
BREAST CANCER
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Ribociclib has been recommended for approval by the Committee for Medicinal Products for Human Use, a part of the European Medicines Agency, for use in combination with an aromatase inhibitor as a first-line treatment for postmenopausal women with HR-positive /HER2-negative locally advanced or metastatic breast cancer.<br />
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A retrospective, multicenter study of 1207 women treated for non-metastatic breast cancer who then became pregnant showed that these survivors faced no greater risk of recurrence or death than their counterparts who underwent treatment but did not become pregnant.

Adding the PD-1 inhibitor pembrolizumab (Keytruda) to standard neoadjuvant chemotherapy tripled the pathologic complete response (pCR) rate in multiple subtypes of HER2-negative breast cancer, according to results from the ongoing phase II I-SPY-2 clinical research program presented during the 2017 ASCO Annual Meeting.

Peter Kaufman, MD, associate professor of Medicine, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, discusses the significance of the MONARCH 2 trial, which explored abemaciclib in combination with fulvestrant in patients with hormone receptor-positive, HER2-negative advanced breast cancer who progressed on endocrine therapy during the 2017 ASCO Annual Meeting.<br />

Sunil Verma, MD, department head, Clinical Department of Oncology, Calgary Zone, medical director, Tom Baker Cancer Centre, discusses updated results of the phase III MONALEESA-2 trial of first-line ribociclib plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer during the 2017 ASCO Annual Meeting.

Debu Tripathy, MD, chair of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, discusses the phase II ABRAZO study of talazoparib following platinum or multiple cytotoxic regimens in advanced breast cancer patients with germline <em>BRCA</em> 1/2 mutations during the 2017 ASCO Annual Meeting.

Sara M. Tolaney, MD, MPH, associate director, clinical research, breast oncology, Susan F. Smith Center for Women’s Cancers, Dana-Farber Cancer Institute, discusses interim results of a trial exploring abemaciclib for the treatment of brain metastases secondary to hormone receptor-positive HER2-negative breast cancer.

Denise Yardley, MD, senior investigator, Sarah Cannon Research Institute, discusses the APHINITY trial, which compared chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with HER2-positive early breast cancer.

The risk of disease progression or death was reduced by 45% with the addition of abemaciclib to fulvestrant compared with that of fulvestrant alone in patients with previously treated HR-positive/HER2-negative breast cancer, according to findings presented during the 2017 ASCO Annual Meeting.

Updated results from the phase III MONALEESA-2 trial presented during the 2017 ASCO Annual Meeting confirmed the benefit of frontline ribociclib (Kisqali) in combination with letrozole in patients with postmenopausal hormone receptor (HR)-positive, HER2-negative advanced breast cancer. The combination showed a progression-free survival (PFS) benefit of 9.3 months compared with letrozole plus placebo.

It’s been a busy month at the FDA. Here’s a look back at all the news in the oncology field to come out of the FDA during the month of May.

Joyce A. O’Shaughnessy, MD, chair of Breast Cancer Research and the Celebrating Women Chair in Breast Cancer at Baylor-Sammons Cancer Center, discusses the promise seen with abemaciclib for the treatment of breast cancer.

Hope S. Rugo, MD, discusses the differentiating factors of abemaciclib among the CDK 4/6 inhibitors for breast cancer treatment.

Anees B. Chagpar, MD, associate professor of Surgery (Oncology), director of The Breast Center at Smilow Cancer Hospital at Yale-New Haven, Yale Cancer Center, discusses ongoing clinical trials in the field of triple-negative breast cancer (TNBC).

Neratinib has been recommended for approval by the FDA’s Oncologic Drugs Advisory Committee in a 12-4 vote for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following postoperative trastuzumab.

An overview of updated guidelines for the management of invasive breast cancer, issued by the National Comprehensive Cancer Network.

More Stage I cancers were diagnosed after the passage of the Affordable Care Act within 5 screenable disease types (colorectal cancer, female breast cancer, cervical cancer, lung cancer, and prostate cancer) than were diagnosed before ACA implementation.

Ruth O’Regan, MD, discusses results of BELLE-3, a phase III study of buparlisib (BKM120) plus fulvestrant (Faslodex) in postmenopausal women with hormone receptor (HR)-positive, HER2-negative breast cancer.

Denise Yardley, MD, senior investigator at the Sarah Cannon Research Institute, discusses the role of nab-paclitaxel (Abraxane) in the treatment of triple-negative breast cancer (TNBC).

The FDA has given its approval to co-packaging of the oral medications ribociclib (Kisqali) and letrozole (Femara) for the treatment of postmenopausal women with HR-positive, HER2-negative advanced breast cancer.

Wolfgang Janni, MD, PhD, discusses toxicity management with neratinib and other agents for HER2-positive breast cancer, as well as emerging treatments and impactful trials in the field.

Debu Tripathy, MD, discusses current and emerging treatment strategies in the neoadjuvant setting for patients with HER2-postive breast cancer.

NYU Langone’s Perlmutter Cancer Center has announced that Ophira Ginsburg, MD, will be director of its new High-Risk Program, which will identify, study, and care for patients with hereditary syndromes that increase their risk for developing cancer.

Elizabeth A. Mittendorf, MD, PhD, associate professor, department of surgical oncology, University of Texas MD Anderson Cancer Center, discusses the promise immunotherapy has shown thus far in breast cancer, particularly triple-negative breast cancer (TNBC).

An overview of FDA news that happened in April.

The treatment paradigm for HER2-positive breast cancer continues to focus on minimizing the role of chemotherapy and determining the optimal combination of HER2-targeted agents for specific patient subsets.
















































