EA1181 (CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Krishnamurthy, Jairam
Contact Information:
Shara Graalfs
+1 402-596-3151
shara.graalfs@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04266249?term=NCT04266249&rank=1
Summary
Primary Objective
(1) Determine if 3-year RFS is > than 92% among clinical stages II or III pts w/ HER2 +/ER + breast CA who achieve pCR after preop Tx w/ 12 wks of a taxane, trastuzumab et pertuzumab. PO, pts will receive SOC adjuvant locoregional Tx, plus completion of 12 mo of HER2-targeted Tx (et std adjuvant endocrine Tx for pts w/ estrogen receptor + DZ).
(2) Determine if 3-yr RFS is > than 92% among clinical stages II or III pts w/ HER2-+/ER - breast CA who achieve pCR after preop Tx w/ 12 wks of a taxane, trastuzumab et pertuzumab. PO, pts will receive SOC adjuvant locoregional Tx, plus completion of 12 mo of HER2-targeted Tx (et no adjuvant endocrine Tx for pts w/ estrogen receptor - DZ).
Secondary Clinical Objectives
(1) Determine 3-year IDFS, DDFS, DRFS, RFI, OS et Breast CA-Specific Survival in pts who achieve pCR (et by preTx clinical stage).
(2) Determine 3-year EFS in pts from time of registration.
(3) Eval safety et tolerability for pts during preop phase et for pts who attain pCR et de-escalate therapy (Arm A) until completion of postSx protocol assigned Tx.
Secondary Correlative Objectives
(1) Eval assoc of ER status in untreated primary tumor w/ pathologic response et w/ long-term survival outcomes.
(2) Eval assoc of detection of CTCs in bld at baseline w/ pCR.
(3) Eval assoc of detection of CTCs in bld at baseline, after 3 wks of THP, after 12 wks of THP (before Sx), after Sx before any additional Tx, et after completion of HER2-targeted Tx w/ RFS in pts who achieve pCR or not.
(4) Determine if breast MRI radiomics signatures reflecting intratumor heterogeneity et microenvironment at baseline are predictive of pCR.
(5) Eval assoc betw TILs in baseline tumor et 3-yr RFS in all pts.
(6) Eval assoc betw TILs in baseline tumor w/ pCR in all pts.
Exploratory Clinical Objectives
(1) Determine 3-yr RFS, IDFS, DDFS, DRFS, RFI, OS et Breast CA-Specific Survival in pts who do not achieve pCR (et by preTx clinical stage).
(2) Determine pathologic response to THP neoadjuvant Tx, as assessed by RCB.
(3) Determine assoc betw RCB et all described STEEP criteria outcomes.
(4) Determine FNR of limited staging procedures (defined as SLNB plus removal of clipped node) in pts who undergo such procedures w/ a planned ALND.
(5) Determine axillary pCR rates as a function of burden of DZ as determined on pre-Tx US et axillary staging technique.
Exploratory Correlative Objectives
(1) Evaluate assoc betw plasma tumor cell-free DNA (cfDNA) tumor-specific mutations (baseline et after Tx w/ pathologic response et long-term outcomes.
(2) Eval assoc betw TILs in baseline tumor w/ pathologic response et long-term outcomes, et residual tumor w/ long-term outcomes.
(3) Eval assoc betw immune activation gene signatures in baseline tumor et pathologic response et outcomes.
(4) Eval assoc of intrinsic subtype at baseline with outcomes.
(5) Detemine freq of change in intrinsic subtype betw preTx tumor specimen et residual DZ at time of Sx et to eval any assoc w/ survival.
(6) Eval assoc betw DNA copy number, DNA mutations, RNA expression et protein expression in baseline tumor et changes from baseline to post-THP therapy w/ pathologic response et long-term outcomes.
(7) Determine if functional DCE-MRI markers reflecting tumor vascularity at baseline are predictive of Tx outcome.
(8) Determine if breast MRI radiomics signatures at post-Tx/preSx are predictive of Tx outcome.
(9) Investigate performance of combined modeling incorporating radiomics et other prognostic markers to predict Tx response in women with HER2+ breast CA.
(10) Eval assoc betw TILs in baseline tumor with pCR et 3-yr RFS in pts w/ HER2 +/ER + breast CA et in pts w/ HER2 +/ER - breast CA, separately.