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SERD (Selective Estrogen Receptor Degrader)

H3B-6545 for Breast Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Eisai Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up phase 1 and 2 up to approximately 36 months

Awards & highlights

Study Summary

This trial will test the effectiveness of a new drug, H3B-6545, for women with a certain type of breast cancer.

Eligible Conditions

Breast Cancer
Tumors
No change needed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ phase 1 and 2 up to approximately 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~phase 1 and 2 up to approximately 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 1 and 2 up to approximately 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Dose-limiting Toxicities (DLTs)

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Secondary outcome measures

Area under the Plasma Concentration-time Curve from Time 0 Through the Last Measurable Point (AUC0-t) of H3B-6545

Clinical Benefit Rate (CBR)

Disease Control Rate (DCR)

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: H3B-6545 Arm 2: Phase 2Experimental Treatment1 Intervention

Group II: H3B-6545 Arm 1: Dose escalationExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

H3B-6545

2017

Completed Phase 2

~210

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eisai Inc.Lead Sponsor

515 Previous Clinical Trials

153,776 Total Patients Enrolled

16 Trials studying Breast Cancer

1,838 Patients Enrolled for Breast Cancer

H3 Biomedicine Inc.Lead Sponsor

6 Previous Clinical Trials

327 Total Patients Enrolled

Media Library

H3B-6545 (SERD (Selective Estrogen Receptor Degrader)) Clinical Trial Eligibility Overview. Trial Name: NCT03250676 — Phase 1 & 2

Breast Cancer Research Study Groups: H3B-6545 Arm 1: Dose escalation, H3B-6545 Arm 2: Phase 2

Breast Cancer Clinical Trial 2023: H3B-6545 Highlights & Side Effects. Trial Name: NCT03250676 — Phase 1 & 2

H3B-6545 (SERD (Selective Estrogen Receptor Degrader)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03250676 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please tell me how many hospitals are participating in this study?

"At the moment, this clinical trial is taking place at 17 medical facilities. Some of these are in Sarasota, Los Angeles and Goodyear with the remaining 14 centres located elsewhere. If you decide to participate in this research project, it would be best to select a location close to you to limit travel time and disruptions."

Answered by AI

Are new patients being accepted into the trial at this time?

"No, this specific trial is not recruiting patients right now. The clinical study was first posted on August 17th, 2017 and was last updated over 2 years ago on June 29th, 2022. Having said that, there are 2715 other trials with open recruitment at the moment."

Answered by AI