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Association details:
| Biomarker: | ESR1 mutation |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Fablyn (lasofoxifene) (Selective estrogen receptor modulator) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
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 Breast Cancer with an estrogen receptor mutation
Excerpt:
...At least one or more of the following ESR1 point 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. ...
Trial ID:
Source:
Title:
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Excerpt:
...At least 1 or more ESR1 point mutations in the ESR1 ligand binding domain as assessed in cell- free ctDNA obtained from a blood or breast cancer tissue....
Trial ID:
More C2 evidence
Source:
Title:
Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Excerpt:
...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....
Trial ID:
Source:
Title:
Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Excerpt:
...At least one or more of the following ESR1 point mutations as assessed in cell-free circulating tumor DNA (ctDNA) obtained from a blood or tissue sample: Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N....
Trial ID:
Less C2 evidence
Source:
Title:
LBA20 - Open-label, randomized study of lasofoxifene (LAS) vs fulvestrant (Fulv) for women with locally advanced/metastatic ER+/HER2- breast cancer (mBC), an estrogen receptor 1 (ESR1) mutation, and disease progression on aromatase (AI) and cyclin-dependent kinase 4/6 (CDK4/6i) inhibitors
Published date:
09/05/2022
Excerpt:
Mean age was 60.8 yr (33-84); 83% were white, 66% had visceral disease, 71% (n=73) had measurable disease. For LAS vs Fulv, median PFS was 6.04 mos (95% CI, 2.82–8.04) vs 4.04 mos (95% CI, 2.93–6.04), P=0.138 (HR, 0.699 [95% CI, 0.445–1.125]); PFS at 12 mos was 30.7% vs 14.1%; clinical benefit rate was 36.5% vs 21.6%, P=0.12. Objective response rate for LAS vs Fulv was 13.2% vs 2.9%, P=0.12, with 1 complete response (60-week duration) and 4 partial responses (PR) in the LAS arm versus 1 PR in the Fulv arm. PFS was numerically and consistently greater with LAS vs Fulv when visceral metastasis and/or Y537S ESR1 mutation subgroups were analyzed. ELAINE 1 is the first clinical trial comparing LAS with Fulv in ESR1-mutated mBC patients with progression on CDK4/6i and demonstrating activity of a novel SERM in this setting. All clinical outcomes numerically favored LAS vs Fulv in this signal-seeking study.
Trial ID:
