Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • (CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients who Achieve a Pathologic Complete Response

    Cancer Categories
    • Breast
    Karmanos Trial ID
    • EA1181
    NCT ID
    • NCT04266249
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II
    Principal Investigator

    Objective:

    Primary Objective:
    • To determine if 3year recurrence-free survival (RFS) is greater than 92% among clinical stages II or IIIa patients with HER2positive 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 HER2targeted therapy (and standard adjuvant endocrine therapy as appropriate).
    Secondary Objectives:

    Secondary Clinical Objectives
    • To determine 3year 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 pre-treatment clinical stage).
    • To determine 3year EFS (event-free survival) in all patients from time of study registration.
    • To evaluate safety and tolerability for all patients during the preoperative phase and for patients who attain pCR and deescalate therapy (Arm A) until the completion of post-surgery protocol assigned therapy (i.e. until the end of HP therapy).
    Secondary Correlative Objectives
    • To evaluate the association of ER status in the untreated primary tumor with pathologic response and with long term survival outcomes (including RFS, EFS, IDFS, DDFS, DRFS, RFI, OS, and Breast Cancer-specific Survival).
    • To evaluate the associations of detection of CTCs in the blood at baseline with pCR.
    • To evaluate the association of detection of CTCs in the blood at baseline, after 3 weeks of THP, after 12 weeks of THP (before surgery), after surgery before any additional therapy, and after completion of HER2targeted therapy with RFS in patients who achieve pCR or not.
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266