Archive for July, 2013

From the Director

Elly Cohen, Ph.D., Director

Elly Cohen, Ph.D., Director

At BCT, one of our primary goals is to respond to the needs and interests of our users who turn to our site for information about breast cancer trials. So, when we noticed strong interest in our Vaccine and Immunotherapy QuickView, we decided to delve into the topic further. And that’s what this issue—and the next issue of our newsletter (on vaccines for metastatic breast cancer)—will do. We look forward to reading your comments on our blog about these articles.

I’d also like to ask you to keep your eye out for a short, anonymous survey that will arrive from BCT in your inbox next week. The survey is designed to help us learn more about how BCT helped you, what problems you had using the site (if any), and how you think we can make the site even better. By taking the time to respond, you will help us prioritize our next round of site improvements as well as illustrate to our funders—who make this service possible—our important role in the breast cancer community.

Please forward our newsletter to anyone you know who has breast cancer or works with women who do. Don’t forget to “like” us on Facebook, too. Far too many people still remain unaware of the many clinical trials that are available or understand how these trials work to improve breast cancer care. By working together, we can change that.

July 18, 2013 at 5:31 pm Leave a comment

Vaccines: A New Frontier in Cancer Research

vaccine cartoonThe takeaway from this year’s American Society of Clinical Oncology annual meeting, held in Chicago from May 31 to June 3, was that cancer vaccines and other types of immunotherapy drugs are one of the more promising new directions in cancer treatment.

Immunotherapies are cancer treatments that are designed to get the immune system to treat cancer cells as they would bacteria or a virus—a foreign invader that should be attacked. (Because cancer cells start off as normal cells, the immune system basically ignores them.) The American Cancer Society provides a good overview of immunotherapies and how they work here.

Cancer treatment vaccines are one type of immunotherapy. You can see a list of the breast cancer vaccine trials that are now underway in our Vaccines and Immunotherapy QuickView.

To learn more about breast cancer vaccine trials, BreastCancerTrials.org spoke with Elizabeth Mittendorf, a surgical oncologist at MD Anderson Cancer Center in Houston about her phase III international NeuVax vaccine trial(This is the only breast cancer vaccine currently being studied in a phase III trial.) We also spoke to Diane Altenburg, a breast cancer survivor who took part in the phase II trial of NeuVax.  You can read these interviews here:  Dr. Elizabeth Mittendorf     Diane Altenburg

July 18, 2013 at 5:29 pm 4 comments

Q & A with Elizabeth Mittendorf: A Vaccine to Prevent Recurrence

Dr. Elizabeth Mittendorf

Dr. Elizabeth Mittendorf

Dr. Elizabeth Mittendorf is leading an international phase III clinical trial that is exploring whether the NeuVax vaccine can reduce the risk of recurrence in women with stage II-IIIa, lymph-node positive, HER2-negative breast cancer. Patients in the trial receive an injection (into the skin) once a month for six months (6 total) and then booster shots every six months for 30 months (5 total).

Q:  How was this vaccine developed?
A: Investigators at MD Anderson found that breast and ovarian cancer cells had an epitope—a part of a molecule the immune system recognizes as foreign—that T-cells were attracted to. Because T-cells are the front line of the immune system’s defense mechanism, this suggested we might be able to develop a vaccine that would augment this process and kill cancer cells.

It took quite awhile to get Neuvax, which is a peptide vaccine, into clinical trials. (A peptide is a sequence of amino acids. You can learn more about peptides and their role in vaccines here. We wanted to use NeuVax in the adjuvant setting, giving it to women who have just completed treatment with the goal of preventing recurrence. Previous peptide vaccine trials tested vaccines in patients who already had metastatic disease (most had metastatic melanoma). Those trials weren’t successful, and we were hoping that using a peptide vaccine in the adjuvant setting would be more effective.

Q: Why would a peptide vaccine not work in the metastatic setting?
A: There are two reasons a peptide vaccine is largely not successful in the metastatic setting. One, a metastatic site is made up of millions of tumor cells, and trying to get the immune system to stimulate enough T-cells to go after millions of tumor cells is difficult. The other reason is that the vaccine does not affect the microenvironment—non-cancerous cells that surround the tumor cells. Some of these cells contain proteins called cytokines that are known to be unfriendly to T-cells.

That said, we are starting to see immunotherapy drugs coming down the pike in metastatic melanoma like ipilimumab (Yervoy). It works by blocking a molecule on T-cells that typically keeps the T-cells from going after cancer cells. This is increasing enthusiasm for immunotherapy. A single peptide vaccine, such as Neuvax, may not be effective for metastatic disease, but it’s possible that a peptide vaccine might be given in combination with other types of immunotherapy to treat metastatic breast cancer.

Q: When did you start the phase I trial?
A: We started the phase I trial back in 2001. The safety data from that study allowed us to role into a phase II study that enrolled approximately 190 patients. The last patients were enrolled in that study in 2007. Our most recent published study on this trial is our 24-month landmark analysis, which showed that the vaccine was clinically effective, but that some patients had a better immune response and what appears to be a trend toward a reduced risk of recurrence than others. These results led to the phase III trial we now have underway.

Q:  Has it been difficult to get women to enroll in this trial?
A: It’s not that difficult to find women. The problem is that there are many other clinical trials that are looking at ways to reduce the risk of recurrence that are enrolling similar patients. Also, we have a very stringent timeline for enrollment. [Women must enroll within 30 days of completing chemotherapy or radiation.]

Q: Could this vaccine also be used to treat DCIS or for breast cancer prevention?
A: If we go to the FDA to seek approval of the vaccine, it would be to treat the same group of women who are enrolled in the trial. So the correct answer would be no. But if investigators can identify through this trial and other trials a biomarker (a biogical marker) that predicts which patients will respond to the vaccine, then it would be possible to do trials investigating the vaccine in patients with DCIS who have that marker. A prevention trial would require a large number of women, take at least 20 years, and be cost prohibitive. That’s the opposite of what we are trying to do now, which is to design sleeker, more efficient trials.

Q: What should women with breast cancer know about the vaccine?
A: I’d like to emphasize that the vaccine is for women who are HER2-negative. I also want women to know that early studies suggest it may reduce the risk of recurrence by 50 percent, and that it’s non-toxic. Women experience some redness at the injection site and some experience some flu-like bone pain, but that goes away. If it’s successful, it will be an important development for HER2-negative patients.

July 18, 2013 at 5:29 pm 1 comment

Diane Altenburg: Entering a Vaccine Trial

Diane Altenberg

Diane Altenberg

In 2005, breast cancer survivor Diane Altenburg enrolled in the phase II trial of NeuVax.

Q: When were you diagnosed with breast cancer and how were you treated?
A: My first diagnosis of breast cancer was in 2000, when I was 53. The tumor was in my right breast. I had a lumpectomy followed by radiation and then went on tamoxifen. I was in my fourth year of tamoxifen when I was diagnosed with cancer in my left breast. This time the cancer had already spread to my lymph nodes. I had a lumpectomy followed by radiation and chemotherapy and then started Arimidex.

Q: How did you hear about the NeuVax clinical trial?
A: I was treated at the Walter Reed National Military Center and my oncologist suggested that I participate. They wanted you to be as cancer-free as possible when you entered the trial, so you had to enroll within a month of finishing chemotherapy or radiation. It was the first time I had been in a clinical trial.

Q: What motivated you to take part?
A: After my first breast cancer diagnosis I became a patient advocate and in that volunteer role I worked with Walter Reed to develop its multidisciplinary breast care center. This was in 2001, when hospitals were just starting to develop centers where women could be seen by all of their doctors instead of having to go to a number of different places. It was a new way of looking at breast cancer care, and getting involved was my way of giving back. When I was diagnosed the second time, my doctor told me that I’d be a good candidate for the trial and taking part was my way of helping other women so that they wouldn’t have to deal with this.

Q: Was was it like being in the trial?
A: There were between 60 and 80 women in the trial at Walter Reed. It was the easiest thing. The hardest part was driving 30 miles through traffic to get to Walter Reed, which was then in Washington, DC, from my home in Virginia. I had to go there to get the vaccine and then go back again a few days later, when they took a blood sample and measured the size of the welt at the injection site. The welt looked like a mosquito bite, except a bit bigger. There was no pain at all. I got a little tired in the afternoon, but there was nothing that I had to give up.

Q: Would you encourage women to take part in the phase III trial?
A: Absolutely. I would do it all again.

July 18, 2013 at 5:28 pm Leave a comment

Calendar/Events: Summer 2013

American Society of Clinical Oncology Breast Cancer Symposium
September 7- 9, 2013
San Francisco, CA
For patient scholarships: contact patientadvocate@asco.org.

Metastatic Breast Cancer Network: 7th National Conference
“New Directions in Metastatic Breast Cancer”
September 20-22, 2013
Houston, TX

San Antonio Breast Cancer Symposium
December 10-14, 2013
San Antonio, TX

Young Survival Coalition Annual Conference for Young Women Affected by Breast Cancer 
February 21-23, 2014
Orlando, FL

Free Teleconferences and Webinars

Newly Diagnosed: Using Complementary Therapies to Manage Side Effects
Living Beyond Breast Cancer
July 25, 2013
Noon – 1:00 pm ET

Updates in the Treatment of Estrogen Receptor Positive and Progesterone Receptor Positive Breast Cancer and Triple Negative Breast Cancer
CancerCare.org
July 31, 2013
1:30pm – 2:30pm ET

July 18, 2013 at 5:26 pm Leave a comment



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