Clinical Trial: Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS): A Randomized Phase II Study of Palbociclib With Letrozole Versus Letrozole Alone for Invasive

  • Window Phase:To evaluate the difference in anti-proliferative activity of letrozole versus tamoxifen within cohorts of hormone receptor positive breast cancer for patients with invasive lobular and ductal carcinoma. [ Time Frame: 2 years ]
    Anti-proliferative activity will be calculated by the fold-change in percent of Ki67 from baseline and Day 15 research biopsy samples.
  • Treatment Phase: To evaluate the pathologic complete response (pCR) of endocrine therapy plus palbociclib and of endocrine therapy alone in breast cancer patients diagnosed with hormone receptor positive invasive breast cancer [ Time Frame: 2 Years ]
    Pathologic response will be reported as the Residual Cancer Burden (RCB). RCB will be calculated using the MD Anderson Residual Cancer Burden calculator.


    • Original Primary Outcome:

    • To evaluate the difference in anti-proliferative activity of letrozole versus tamoxifen from baseline to research biopsy within cohorts of hormone receptor positive breast cancer for patients with invasive lobular and ductal carcinoma. [ Time Frame: 2 years ]
    • To evaluate the pathologic response of endocrine therapy plus palbociclib and of endocrine therapy alone in breast cancer patients diagnosed with hormone receptor positive invasive breast cancer [ Time Frame: 2 Years ]


    Current Secondary Outcome:

    • Overrall Response Rate [ Time Frame: 2 years ]
    • Progressive Free Survival [ Time Frame: 2 years ]
    • Overall Survival [ Time Frame: 2 years ]


    Original Secondary Outcome: Same as current

    Information By: Dana-Farber Cancer Institute

    Dates:
    Date Received: May 4, 2016
    Date Started: May 2016
    Date Completion: November 2019
    Last Updated: January 10, 2017
    Last Verified: January 2017