Sanofi-aventis recently announced disappointing results from a Phase 3 clinical trial for patients with metastatic triple negative breast cancer using the investigational drug iniparib, which belongs to a class of drugs called PARP inhibitors. The drug was used in a randomized trial with patients receiving gemcitabine and carboplatin with or without iniparib. No improvement in overall survival or progression-free survival was found in patients taking iniparib as a first-line therapy (the initial, or first, therapy used in a person’s cancer treatment). Improvement was seen in patients receiving iniparib as a second- or third-line therapy.
Many patients were very hopeful after the positive Phase 2 results, so the Phase 3 results surprised some. It is important to remember the difference in the purpose and scope of the trials. Phase 2 trials involve fewer patients and aim to identify the appropriate dosage to ensure a drug is effective and safe. Phase 3 trials are much larger and are intended to confirm the effectiveness of a drug, as well as provide information for physician labeling.
Sanofi-aventis has indicated patients who are currently enrolled in Phase 2 or Phase 3 trials for metastatic breast cancer should not expect disruption of access to this drug, regardless of whether these patients are receiving it as a first-, second- or third-line treatment.
Patients who are currently enrolled in the Expanded Access Protocol (EAP) can continue to get iniparib if they are second- or third-line patients. A new consent form will be required to continue. However, the recommendation from sanofi-aventis, based on the analysis of the Phase 3 data, is that first-line patients discontinue treatment with iniparib. If patients and their physicians think iniparib should be continued based upon the individual’s potential risk and benefit, a new consent form will be required. The enrollment process for patients who are waiting to be enrolled in the EAP program has not changed for second-, third- and fourth-line patients. No new first-line patients will be accepted into the EAP.
Sanofi-aventis has no current plans to discontinue the EAP, but will be meeting with the U.S. Food and Drug Administration (FDA) to discuss the structure and length of the program. They will also continue to evaluate the Phase 3 results to gain a better understanding and to identify the patients who may potentially benefit from iniparib.
Sanofi-aventis is communicating with physicians who have enrolled patients on the trial, is seeking guidance from the FDA about sharing data with patient groups and has submitted an abstract for the American Society of Clinical Oncology (ASCO) meeting in June 2011 to report these findings.
Sanofi-aventis plans to continue its ongoing clinical trials with iniparib for breast, lung and ovarian cancers.
We’ve seen the headlines, we know it’s a groaner, but we just can’t help ourselves. Here goes: “To D or Not to D. Vitamin D, That Is.” (We’re sorry). Folks may be having fun with the headlines, but the subject matter is serious and more than a little confusing. Why the sudden interest in Vitamin D? Do we get enough from the sun or do we need to supplement? How many IU’s is too many IU’s? And does Vitamin D REALLY help protect against breast cancer? In a Komen Perspectives article, we weigh in here.
Acknowledging the FDA conducted a thorough investigation and made a hard decision to propose withdrawing marketing approval for Avastin for metastatic breast cancer, we still want another public hearing to be held. We sent a letter yesterday to the FDA encouraging the agency to hold a hearing to talk about the appeal made by Avastin’s maker, Genentech/Roche.
The FDA cited studies indicating Avastin did not affect overall survival of metastatic breast cancer patients and had significant side effects for many.
However, we also know that for some number of women, Avastin works and works well. We have heard from women who are gaining not just months, but years, with a high quality of life, from this treatment. We are concerned about the potential impact on women who are currently benefiting from Avastin if the FDA removes its approval for its use as a treatment for metastatic breast cancer. We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it, and that their insurers will continue to pay for it.
We also want Genentech/Roche to keep making the drug available to women through its patient support programs, consider an expanded access program and continue research on a biomarker for Avastin to determine which women will benefit from the drug.The full text of the letter is available here
Did you know that breast cancer isn’t just one disease, but rather a disease made up of several subtypes, one of which is triple negative breast cancer?
Triple negative breast cancers are estrogen receptor-negative (ER-), progesterone receptor-negative (PR-) and HER2/neu-negative (HER2-) and about 15 to 20 percent of breast cancers are categorized as such. It’s important to note these tumors tend to occur more often in younger women and African American women. And, many BRCA1 and BRCA2 breast cancers also happen to be triple negative.
These triple negative tumors are often aggressive and have a poorer prognosis compared to the estrogen receptor-positive cancers. Treatment plans usually include some combination of surgery, radiation therapy and chemotherapy.
Although the reasons why younger African American women get triple negative breast cancer are not clear right now, one study suggests lifestyle factors might play a role. And higher rates of triple negative tumors may explain, to some degree, the poor prognosis of breast cancers diagnosed in younger African American women.
To learn more about triple negative breast cancer in African American women, we invite you to register for our upcoming webinar on Monday, Feb. 14 – Triple Negative Breast Cancer in the African American Woman – from 3-4 p.m. CST / 4-5 p.m. EST. Our two speakers for the hour will be Dr. Olufunmilayo Olopade from the University of Chicago Medical Center and survivor and Komen advocate, Tina Lewis. Check out the Facebook event here.Register for the webinar now!
Learn more about Triple Negative Breast Cancer here.
A long-standing surgical routine affecting tens of thousands of women every year may be changing because of a new study and others like it. The newest study, published this week in the Journal of the American Medical Association, has the potential to provide new options for women facing treatment for early stage breast cancers. It found that routine removal of the lymph nodes in someone’s armpit (known as an axillary lymph node dissection, or ALND) doesn’t improve survival or recurrence rates, and is not necessary for some women.
This means that a significant percentage of newly diagnosed breast cancer patients could avoid this painful surgery, which carries serious side effects — the most common of which is lymphedema, an incurable swelling in the arm that can range from mild to disabling. Women in the study who had their nodes removed also were much more susceptible (70% vs. 25%) to complications such as infections, strange sensations and abnormal fluid buildup in the armpit, the study found.
This study and similar recent research are a continuation of a trend toward less invasive surgery for women with breast cancer, and will provide new treatment options for many women. We encourage women to have a frank discussion with their surgeons about whether this approach is suitable for them. We expect that this option will be available first at major breast centers and with surgeons who specialize in breast cancer surgery.
In a TIME article, our president, Liz Thompson joins the study’s authors in discussing the implications on those affected by breast cancer.
“Patients may or may not be ready because we have been taught that with surgery, radiation and chemotherapy, more is better.”
-Liz Thompson, president of Susan G. Komen for the Cure®
We have invested $2.5 million researching the causes and potential treatments for lymphedema and has also funded studies into the use of sentinel lymph nodes as an alternative to axillary node dissection.
Learn more about lymph node status, SNB and ALND here.