Condition: Locally Advanced or Metastatic Breast Cancer · Sponsor: Sermonix Pharmaceuticals Inc.
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).
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Mayo Clinic Arizona | Phoenix, Arizona, United States | — |
| Yuma Regional Medical Center (JIT) | Yuma, Arizona, United States | — |
| City of Hope Comprehensive Cancer | Duarte, California, United States | — |
| Compassionate Care Research Group | Fountain Valley, California, United States | — |
| UCSF Cancer Center | San Francisco, California, United States | — |
| Rocky Mountain Cancer Centers | Longmont, Colorado, United States | — |
| Mayo Clinic Florida | Jacksonville, Florida, United States | — |
| Miami Cancer Institute | Miami, Florida, United States | — |
| Ocala Oncology Center (JIT) | Oscala, Florida, United States | — |
| Florida Cancer Specialists | Tallahassee, Florida, United States | — |
| The Bond Clinic Cancer & Research Center. | Winter Haven, Florida, United States | — |
| Emory University | Atlanta, Georgia, United States | — |
+ 39 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03781063