An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT05696626

Title field or adapter rule

{'original_value': 'An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:27.883597+00:00

Published At

2026-10-29T00:00:00+00:00

Record Updated At

2026-10-29

Source Retrieved At

2026-10-31T22:18:19.086215+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Metastatic Breast Cancer"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-29", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT05696626"

protocolSection.identificationModule.officialTitle

"An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["PHASE3"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Metastatic Breast Cancer (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Treatment'], 'description': '5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day', 'name': 'Lasofoxifene in combination with abemaciclib', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Reference Therapy'], 'description': 'Fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day', 'name': 'Fulvestrant in combination with abemaciclib', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

• Lasofoxifene in combination with abemaciclib (protocolSection.armsInterventionsModule.interventions[].name)
• Fulvestrant in combination with abemaciclib (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

This index keeps the source fields it imported; it may not contain the complete original record. Verify wording and context in the linked source.