Randomized Open Label Clinical Study of the Targeted Therapy Palbociclib to Treat Metastatic Breast Cancer

  • End date
    Feb 28, 2026
  • participants needed
  • sponsor
    Alliance Foundation Trials, LLC.
Updated on 27 January 2021
endocrine therapy
neutrophil count
hormone therapy
liver metastasis
targeted therapy
stage iv breast cancer
invasive breast cancer
metastatic cancer


The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.


Subjects will be randomized into one of two treatment arms following minimum of 4 and maximum of 8 cycles of induction treatment with anti-HER2 therapy. Arm A subjects will receive the experimental therapy, palbociclib, in addition to their current anti-HER2 therapy and endocrine therapy. Arm B subjects will continue to receive the anti-HER2 therapy. It is expected that the addition of palbociclib to the first-line treatment of HER2 disease will delay the onset of therapeutic resistance and ultimately prolong the survival of patients with metastatic breast cancer. The study is designed to treat the subset of patients with HER2+ disease who are also hormone receptor positive (HR+). It is also expected that palbociclib will modulate the endocrine resistance in HER2+/HR+ disease and potentiate the benefits of anti-HER2 therapy. Lastly, the current study includes a comprehensive molecular characterization of the disease at study entrance which will allow us to investigate the benefits of palbociclib in subsets of HER2+/HR+ disease such as PIK3CA mutant.

Condition Estrogen Receptor Positive Breast Cancer, ER+ Breast Cancer, Her 2 Positive Breast Cancer, estrogen receptor-positive breast cancer
Treatment Trastuzumab, Letrozole, anastrozole, exemestane, fulvestrant, Pertuzumab, Palbociclib
Clinical Study IdentifierNCT02947685
SponsorAlliance Foundation Trials, LLC.
Last Modified on27 January 2021


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