HER2 Breast Cancer

Chau T. Dang, MD discusses several recent trials investigating novel treatment approaches for patients with HER2-positive breast cancer.

A new drug application (NDA) for neratinib as an extended adjuvant therapy for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab (Herceptin) has been accepted by the FDA

<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>

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.

In patients with HER2-positive early breast cancer, data from a phase III trial has shown a significantly higher pathological complete response (pCR) rate with neoadjuvant docetaxel plus carboplatin plus trastuzumab plus pertuzumab versus trastuzumab emtansine plus pertuzumab.

Neratinib, an experimental TKI being developed for breast cancer, achieved a 36% clinical benefit rate in a phase II trial, according to a poster presented June 5, 2016 at the ASCO Annual Meeting in Chicago.

Following a series of meetings with the FDA, Puma Biotechnology announced that it plans to delay the submission of a new drug application (NDA) until mid-2016 for neratinib.

Sunil Verma, MD, Medical Director, Tom Baker Cancer Centre, Professor and Department Head, Oncology, Cumming School of Medicine, University of Calgary, discusses the future of immunotherapies and anti-HER2 drugs in the treatment paradigm for HER2-positive breast cancer.

Verma says one of the major new understandings of the disease is that the HER2 receptor needs to be suppressed at all times within the treatment paradigm of the malignancy.

An adjuvant combination of trastuzumab (Herceptin) and paclitaxel could change the treatment paradigm for patients with HER2-positive breast cancer, according to Kimberly L. Blackwell, MD.

Approximately 33% of patients with HER2-positive breast cancer have also been found to have a luminal subtype resistant to chemotherapy and trastuzumab. Peter Beitsch, MD, discusses the triplet neoadjuvant regimen of pertuzumab, trastuzumab, and chemotherapy, and its effect on the subtype in the Neoadjuvant Breast Registry Symphony Trial (NBRST) study.

Neratinib continued to show similar rates of disease-free survival for patients with HER2-positive early-stage breast cancer, according to a 3-year exploratory analysis of the ExteNET trial.

Erika P. Hamilton, MD, discusses the current treatment paradigm, and upcoming treatments, for HER2-positive breast cancer.

Therapies in the adjuvant setting like trastuzumab (Herceptin) and neratinib have shown more durable responses in patients with HER2+ breast cancer, as opposed to long-term treatment, said Mohammad Jahanzeb, MD.

Howard A. &quot;Skip&quot; Burris, III, MD, president, Clinical Operations, chief medical officer and executive director of Drug Development, Sarah Cannon, talks about chemotherapy in the era of personalized medicine.

Mohammad Jahanzeb, MD, medical director, Sylvester Comprehensive Cancer Center at Deerfield Beach, talks about the future of treatment for patients with HER2-positive breast cancer with drugs like neratinib and trastuzumab.

Hans-Christian Kolberg, MD, doctor of Medicine, Marien Hospital Bottrop in Bottrop, Germany, discusses neoadjuvant chemotherapy with docetaxel, carboplatin, and weekly trastuzumab for patients with HER2-positive early breast cancer.

Clifford A. Hudis, MD, FACP, Vice President for Government Relations and Chief Advocacy Officer, Chief, Breast Medicine Service at Memorial Sloan Kettering Cancer Center, talks about the vague understanding medical professional currently have of HER-2 breast cancer and its resistance to certain therapies.

Kimberly L. Blackwell, MD, professor of Medicine, assistant professor of Radiation Oncology, Duke Cancer Institute, discusses upcoming trials for the HER2-antibody margetuximab.

Fred C. Kass, MD, oncology/hematology, internal medicine, Cancer Center of Santa Barbara, discusses HER2-positive breast cancer advancements.

While targeting HER2 mutations is mainly associated with breast cancer, there could be therapeutic potential with anti-HER2 agents in non-small cell lung cancer (NSCLC).

Pertuzumab (Perjeta), in combination with trastuzumab (Herceptin) and chemotherapy, was approved by the European Commission (EC) as a neoadjuvant therapy for adult patients who have HER2-positive, locally advanced, inflammatory, or early stage breast cancer and are at high risk of recurrence.

Shannon Puhalla, MD, assistant professor of medicine, Division of Hematology/Oncology, University of Pittsburgh, discusses a phase III study examining the combination of palbociclib and fulvestrant for the treatment of patients with relapsed metastatic hormone receptor-positive, HER2-negative breast cancer.