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2−) breast cancer with an estrogen receptor 1 (ESR1) mutation. The secondary objectives are to evaluate: 1. Clinical benefit rate (CBR) and Objective Response Rate (ORR) 2. Duration of response 3. Time to response 4. Overall Survival (OS) 5. Pharmacokinetics of lasofoxifene 6. Quality of life (QoL): Quality of Life (QoL): vaginal assessment scale (VAS) and vulvar assessment scale (VuAS) questionnaires 7. Safety of lasofoxifene 8. Response to various ESR1 mutation (Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N).
NCT03781063 Locally Advanced or Metastatic Breast Cancer Drug: Lasofoxifene Drug: Fulvestrant MeSH:Breast Neoplasms
HPO:Breast carcinoma Neoplasm of the breast
The secondary objectives are to evaluate: 1. Clinical benefit rate (CBR) and Objective Response Rate (ORR) 2. Duration of response 3. Time to response 4. Overall Survival (OS) 5. Pharmacokinetics of lasofoxifene 6. Quality of life (QoL): Quality of Life (QoL): vaginal assessment scale (VAS) and vulvar assessment scale (VuAS) questionnaires 7. Safety of lasofoxifene 8. Response to various ESR1 mutation (Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N). --- Y537S --- --- Y537C --- --- D538G --- --- E380Q --- --- S463P --- --- V534E --- --- P535H --- --- L536H --- --- L536P ---
At least one or more of the following point ESR1 mutations as assessed in cell-free circulating tumor DNA (ctDNA) obtained from a blood (plasma) or tissue sample: Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N. --- Y537S --- --- Y537C --- --- D538G --- --- E380Q --- --- S463P --- --- V534E --- --- P535H --- --- L536H --- --- L536P ---
Primary Outcomes
Description: PFS is defined as the interval from the date of randomization to the earlier date of first documented radiographic progression or death due to any cause
Measure: Progression-Free Survival (PFS) Time: through study completion, an average of 1 yearSecondary Outcomes
Description: CBR is defined as the percentage of all subjects with a complete or partial response; or stable disease for >/=24 weeks.
Measure: Clinical Benefit Rate (CBR) Time: through study completion, an average of 1 yearDescription: ORR is defined as the percentage of subjects with either a complete response (CR) or a partial response (PR) as assessed by the RECIST 1.1 criteria.
Measure: Objective Response Rate (ORR) Time: through study completion, an average of 1 yearDescription: OS is defined as time from randomization to death due to any cause.
Measure: Overall Survival (OS) Time: through study completion, an average of 1 yearDescription: The type, severity (graded by Common Terminology Criteria for Adverse Events [CTCAE version 5.0]), course, duration, seriousness, and relationship to study treatment will be assess at each visit
Measure: Incidence of Adverse Events (AEs) and Serious AEs Time: through study completion, an average of 1 year