I-SPY2 Clinical Trial for Newly Diagnosed Breast Cancer Patients

UPDATE:  12/15/13   some breaking good news about experimental drugs in ISPY2 trials.


If you have been newly diagnosed with breast cancer, you are overwhelmed.  Not only are you frightened for your life and health,  afraid for your family and loved ones, but you have to make many huge medical decisions in a relatively short period of time.  The time when I was newly diagnosed before my treatment plan was is in place was the worst time.  One thing to consider when newly diagnosed is to see if you qualify for a clinical trial, which is a rigorously controlled test of  new drug(s) or procedures.

Katie Brown from Bainbridge Island, Washington wrote and told me about the Clinical Trial she is participating in for her diagnosis of breast cancer.  The Clinical Trial is called                I-SPY2 and is currently recruiting patients from across the country in various locations (see below).

Terry Maas, an Oncology Research Nurse Coordinator at Swedish Cancer Institute in Seattle, Washington where Katie is receiving treatment, encourages women to look at these Clinical Trial websites to allow yourself time to absorb the information, educate yourself by identifying and understanding new terminology, while formulating questions you may have, so you can further discuss them with your Health Care Team.  Ms. Maas recommends reviewing www.ISPY2.org and http://clinicaltrials.gov/show/NCT01042379 to learn more about this I-SPY2 Clinical Trial.


I-SPY2 will help get investigational drugs to the market much more quickly.  Katie is undergoing standard chemotherapy treatment for her tumor, Taxol with Herceptin, then on to Adriamycin and Cytoxan with Herceptin.  In addition, a yet unnamed drug is being added.  The trial drug she is on is MK2206 which is in pill form and for her is taken as part of the Taxol protocol.   Katie’s tumor shrunk by one-third after only two chemo treatments!

This from the www.ISpy2.org website:

I-SPY 2 is a clinical trial for women with newly diagnosed locally advanced breast cancer

Today most women with breast cancer receive standard chemotherapy.  We know that some breast cancers respond well to standard chemotherapy but some do not.  The I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) is a clinical trial for women with newly diagnosed locally advanced breast cancer to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone before having surgery.  The treatment phase of this trial will be testing multiple investigational drugs that are thought to target the biology of each participant’s tumor.  The trial will use the information from each participant who completes the study treatment to help decide treatment for future women who join the trial.  This will help the study researchers learn more quickly which investigational drugs will be most beneficial for women with certain tumor characteristics.  The I-SPY 2 TRIAL will test the idea of tailoring treatment by using molecular tests to help identify which patients should be treated with investigational drugs.  Results of this trial may help make investigational drugs available to more women in the future.



Please refer to this study by its ClinicalTrials.gov identifier: NCT01042379

Contact: Meredith Buxton, MPhil, MPH 415-353-7357 meredith.buxton@ucsfmedctr.org
Contact: Donya Bagheri, MS, DABT 650-691-4400 ext 116 dbagheri@ccsainc.com

United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Valerie Caterinicchia, RN, BSN     205-934-5367     val7@uab.edu
Principal Investigator: Andres Forero, MD
United States, Arizona
Mayo Clinic – Scottsdale Active, not recruiting
Scottsdale, Arizona, United States, 85259
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Amy S Bauland     520-694-0859     abauland@azcc.arizona.edu
Principal Investigator: Rebecca Viscusi, MD
United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093-0698
Contact: Cynthia Meyer     858-822-6575     cjmeyer@ucsd.edu
Contact     858-822-5354     CancerCTO@ucsd.edu
Principal Investigator: Anne Wallace, MD
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Debu Tripathy, MD     323-865-3900     Tripathy@usc.edu
Contact: Kristy Watkins, RN     323-865-0452     Watkins_K@ccnt.usc.edu
Principal Investigator: Debasish Tripathy, MD
University of California San Francisco (UCSF) Recruiting
San Francisco, California, United States, 94115
Contact     877-827-3222
Principal Investigator: Amy Jo Chien, MD
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Tessa Mcspadden     720-848-0609     tessa.mcspadden@ucdenver.edu
Principal Investigator: Anthony Elias, MD
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Minetta Liu, MD     202-444-3677     Liumc@georgetown.edu
Principal Investigator: Claudine Isaacs, MD
United States, Georgia
Emory University Active, not recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60453
Contact: Jean Gibson     773-834-2167     jgibson@medicine.bsd.uchicago.edu
Principal Investigator: Rita Nanda, MD
Loyola University Recruiting
Maywood, Illinois, United States, 60153
Contact: Kathy Czaplicki     708-327-3322     kczapli@lumc.edu
Contact: Agnes Natonton     708-327-2237     anatont@lumc.edu
Principal Investigator: Kathy Albain, MD
United States, Kansas
University of Kansas Active, not recruiting
Westwood, Kansas, United States, 66205
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Charlotte Smith     612-625-9498     Smit4652@umn.edu
Principal Investigator: Doug Yee, MD
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact     507-538-7623
Principal Investigator: Judy C Boughey, MD
United States, Oregon
Oregon Health & Science Institute (OHSU) Recruiting
Portland, Oregon, United States, 97239
Contact: Deirdre Nauman, BSN,CCRP     503-494-3078     naumand@ohsu.edu
Principal Investigator: Stephen Y Chui, MD
United States, Pennsylvania
University of Pennsylvania (U Penn) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Luke Velders     215-615-6821     Luke.Velders@uphs.upenn.edu
Principal Investigator: Angela DeMichele, MD
United States, Texas
University of Texas, Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-9155
Contact: Barabara Staves, BS     214-648-1988     barbara.staves@utsouthwestern.edu
Contact: Vanessa Tagoe, MA, CCRC     214-648-7020     Vanessa.Tagoe@utsouthwestern.edu
Principal Investigator: David Euhus, MD
University of Texas, M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77230-1439
Contact: Cara Dunlap, RN     713-745-8748     CLDunlap@mdanderson.org
Principal Investigator: Stacy Moulder, MD, MSCI
United States, Virginia
Inova Health System Recruiting
Falls Church, Virginia, United States, 22042
Contact: Alyssa Bruflodt     703-776-3565     Alyssa.Bruflodt@inova.org
Principal Investigator: Kirsten Edmiston, MD, FACS
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Barry Boatman, RN     206-215-3086     CancerResearch@swedish.org
Principal Investigator: Hank Kaplan, MD
Principal Investigator: Erin Ellis, MD
University of Washington Recruiting
Seattle, Washington, United States, 98115
Principal Investigator: Larissa Korde, MD, MPH


  1. Good job Denise! Thank you for getting the word out. I’m convinced these trials will save a lot of lives. I’ll keep you informed on my progress. Hope you’re staying well and enjoying this beautiful new season. Blessings, Katie

    Sent from my iPad

  2. Hi Denise, Great entry. I am in the MM 121 phase 2 trial. I am doing that with Taxol. I think that you really have to do a lot of research on your own to find out what the potential side effects are of this drugs. I am glad I chose to participate, but wish I knew more so I could prepare myself. My tumors have shrunk and my surgeon used the term lumpectomy last time I saw her. I have only one dose left before I move on to Adriamycin Cytoxin. May 30 is my last day of chemotherapy and I am so looking forward to it. Although, I will say, the experience has not been as bad as I imagined.

  3. Hi Denise, Thanks for writing this post.  You are so determined to help others that surely you will be blessed many times over. If it weren’t for your blog, I and countless others would not be aware what it is like to have cancer and what cancer patients go through, not to mention the progress, however slow, is being made to treat the disease.I am increasingly amazed at the new information about research that has come out since you were first diagnosed with cancer. I only wish it would move faster. Life has so many challenges and as I get older, I wonder how we carry on.  I never knew life could be so difficult in so many ways. Keep up the great work you are doing to help others understand and cope.  You are a very special person and I am very proud to have you for a niece. Love, Auntie M


  4. Hi Denise, I just finished another round of chemo. When I arrived at Swedish yesterday I was initially told because of another woman who had complications from taking MK2206, the trial had decided to discontinue the drug. Both my oncologist and I were very disappointed, since I have done so well on the drug. Well…. It turns out the poor woman who had the complications, and did unfortunately die, was being treated for a completely different type of cancer and was being administered a much higher dose. My oncologist did say I was lucky I had already received 2/3’s of the MK2206. When I got down to the chemo lab one of the research nurses came running in and told me the powers in charge of the trial had decided to allow all of the women in the I SPY 2 trial to continue being allowed to receive MK 2206. I was relieved and happy. I also asked Dr. Erin Ellis, my oncologist why I was not going to be given Herceptin with my Adriamyacin and Cytoxan. I don’t know if I told you, after the A/C treatment I will have surgery and then I have to return for 9 months every other week for just the Herceptin. She told me there were several studies out about heart damage if you’re given Herceptin at the same time as the A/C infusions. Just wanted to keep you updated and I hope I’m not bugging you with all this info about me. Hope you’re staying well and once again thank you for all you do. Katie

    Sent from my iPad

  5. Hi. Just found your blog by searching up MK2206. I was just told today that that will be my extra medicine in the I spy2 trial. I start tomorrow. I do have triple negative breast cancer but am nervous now about hearing someone has died from this medication. 😦 Hoping Katie is doing well and would so like to hear if she had any additional side effects with MK2206. Thanks! Will now check out the rest of your blog. 🙂

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