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What role do you • Clinical utility of CTCs and ctDNA remains unproven, but they are useful tools for
see for markers or the research setting and can be prognostic in some clinical settings, however we
circulating tumor cells still do not understand whether they are biologically useful
(CTCs)? • What do CTCs/ctDNA represent? Are they from primary tumors? From
metastatic tumors? Both?
• The source of these cells or ctDNA now in circulation is unknown

Can you describe Endpoints
the challenges • New clinical trial designs are needed that address endpoints beyond tumor
in designing and shrinkage and the RECIST scale; consider time to secondary metastasis or time
conducting clinical to first metastasis in early breast cancer
trials for MBC? • Consider how many patients had lesion growth or shrinkage, how many had
a secondary metastatic site develop; and consider progression-free survival
studies in early metastatic disease
• Quality of life measures need to be a part of all clinical trials

Drugs/experimental therapeutics
• Preclinical studies show that several agents can prevent or slow metastasis; need
to translate these findings into clinical trial design
• Current drugs in solid tumors do not work very well; there is too much industry
influence driving clinical trials, which has trickled down into academia;
progression-free survival and other endpoints are meaningless if the drugs do
not significantly extend life span and quality of life

• There is duplication in clinical research; for example, too many “me-too” drugs
are being developed in industry (e.g., PI3K inhibitors)

Recruitment for MBC trials in the US is challenging; patients need easier access
to trial information—should review the steps the United Kingdom took to triple
the number of cancer patients on trials from 4% to 12%

• In general, screening is not aimed at early detection of metastasis, largely
because in the past there were few treatment options; it is worth reconsidering
this approach

• There are too many solo investigators who design, execute, complete and
publish single-center phase II trials; most likely this is required for promotion of
clinical investigators; the reward system in academia needs to change to reward
multicenter, multi-investigator, collaborative phase II trials

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