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Monoclonal Antibodies

Arm B (trastuzumab emtansine, abemaciclib) for Breast Cancer

Phase 2
Waitlist Available
Led By Ciara C O'Sullivan
Research Sponsored by Academic and Community Cancer Research United
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 up to 5 years
Awards & highlights

Summary

This trial is testing T-DM1 with or without abemaciclib to see if it is effective in treating HER2-positive breast cancer that has spread to other parts of the body.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Duration of response
Incidence of adverse events
Overall response rate (ORR)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (trastuzumab emtansine, abemaciclib)Experimental Treatment2 Interventions
Patients receive trastuzumab emtansine IV over 90 minutes on day 1 and abemaciclib PO BID on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (trastuzumab emtansine)Active Control1 Intervention
Patients receive trastuzumab emtansine IV over 90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab Emtansine
2016
Completed Phase 3
~5730
Abemaciclib
2019
Completed Phase 2
~1800

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,003,000 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 Patients Enrolled for Breast Cancer
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,001 Total Patients Enrolled
Ciara C O'SullivanPrincipal InvestigatorAcademic and Community Cancer Research United
1 Previous Clinical Trials
68 Total Patients Enrolled
~0 spots leftby Sep 2025
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