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FDA Proposes Modernization of Mammography Services

​The FDA has proposed regulatory amendments to improve the quality of breast cancer screening by expanding the information provided to patients and physicians, modernizing standards for mammograms, and enabling better enforcement of safety and quality regulations. "Breast cancer is one of the most worrisome health concerns facing women. The FDA plays a unique and meaningful role in the delivery of quality mammography to help patients get accurate screening to identify breast health problems...

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Fulvestrant/Anastrozole in Metastatic Breast Cancer: Long-Term Efficacy

A phase 3 clinical trial (NCT00075764) reports that for postmenopausal patients with hormone receptor (HR)-positive metastatic breast cancer, adding fulvestrant (Faslodex®, AstraZeneca) to anastrozole (Arimidex®, AstraZeneca) as first-line therapy increases long-term survival in comparison with anastrozole alone. Approximately two thirds of breast cancers are HR-positive, meaning that the cancer cells have receptors that attach to the hormones estrogen and/or progesterone. For HR-positive cancer...

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Breast Cancer: Liquid Biopsies Better Than Tumor Biopsies

Patients with hormone receptor (HR)-positive metastatic breast cancer are typically treated with endocrine therapy. However, patients with mutations in the genes PIK3CA and ESR1 usually develop resistance to endocrine therapy. To discover ways to effectively identify PIK3CA and ESR1 mutations in patients with HR-positive metastatic breast cancer and predict treatment outcomes, researchers at Stanford University evaluated the efficacy of using liquid biopsies compared with solid tumor biopsies to...

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An Alternative to Biopsy: Improved CTC Collection Method

​Researchers at the University of Michigan have developed a prototype of a wearable device that can continuously collect circulating tumor cells (CTCs) directly from a patient's bloodstream. The investigators hope that this device, which has thus far proven successful in canine models, could ultimately be used as an alternative to biopsies. Circulating tumor cells, which circulate through lymphatic channels and blood after they are shed from the primary tumor, are the basis for cancer metastases...

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Eribulin Is Effective in Metastatic Breast Cancer

For many patients with metastatic breast cancer, a resistance to hormone therapy develops, and cumulative toxicity, comorbidities, performance status, and prior adjuvant therapy influence the next step for treatment. Due to all of these factors, finding an effective, well-tolerated treatment can be difficult. However, results from a phase 3 clinical trial, published in the European Journal of Cancer, reveal that scientists are a step closer to this goal: eribulin (Halaven®, Eisai Inc.) monothera...

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How Does Green Tea Lower Breast Cancer Risk?

Catechins—phenolic compounds with antioxidant properties—from green tea extract (GTE) lower the risk of breast cancer, but how do these compounds do so? In an effort to find out, a team of researchers investigated one potential theory: that GTE may modulate hormones. The clinical trial compared levels of sex hormones and insulin-like growth factors (IGF) in 1,012 healthy postmenopausal women randomly assigned to take a GTE capsule (n=538) or a placebo pill (n=474). Women in the GTE group took fo...

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The Impact of the FDA’s Revised Mammography Guidelines: Theresa W. Gillespie, PhD, MA, RN

For the first time in over 20 years, the FDA has proposed amendments to the Mammography Quality Standards Act (MQSA) in an effort to expand the information provided to patients and physicians, modernize standards for mammograms, and enable better enforcement of safety and quality regulations. In this interview with i3 Health, Theresa W. Gillespie, PhD, MA, RN, Professor at Emory University School of Medicine and at Emory's Winship Cancer Institute, discusses the significance of these changes and...

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Metastatic Breast Cancer: Palbociclib Now Approved for Men

​The FDA has now expanded the indication for palbociclib (Ibrance®, Pfizer Inc.) in combination with an aromatase inhibitor or fulvestrant (Faslodex®, AstraZeneca) to include men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Because breast cancer in men is rare, comprising less than 1% of all breast cancer cases, men with breast cancer are more likely to be diagnosed at an older age and with a more advanced sta...

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Tucidinostat (Chidamide)/Exemestane Effective in Breast Cancer

​A phase 3 clinical trial reports that tucidinostat (Epidaza®, Chipscreen Biosciences Ltd) in combination with exemestane (Aromasin®, Pfizer Inc.) improves progression-free survival compared with exemestane alone in postmenopausal patients with advanced, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer experiencing disease progression following prior endocrine therapy. Also known as chidamide, tucidinostat is an orally bioavailable subtype-se...

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Ado-Trastuzumab Emtansine Approved in HER2-Positive Early Breast Cancer

The FDA has now approved ado-trastuzumab emtansine (Kadcyla®, Genentech Inc) for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer with residual invasive disease following neoadjuvant taxane and trastuzumab-based treatment. The clinical trial KATHERINE (NCT01772472), results of which were published in The New England Journal of Medicine, contained a population of 1,486 patients with HER2-positive early breast cancer. In order to qualify for the study, pat...

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Lifetime Brain Metastasis Risk in Older Patients With Cancer

Older adults with lung, breast, and skin cancers have an increased risk of developing brain metastasis during their lifetime. But how big is this risk? In an effort to find out, researchers used data from the Surveillance, Epidemiology, and End Results (SEER) Program on patients with lung cancer, breast cancer, or melanoma diagnosed with a brain metastasis, either one identified during primary cancer staging workup, called a synchronous brain metastasis (SBM), or one detected later in life, call...

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Characterization of HER2-Positive Non-Invasive Breast Cancer

Ductal carcinoma in situ (DCIS), or non-invasive breast cancer, can mutate into metastatic breast cancer. Ductal carcinoma in situ is reported as being human epidermal growth factor receptor 2 (HER2) positive in 50% of cases; in contrast, invasive breast cancer (IBC) cases have a lower prevalence of HER2 positivity. In many cases, HER2-positive breast cancers have a tendency to be more aggressive than other types of breast cancer and can sometimes be difficult to treat, as these malignancies are...

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Are Cell Lines the Best Model to Analyze Breast Cancer Biology?

Cell lines—a cell culture developed in a lab from a single cell causing all cells to have the same genetic makeup—are a popular tool to analyze breast cancer biology and test drug candidates. However, sometimes a drug that shows promising preclinical performance fails when used in the clinic. To further the understanding of cell line biology compared with tumors, researchers have begun analyzing large volumes of data, called big data, consisting of genomic data from cell lines and tumors. The an...

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In Premenopausal Breast Cancer, Soy Reduces Fracture Risk

According to a new study, consuming soy-containing foods and maintaining a healthy weight can help pre- and perimenopausal survivors of breast cancer to reduce their risk of fractures. Survivors of breast cancer are at a significantly increased risk of osteoporosis-related fractures, largely due to a reduction in bone mineral density caused by estrogen deprivation therapies. In addition, chemotherapy or ablation of ovarian function can induce premature menopause among younger patients with breas...

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Alpelisib Now FDA Approved for Advanced Breast Cancer

The FDA has now approved alpelisib (Piqray®, Novartis) as the first PIK3CA inhibitor for postmenopausal women and men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated advanced or metastatic breast cancer. Alpelisib is to be used in combination with fulvestrant following progression on or after an endocrine-based regimen. PIK3CA mutations are usually a predictor of poor prognosis, and these mutations occur in about 40% of patients with ...

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Ribociclib Plus Endocrine Therapy Increases Overall Survival in Premenopausal Breast Cancer

Premenopausal women who are diagnosed with breast cancer usually have a worse prognosis than those diagnosed who are postmenopausal; however, they receive similar therapy recommendations despite these prognosis differences. In order to develop a more tailored treatment for premenopausal women, researchers conducted a phase 3 trial called MONALEESA-7 (NCT02278120) that investigated ribociclib (Kisqali®, Novartis), a CDK4/6 inhibitor, in combination with endocrine therapy. Results demonstrated tha...

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Successfully Capturing Cancer Cell Clusters

Circulating cancer cell clusters are associated with many treatment-related challenges that arise, including metastases, recurrence, and developed therapeutic resistance. Although these clusters need to be investigated further to increase understanding of the underlying mechanisms behind the challenges they present, little research has been conducted on them because they are difficult to capture. Investigators seeking to solve this problem have now found a successful method for targeting cancer ...

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Breast Cancer: Genomic and Clinical Risk Predict Outcomes

Women with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer can be provided prognostic information based on clinicopathological features such as tumor size, histologic grade, and the presence of axillary lymph node metastases, but these factors are not always predictive of benefit from adjuvant chemotherapy. Instead, the 21-gene recurrence score, a prognostic predictive tool independent of clinicopathological features, can predict rate of di...

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MRI Superior to Mammography for Familial Breast Cancer Risk

​Around 15% of women with breast cancer have a family history of this disease without an identified causative hereditary genetic mutation. For these women, screening guidelines vary worldwide. A study reports that in women with a family history of breast cancer, magnetic resonance imaging (MRI) plus mammography is superior to mammography alone for early cancer detection. The study, done at 12 hospitals in the Netherlands and published in The Lancet Oncology, enrolled 1,355 women aged 30 to 55 wi...

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Trastuzumab Duocarmazine in HER2-Positive Cancers

​A phase 1 clinical trial reports that trastuzumab duocarmazine, a new antibody-drug conjugate that targets human epidermal growth factor receptor 2 (HER2), shows promise in patients with HER2-expressing breast cancer and in HER2-positive advanced and metastatic solid tumors. An antibody-drug conjugate is a type of immunotherapy containing a selective monoclonal antibody, a cytotoxic (cell-killing) agent that causes cell death in the target tumor cell, and a chemical linker that releases the cyt...

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