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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04227327
Other study ID # HERMIONE-7
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date January 7, 2020
Est. completion date December 2023

Study information

Verified date April 2023
Source University of Milano Bicocca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The HERMIONE-7 trial is a phase II, single-arm, open-label, multicenter study in HR+, HER2- advanced breast cancer patients who have received HD-FUL as first-line endocrine treatment for their metastatic disease. Patients will receive aromatase inhibitors plus Abemaciclib.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Abemaciclib
Abemaciclib will be administered orally at 150 mg twice daily
Aromatase Inhibitors
Letrozole 2,5 mg daily or Anastrozole 1 mg daily

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Sponsors (1)

Lead Sponsor Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical benefit rate (CBR) in HD-FUL pre-treated MBC patients treated with Abemaciclib + aromatase inhibitors (letrozole or anastrozole) CBR is defined as the proportion of patients in Complete Response (CR), Partial Response (PR) or with Stable Disease (SD) >= 24 weeks (as defined by RECIST 1.1 Criteria) evaluated at 6 months from treatment initiation. At 6 months from treatment initiation
Secondary Time To Progression (TTP) TTP is defined as the time from date of start of treatment to the date of event, i.e. the first documented progression or death due to underlying cancer Through study completion, an average of 42 months
Secondary Overall Response Rate (ORR) ORR is defined as the proportion of patients with best overall response of CR or PR) according to RECIST 1.1. Through study completion, an average of 42 months
Secondary Duration of Overall Response (DoOR) DoOR is defined as the time of initial response until documented tumor progression Through study completion, an average of 42 months
Secondary Duration of Clinical Benefit (DoCB) DoCB is defined as the time of initial CB until documented tumor progression Through study completion, an average of 42 months
Secondary To assess the safety profile of Abemaciclib in association with aromatase inhibitors (letrozole or anastrozole) The Medical Dictionary for Regulatory Activities (MedDRA) Version 19.0 (or higher) will be used when reporting AEs by MedDRA terms. The MedDRA Lower Level Term will be used in the treatment-emergent computation. Treatment-emergent adverse events will be summarized by System Organ Class (SOC) and by decreasing frequency of Preferred Term within SOC. Through study completion, an average of 42 months
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