Tag Archives: Laura Esserman

New Clinical Trial Enables Rapid Screening of Breast Cancer Drugs

17 Mar

UCSF Chancellor Susan Desmond-Hellmann discusses the future of oncology
drug development and adaptive clinical trial design and what it means
to patients in an interview with Pharma Strategy Blog’s Sally Church.  Here are excerpts from the post:

    “What’s really neat about the I-SPY trial is that Laura Esserman, the PI of the trial, is a breast cancer surgeon here at UCSF and has added so much value to the project because she sees patients early and has a unique opportunity to offer neoadjuvant therapy.
Patients are getting their primary therapy before they get surgery, so for imaging and biomarkers – either established or exploratory – it is a fantastic opportunity. The endpoint is pathological complete response, so you can see if the tumor has disappeared or not.”

    “It’s a fantastic rapid readout model so you can get answers much more quickly in a year, including pathological specimens, along with the answers from biomarkers and imaging, which are important.
The FDA has allowed a master IND agreement for this study, so it will be possible to move agents in and out of the trial quickly. So if agent A looks promising it can be advanced quickly and more patients put on it, but if agent B looks toxic, it can be discarded quickly. It’s not just a clinical trial but a experimental trial process that gives you a rapid readout of whether the agent works or not.”

    “The hope is that you won’t wasting time and money in phase III trials, but most importantly, patients experience on that molecule. If the answer is yes on I-SPY, you then have a biomarker hypothesis for that agent and can then do a more traditional phase III trial having increased your chances of success.”

via www.pharmastrategyblog.com

Read about the i-Spy 2 adaptive clinical trial which was launched on March 17 in Washington.

Watch the video from the Biomarkers Consortium press conference:

I-Spy Trial Offers Key Insights Into Locally Advanced Breast Cancer

30 May

Dr. Laura Esserman, director of UCSF Helen Diller Family Comprehensive Cancer Center’s Breast Care Center is spearheading the development of a clinical trials model designed to accelerate and improve the efficiency with which experimental breast cancer therapies are assessed.  The strategy, which involves the use of molecular markers and MRI, utilizes “adaptive design,” in which drugs are assessed over the course of months – rather than decades – and the information used in real time to direct the course of a trial.

The series of studies are known as I-SPY (investigation of serial studies to predict therapeutic response with imaging and molecular analysis) and are being carried out  in patients with locally advanced i.e., aggressive – breast cancer. The goals of I-SPY  are to establish a clinical trials model that supports the identification of drugs targeting the molecular profiles of aggressive cancers, and to reduce the duration of the drug-assessment process from the current 15 to 20 years down to a few years.

Dr. Esserman’s team presents several findings at ASCO today.  One provocative finding shows that large, locally advanced forms of breast cancer often emerge between regular mammogram exams. These “interval” cancers present an important opportunity for doctors and patients to take advantage of neoadjuvant therapies in advance of surgery, with the hope they would be responsive. The other finding is that using molecular markers, UCSF researchers identified a subset of patients who do well regardless of how they respond to neoadjuvant treatment. They also identified a subset  with poor prognosis for whom response to neoadjuvant therapy is a good predictor of long term outcome.

Read the press release:
Continue reading