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Protocol Summary


Protocol No.
PSCI-20-099
Prinicipal Investigator
Truica, Cristina
Phase
N/A
Age Group
Adult
Scope
National
Secondary Protocol No.
EA1181
Title
EA1181 (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response Part 1 Component of:The CompassHER2 Trials (COMprehensive use of Pathologic response Assessment to optimize therapy in HER2-positive breast cancer).
Objective
Primary Objective
To determine if 3-year recurrence-free survival (RFS) is greater than 92% among clinical stages II or IIIa patients with HER2-positive breast cancer who achieve pCR (ypT0/is ypN0) after preoperative therapy with 12 weeks of a taxane, trastuzumab (or FDA approved biosimilar) and pertuzumab (THP x 12). Post-operatively, patients will receive standard of care adjuvant locoregional therapy, plus completion of 12 months of HER2-targeted therapy (and standard adjuvant endocrine therapy as appropriate).

Secondary Clinical Objectives
To determine 3-year IDFS (invasive disease-free survival), DDFS (distant disease-free survival), DRFS (distant relapse-free survival), RFI (recurrence-free interval), OS (overall survival) and Breast Cancer-Specific Survival in patients who achieve pCR (and by pretreatment clinical stage).

To determine 3-year EFS (event-free survival) in all patients from time of study registration.

To evaluate safety and tolerability for all patients during the pre-operative phase and for patients who attain pCR and de-escalate therapy (Arm A) until the completion of post- surgery protocol assigned therapy (i.e. until the end of HP therapy).
Applicable Disease Sites
Breast
Status
Open
Participating Institutions
Hershey Medical Center