An exciting first happened today! We launched the inaugural “Pink Passions Auction” to honor the promise our founder and CEO, Ambassador Nancy G. Brinker, made to her dying sister, Susan G. Komen, that she would do everything she could to end breast cancer forever. The auction – powered by charitybuzz – is comprised of designer fashions, accessories and home décor items, as well as exclusive beauty treatments, experiences and extravagant trips. Top fashion and accessories brands across the world have come together to donate exclusive pink items to raise funds. Participating brands include: Oscar de la Renta, Hermes, Manolo Blahnik, Valentino, Michael Kors, Badgley Mischka, Tiffany & Co, Bulgari, Kara Ross, Judith Ripka, St. John, Tory Burch, Guiseppi Zanotti, Valentino, Versace and Jimmy Choo.
The support of the fashion community and the unique offerings of the Pink Passions Auction will help us raise the critical dollars we need to advance the science and fund community-level programs that provide answers and assistance to those touched by breast cancer.
Bidding is open through March 23, 2011 at charitybuzz.com/perfectpink.
For women with a choice in early breast cancer treatment, lumpectomy plus radiation therapy (lumpectomy + RT) is considered as effective as mastectomy. When you’re making an informed decision on whether to have lumpectomy + RT or mastectomy, it’s important to explore the issues related to each treatment option.
The newest Komen Perspectives article discusses the differences between lumpectomy and mastectomy, when lumpectomy + RT is an option, as well as the risks and benefits of the two. We hope you’ll take a minute to read more.
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