UPDATE: 12/15/13 some breaking good news about experimental drugs in ISPY2 trials.
http://www.cbsnews.com/news/new-drug-study-method-show-breast-cancer-promise/
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.
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HERE ARE THE LOCATIONS WHICH ARE CURRENTLY RECRUITING FOR I-SPY2 PARTICIPANTS:
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 | |
denise4health.wordpress.com 
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
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.
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
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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
Katie, thank you so much for keeping us posted on your journey through I-SPY2.
So glad you are able to stay on the drug….I will write you a separate email too! Denise
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. 🙂
I will contact Katie to give us an update. I know she has
now finished Chemo and is awaiting surgery.