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CHAPTER 2:

LANDSCAPE

ANALySIS OF MBC

RESEARCH

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Marc Hurlbert , Elly Cohen , Susan Colen , Stephanie Reffey , Kari Wojtanik , Musa Mayer ,
Samantha Finstad Katie McKenzie , Alison Butt , Ginny Mason , and Lynne Davies 9
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Avon Foundation for Women, BreastCancerTrials.org, Susan G. Komen, AdvancedBC.org,
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5 National Cancer Institute, California Breast Cancer Research Program, National Breast
Cancer Foundation (Australia), Inflammatory Breast Cancer Research Foundation, and
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Abstract
One part of the MBC Alliance’s mission is to advocate for and support research focusing on
extending life, enhancing quality of life, and ultimately ending death from the disease. To
inform these efforts we conducted a landscape analysis of MBC research by analyzing active
clinical trials and previously funded research grants and conducting interviews with KOLs.
Methods: We used a mixed-methods approach that included quantifying numbers of clinical
trials and funded research grants and qualitative interviews with KOLs. We captured relevant
aspects of the clinical trials and research grants for categorization and also assigned both
trials and grants into the Hallmarks of Cancer framework or Steps of Metastasis framework
[5]
[6] , where feasible. Results: Clinical trials. We identified 224 clinical trials actively recruiting
MBC patients through the NCI Physician Data Query (PDQ) dataset: 169 trials of targeted
therapies, 35 chemotherapy trials, and 20 trials focusing on specific organ sites. Most (162) of
the 169 trials of targeted therapies for MBC addressed 7 of the 10 hallmarks of cancer, including
95 trials of drugs that target sustained proliferative signaling and 27 trials of drugs that target
immune escape mechanisms. Among the 169 targeted therapy trials there were 17 phase III
trials, 54 phase II trials, and 96 phase I or phase I/II trials (note phase was not listed for 2 trials).
We also identified 118 new drugs, vaccines, or combinations thereof being tested as targeted
therapies, including 26 drugs targeting the PI3K/Akt/mTOR pathway, 20 targeting the epidermal
growth factor receptor (ErbB) family, and 10 targeting hormone receptors. Grants. A search
of 2 databases housing research grants from the majority of the cancer research funding
organizations around the world revealed 20,800 funded research grants relevant to breast
cancer, totaling $15.0 billion. Of these, we identified 2281 grants (11%), specifically relevant to
MBC totalling $1.07 billion (7.1%). The majority of MBC grants focused on either invasion (36%,
n=815) or metastatic colonization (29%, n=670); several other grants focused on multiple
steps in metastasis (10%, n=238), whereas others could not be assigned to a specific step
(13%, n=295). The grants relevant to MBC are predominantly basic research (69%), with some
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