Archive for May, 2012

From the Program Director

New Website for BreastCancerTrials.org!

Dear BCT Readers:

In our last issue of talking About Trials, I hinted about upcoming changes to BCT. Now, I’m happy to report, the new BCT is here! Sporting a fresh “look and feel,” the site is easier to navigate, allows users to share trials, and features our new QuickViews: easy access to groups of trials sorted by tumor type or trial category. If you haven’t been to the new site, please visit. We’d love to know what you think.

Our feature article this issue is about how Phase I treatment trials are changing in the era of personalized medicine. The article should be interesting to all patients, but especially to those with metastatic disease. I want to thank Jennifer Wheler, MD,  from MD Anderson Cancer Center in Houston, TX, Pam Munster, MD,  from University of California, San Francisco, and Suzanne Hebert, a patient currently enrolled in a Phase I trial, who each generously shared their insights and experiences.

I am frequently asked how we select trials for BCT. And given Suzanne’s comment that she would not have expected to find her Phase I trial on BCT, this seems like an opportune time.  All of our trials originate in ClinicalTrials.gov, which we access through a license with the National Cancer Institute (NCI). Every week NCI sends us information about newly opened (or closed) breast cancer studies. On occasion, we miss studies that are not exclusively for breast cancer patients, but open to patients with a variety of tumors including breast (solid tumor trials). If you learn of a solid tumor trial that is not on BCT, please let us know. Once we confirm that it is enrolling breast cancer patients, we will obtain its trial information from NCI. With your help, we can continue to ensure that BCT’s trial registry is accurate and up-to-date.

Sincerely,
The BCT Team

The BCT Team: (from L to R): George Weis, Bethany Hornthal, Tom Bechtold, Elly Cohen, Susan Colen, Laurie Isenberg, Erin McCreary, Sue Rochman. Not pictured: Debby Hamolsky and Jeff Belkora

May 16, 2012 at 10:20 pm Leave a comment

Phase I Clinical Trials – A Changing Paradigm

Phase I clinical trials for cancer have traditionally focused on testing the safety of new drugs, enrolling only patients in advanced stages of disease who were counseled not to expect any personal benefit. As more targeted or “personalized” therapies emerge from the laboratory, the design of Phase I clinical trials is evolving to allow investigators to begin to look more closely at efficacy (how well a tumor is responding to therapy). In addition, investigators are testing not only new drugs but those that the FDA has approved for different types of cancer, which are now being studied in combination with previously approved breast cancer therapies.

Jennifer Wheler, MD

“The first thing I tell my patients is that Phase I trials come in all shapes and sizes,” says Jennifer Wheler, MD, Assistant Professor in the Department of Investigational Cancer Therapeutics, Division of Cancer Medicine at the University of Texas, MD Anderson Cancer Center, in Houston, Texas. “With targeted therapies the old way of running clinical trials with Phase I, Phase II and Phase III components is becoming outdated,” she adds. According to Wheler, the important work now is to profile a patient’s tumor so that targeted therapies can be tested on individuals and personalized to the aberrations that are apparent in their disease.

“For instance, the PI3K pathway is an important aberration in breast cancer,” says Wheler, “and we’ll probably find that a significant proportion of breast cancer patients have an aberration in this pathway. This essentially means that targeting it with a new drug would be a useful thing.”

Wheler is currently lead investigator for a trial at MD Anderson (similar to Bolero-2, which was a Phase III trial for advanced breast cancer patients) that has enrolled over 100 cancer patients to test Anistrozole (Arimadex®), an anti-hormone therapy agent, in combination with Everolimus (Afinitor®), a therapy targeted to cellular growth. In this particular study, if a patient develops resistance to either of the two drugs, then the strategy is to add a third drug to try and overcome the resistance. This means that treatment in this Phase I trial is truly tailored to both a patient’s tumor biology and her response to therapy.

Pam Munster, MD

“Many patients will never consider a Phase I trial because they believe the drug being tested will be in such an early stage of its development that they will not benefit from taking it,” says Pam Munster, MD, Director, Early Phase Clinical Trials Unit and Leader, Developmental Therapeutics Program, at the University of California San Francisco, Helen Diller Family Comprehensive Cancer Center. “But we really try to make every effort to select the right drugs for patients, so they at least have a chance of a good response.”

Both Munster and Wheler assert that early studies involving new drugs are always carefully designed to monitor safety. The first patients admitted into a Phase I trial receive a very small dose of the drug. Only when investigators are satisfied that the side effects are not harmful, is the dose gradually increased or “escalated.” This is done until they have identified the highest dose that can be tolerated without side effects.

“We look very closely at the preclinical safety studies,” says Munster. “And we will take patients off a study as soon as we find out it is not helpful to her.”

For a patient, a Phase I trial may be the best chance she has to experience a new drug. This is because a patient accepted onto a Phase I trial is sure to receive a new drug. Someone who waits until the drug is tested in a Phase III trial may either not be eligible for the trial because of number of prior treatments or may end up randomized to a control group receiving the standard treatment of care or sometimes a placebo. There are no control groups in Phase I trials; everyone receives the drug.

The patients Munster enrolls in her trials tend to be those at the end stage of their disease who come onto a Phase I trial as a last resort. She explains that these individuals often have severely compromised overall health and are frequently very sick, which means it is hard to truly test the efficacy of the targeted drugs.    She believes that she would see better responses in patients whose disease had not progressed so far already.

“We would like to see patients at least considering a Phase I trial earlier in their treatment history,” says Munster. “In particular, now because there is more potential for her to personally benefit from therapy if appropriately selected.”

May 16, 2012 at 10:19 pm 1 comment

Personal Stories: Suzanne Hebert

Suzanne Hebert has undergone many treatments, including surgeries and chemotherapies, to fight off her stage IV breast cancer. She was diagnosed with the advanced stage cancer at age 39, 7 1/2 years ago; it was only when she started treatment in a Phase I clinical trial at MD Anderson in July 2011 that she saw some respite from the disease.

Tell me why you decided to enroll in a Phase I Clinical trial?
I had already been in a couple of Phase III trials but I had never considered a Phase I. I think there are a lot of preconceptions about clinical trials in general and about Phase I in particular. Like many patients, I just crossed it off my list. Then my doctor suggested that I go and see someone at the Clinical Center for Targeted Therapy, MD Anderson’s Phase I Clinical Trials clinic. I ended up talking with Dr. Jennifer Wheler and she offered me a trial, which sounded great. She carried out some tests and decided that the drug I was going to be taking, Everolimus (Afinitor®), might have a good chance of working on my cancer. So I agreed to enroll.

Were you surprised at some of what you learned from Dr. Wheler about clinical trials?
Yes, I was. One of the first things I learned was that the drug I would be getting was already FDA approved for kidney and brain cancer; it just wasn’t approved for breast cancer. I had always thought that a Phase I trial would involve an unproven drug and that I would receive a dose escalation for safety reasons. I never considered that in Phase I, I would be getting a drug that was already approved. Knowing that I was not going to be one of the first to take the drug put my mind at ease. The other thing I learned was that I was eligible for solid tumor trials whereas I had always been researching breast cancer trials. This trial was open to people with varying types of cancer. So I would not have even have come across it if Dr. Wheler had not told me about it.

Editor’s Note: BCT includes solid tumor trials open to different types of solid tumors including breast cancer. You can learn more about these and other trials for metastatic breast cancer here.

Do you feel like you are carefully monitored on the trial?
Yes, definitely. I see the doctor once a month and have scans every two to three months. I am very closely watched.

What effect did the drug being tested have on your tumor?
The first scan showed that my tumor had shrank by 20 percent. Since then it has been stable, which in the world of Stage IV breast cancer is okay.

Is the trial still going on?
Yes, it is. And hopefully soon the FDA will approve Afinitor for breast cancer patients so that people will be able to get the drug, not necessarily in a trial. Their doctor will be able to prescribe it for them.

Do you talk to any other patients who are on the trial?
Through different breast cancer websites, I have met a woman who is on the trial and there are a couple of other people I’ve met online. I like to keep track with what’s going on with everyone.

Was it easy for you to enroll on the trial?
I just had to sign my name and take a couple of tests. All three trials I’ve been in, I have found very easy to sign up for.

What would you say to people thinking about a Phase 1 trial?
I would say to keep an open mind about trials, and be aware that there is a lot of false information out there. If you take the extra step to do the research for yourself, it might be worth it. For me, it was a good experience. Unfortunately, your doctor is not going to come to you and say, here is the perfect trial. Patients must do the research themselves, which sometimes can be hard with all they are going through. The other thing I would say is that you can always drop out of a trial. People think they are tied in, but if you are not happy with anything at all, you can always leave.

May 16, 2012 at 10:18 pm 3 comments

Calendar/Events May 2012

Understanding the Importance of Clinical Trials: What You Need to Know
Free teleconference; registration required
May 18, 1:30-2:30 pm, EST

Pregnancy and Fertility for Previvors and Survivors
Free on-line seminar
June 19, 7pm EST

Young Survival Coalition Events
Free
Multiple locations/dates

ASCO Breast Cancer Symposium
September 13-15, 2012
San Francisco, CA

Living Beyond Breast Cancer Conference
September 29, 2012
Philadelphia, PA

FORCE Annual Conference
October 18-20, 2012
Orlando, FL

San Antonio Breast Cancer Symposium
December 4-8, 2012
San Antonio, Texas

May 16, 2012 at 10:16 pm Leave a comment



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