Palbociclib (75, 100, 125 milligram [mg]) for Estrogen Receptors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Estrogen Receptors+2 MorePalbociclib (75, 100, 125 milligram [mg]) - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing a combination of two drugs to treat estrogen receptor-positive breast cancer. The goal is to find the maximum tolerated dose and/or the recommended Phase 2 dose of the combination.

Eligible Conditions
  • Estrogen Receptors
  • Breast Cancer
  • HER2-positive Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 21 Secondary · Reporting Duration: From first dose of study drug up to Month 24

Day 28
Ratio of PK AUC24 Parameter Estimates Between Day 21 (H3B-6545) and Day 28 (H3B-6545)
Ratio of PK C24 Parameter Estimates Between Day 21 (H3B-6545) and Day 28 (H3B-6545)
Ratio of PK Cmax Parameter Estimates Between Day 21 (H3B-6545) and Day 28 (H3B-6545)
Day 28
Ratio of PK AUC24 Parameter Estimates Between Day 21 (Palbociclib) and Day 8 (Palbociclib)
Ratio of PK C24 Parameter Estimates Between Day 21 (Palbociclib) and Day 8 (Palbociclib)
Ratio of Pharmacokinetic (PK) Cmax Parameter Estimates Between Day 21 (Palbociclib) and Day 8 (Palbociclib)
Day 28
AUC(0-t): Area Under the Plasma Concentration-time Curve from Time 0 to the Last Measurable Point for Palbociclib and H3B-6545
C24: Plasma Concentration at 24 hour Post-dose for Palbociclib and H3B-6545
Cmax: Maximum Observed Plasma Concentration for Palbociclib and H3B-6545
Ratio of PK AUC24 Parameter Estimates Between Day 21 (H3B-6545) and Day 28 (H3b-6545)
Ratio of PK C24 Parameter Estimates Between Day 21 (H3B-6545) and Day 28 (H3b-6545)
Ratio of PK Cmax Parameter Estimates Between Day 21 (H3B-6545) and Day 28 (H3b-6545)
Ratio of PK Cmax Parameter Estimates Between Day 21 (Palbociclib) and Day 8 (Palbociclib)
Tmax: Time to Reach the Cmax for Palbociclib and H3B-6545
Day 28
Dose Escalation Part: MTD and/or RP2D of Palbociclib and H3B-6545
Month 24
Progression-free Survival (PFS)
Month 24
Disease Control Rate (DCR)
Objective Response Rate (ORR)
Month 24
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Month 24
Duration of Response (DoR)
Month 24
Overall Survival (OS)
Month 24
Clinical Benefit Rate (CBR)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Palbociclib + H3B-6545 (Dose Escalation and Dose Expansion)
1 of 1

Experimental Treatment

36 Total Participants · 1 Treatment Group

Primary Treatment: Palbociclib (75, 100, 125 milligram [mg]) · No Placebo Group · Phase 1

Palbociclib + H3B-6545 (Dose Escalation and Dose Expansion)Experimental Group · 2 Interventions: Palbociclib (75, 100, 125 milligram [mg]), H3B-6545 (150, 300, 450 mg) · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from first dose of study drug up to month 24

Who is running the clinical trial?

H3 Biomedicine Inc.Lead Sponsor
6 Previous Clinical Trials
520 Total Patients Enrolled
Eisai Inc.Lead Sponsor
506 Previous Clinical Trials
145,023 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have locally advanced, recurrent, or metastatic breast cancer, as per local laboratory.
You have a performance status of 0 or 1.