BREAST CANCER

<div>The developer of neratinib, Puma Biotechnology, has announced the European Medicines Agency (EMA) has validated the marketing authorization application for neratinib as a potential extended adjuvant therapy for patients with HER2-positive early stage breast cancer following 12 months of trastuzumab (Herceptin).</div>

Pfizer has announced plans to acquire the biopharmaceutical company Medivation, which is the developer of the androgen receptor inhibitor enzalutamide (Xtandi). Under the terms of the agreement, Pfizer will pay $81.50 per share in cash for Medivation, totaling approximately $14 billion. Both companies agreed to the transaction, which is expected to complete later this year.

Approximately 46% of patients with breast cancer at high risk for recurrence but low genomic risk with the 70-gene breast cancer recurrence assay (MammaPrint) might not require adjuvant chemotherapy, according to prospective 5-year results of the MINDACT trial published in&nbsp;<em>The New England Journal of Medicine</em>.¹

Linda Bosserman, MD, medical oncologist, City of Hope, discusses the effects that payment reform may have on clinical practice in oncology.

Eleftherios P. Mamounas, MD, surgical oncologist, UF Health Cancer Center - Orlando Health, compares mastectomy with breast conservation in the surgical management of breast cancer.

The CDK4/6 inhibitor ribociclib (LEE011) has received a breakthrough therapy designation from the FDA for its potential as a frontline therapy when given in combination with letrozole for patients with hormone-receptor (HR)-positive, HER2-negative advanced breast cancer.<br /> &nbsp;

Treatment with anthracyclines was proven to be beneficial for patients with high-risk, HER2-negative, early-stage breast cancer.

Frankie Ann Holmes, MD, medical oncologist, Texas Oncology, discusses the implications of the results of the MA17R trial, which is a randomized phase III clinical trial that examined the benefits of extending aromatase inhibitors with letrozole as a treatment for postmenopausal patients with early breast cancer.

Julia White, MD, professor of Radiation Oncology, Ohio State University, discusses some of the alternative procedures that patients with breast cancer may be able to opt for instead of whole-breast irradiation.

There is a lack of targeted agents for triple-negative breast cancer, which makes it one of the most challenging subtypes of breast cancer to treat; however, that may soon be changing.

Dual anti-HER2-directed therapies have emerged as the most beneficial neoadjuvant treatment option for patients with HER2-positive breast cancer, according to Frankie Ann Holmes, MD.

More options are now available for combining and sequencing therapy for patients with estrogen (ER)&ndash;positive metastatic breast cancer (mBC), including the deployment of CDK4/6 inhibitors, as clinicians endeavor to individualize the sequencing of therapies to improve patient outcomes, according to Maura N. Dickler, MD.

Clifford A. Hudis, MD, CEO of the American Society of Clinical Oncology, discusses the significance of the relationship between breast cancer and obesity.

When it comes to breast cancer treatments, sometimes less is more, according to Hope S. Rugo, MD.

A better understanding of how patients with triple-negative breast cancer respond to neoadjuvant therapy regimens is helping to further individualize therapy for patients while also informing treatment decisions in the adjuvant setting.

The addition of chemotherapy to standard hormonal therapy does not improve survival rates for patients with early breast cancer who are at low-risk for recurrence using the 21-gene recurrence score.

Angela M. DeMichele, MD, professor of Medicine and Epidemiology, University of Pennsylvania, discusses the biology of triple negative breast cancer and the significant role of DNA repair.

Phase III results of the KRISTINE trial demonstrated that patients with HER2-positive early breast cancer had a significantly higher pathological complete response (pCR) rate when they received the neoadjuvant regimen of docetaxel, carboplatin, and trastuzumab plus pertuzumab (TCH+P) versus trastuzumab emtansine (T-DM1) plus pertuzumab (T-DM1+P). &nbsp;

As I write this, the 2016 ASCO conference has just concluded in Chicago. And, as is typical with this event, the amount and level of groundbreaking research and information presented at this year&#39;s conference is nothing less than staggering in its scope, innovation, and promise.

Breast cancer has traditionally not been viewed as immunogenic. There is now a growing body of evidence that immune infiltration has a prognostic role in al breast cancer subtypes, and predicts improved clinical outcome in triple-negative and human epidermal growth factor receptor 2-positive tumors.

For patients with early-stage invasive breast cancer and known estrogen receptor, progesterone receptor, and HER2 status, ASCO&#39;s February 2016 release of their evidence-based recommendations helped define appropriate use of biomarker assay results in guiding adjuvant treatment decisions.

A number of small changes that were specific to neoadjuvant and adjuvant therapies were made to the NCCN breast cancer guidelines, additionally, the recommended treatments for patients with ER-positive disease were also modified.

Allison W. Kurian, MD, MSc, associate professor of Medicine and of Health Research and Policy, Stanford University School of Medicine, discusses two ongoing trials utilizing multi-gene panels to uncover previously undetected risks in patients with breast and ovarian cancer.

Preliminary data shows an anthracycline/taxane-based chemotherapy regimen (TaxAC) could be superior to docetaxal plus cyclophosphamide in patients with breast cancer.

Multigene panel testing may uncover new risks in breast cancer and ovarian cancer.

The combination of T-DM1 and pertuzumab was superior to the combination of paclitaxel and trastuzumab as neoadjuvant treatment for women with HER2-positive breast cancer.

TNFSF11, also known as RANKL, shows potential as a genetic pathway in the prevention of breast cancer for women carrying BRCA1 mutations. Early study findings, published in Nature Medicine, show that a drug currently used in the treatment of osteoporosis, denosumab (Xgeva)-an inhibitor of RANKL-could also be used for the prevention and delay of tumor growth for BRCA1-mutation carriers.

Single-agent abemaciclib as well as taselisib in combination with fulvestrant (Faslodex) could both play a substantial role in breast cancer in the near future, says Maura Dickler, MD.

Joanne Blum, MD, PhD, FACP, physician, Texas Oncology, discusses the combination of fulvestrant and palbociclib (Ibrance) in patients with breast cancer, as well as the synergy fulvestrant has with other CDK4/6 inhibitors.

A new nationwide research project is encouraging patients to share tumor samples and clinical information with researchers in the hope that it will lead to discoveries for new and improved treatment options and, ultimately, a cure, for metastatic breast cancer.