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Metastatic Breast Cancer Breakthrough 2021

Top Story In Metastatic Breast Cancer: Projecting The Prevalence And Cost Of Metastatic Breast Cancer From 2015 Through 2030

A New Breast Cancer Treatment Could Be A Game Changer

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  • Celcuity Announces Fda Breakthrough Therapy Designation For Gedatolisib For Treatment Of Hr+/her2

    MINNEAPOLIS, MN / ACCESSWIRE / July 18, 2022 / Celcuity Inc. , a clinical-stage biotechnology company focused on development of targeted therapies for hormonally driven cancers, today announced that the U.S. Food and Drug Administration has granted gedatolisib Breakthrough Therapy designation for the treatment of patients with HR+/HER2- metastatic breast cancer whose disease progressed during treatment with a CDK4/6 therapy and a non-steroidal aromatase inhibitor. Gedatolisib is a potential first-in-class pan-PI3K/mTOR inhibitor.

    Breakthrough Therapy Designation is granted by the FDA to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition. The criteria for Breakthrough Therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on one or more clinically significant endpoints over available therapy. The benefits of Breakthrough Therapy Designation include more intensive guidance from the FDA on an efficient development program, access to a scientific liaison to help accelerate review time, and potential eligibility for priority review if relevant criteria are met. Gedatolisib previously received Fast Track designation from the FDA in January 2022.

    About Gedatolisib

    About Celcuity

    Forward-Looking Statements


    An Innovative Treatment To Assess Breast Cancer Treatment Response

    This year over 5,500 British Columbians that will be diagnosed with a womens cancer.

    Dr. Jenny Ko

    Long-time advocates of breast cancer research and care, Abbotsfords Crystal Gala Foundation recently donated $100,000 to advance an innovative study at BC Cancer.

    The Breast Optical Probe Study at BC Cancer Abbotsford uses a specially engineered probe to accurately assess a breast tumours response to treatment in patients with advanced breast cancer, who are undergoing chemotherapy before surgery.

    The hand-held device can differentiate between normal and cancerous tissues using light properties, helping experts more accurately determine if a tumour has shrunk or changed, in response to chemotherapy or if further treatment needs to continue.

    The probe can provide a detailed, faster result than the more common methods in breast cancer detection, which often include mammography, ultrasound and magnetic resonance imaging .

    Its a tool we can use in the clinic in real-time, as opposed to sending someone to radiology or another department, says Dr. Jenny Ko, Medical Oncologist and Director of the Clinical Trials Unit at BC Cancer Abbotsford. And it has the potential to possibly expand to be used with other tissues, beyond breast tumours.

    The probe will be located at BC Cancer Abbotsford for the duration of the study with this next phase in the research made possible by the generous donation from the Crystal Gala Foundation.

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    Msk Collaborates With Biontech To Test Mrna Vaccines Against Pancreatic Cancer

    MSK researchers are investigating the potential of deploying messenger RNA vaccines against pancreatic cancer. A collaboration with BioNTech which developed the Pfizer-BioNTech COVID-19 vaccine has led to a clinical trial testing this new treatment. The trial is led by physician-scientist Vinod Balachandran, who discovered several years ago why some people with pancreatic cancer survive many years after diagnosis. In these patients, the immune system keeps the cancer from returning.

    The new trial uses mRNA vaccines based on this concept. The vaccine is being tested in pancreatic cancer patients in combination with another type of immunotherapy. The phase 1 trial was completed in June 2021.

    This has been a great example of MSKs forward-thinking vision in cancer care to bring the most exciting medicines to cancer patients, Dr. Balachandran says.

    San Antonio Breast Cancer Symposium 2021 Wrap Up

    Metastatic Breast Cancer

    Recap by Emily ORourke, Research & Business Operations Associate at Outcomes4Me

    Last week top breast cancer oncologists and researchers attended the 44th Annual San Antonio Breast Cancer Symposium , the worlds premier conference for presenting novel breast cancer research. The conference features breakthrough clinical trial results, including promising new approaches to treatment and solutions to current gaps in breast cancer care. Weve highlighted a few major takeaways from the conference.

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    Palbociclib Shows Efficacy In Black And Hispanic Patients

    Approximately 10% of the patients in the trials that lead to the approval of palbociclib were black or Hispanic. This underrepresentation led researchers to review palbociclibs efficacy and safety data specifically in black and Hispanic patients. The data showed that outcomes in black and Hispanic populations taking palbociclib plus endocrine therapy were consistent with the overall study. The median overall survival for patients who took palbociclib plus endocrine therapy was 35 months in the study population and was 36 months in the black and Hispanic populations. The safety data was also similar in the black and Hispanic population compared to the overall population. While this data supports the continued use of palbociclib in HR+, HER2- advanced black and Hispanic patients, their minimal representation in the trials that lead to palbocilibs approval highlights the issue of underrepresentation of minorities in clinical trials.

    Krop Captures 2021 Breakthroughs In Metastatic Her2+ Breast Cancer

    Caroline SeymourSupplements And Featured Publications

    Ian E. Krop, MD, PhD, discusses highlights from 2021 in HER2-positive breast cancer and expectations for future research in 2022.

    One theme of 2021 in HER2-positive breast cancer that will carry into 2022 is the progress that has been made for patients with brain metastases, using such agents as tucatinib and fam-trastuzumab deruxtecan-nxki , explained Ian E. Krop, MD, PhD. He added that the next step will include the investigation of these agents in the early-stage setting and a careful look into the populations who can benefit from deescalated therapy.

    We still have to work on patients with brain metastases. The regimen from the HER2CLIMB trial with tucatinib showed the possibility of real significant progress. Now, we need to keep building upon that. The other real area is trying to deescalate therapy. Thats why there are trials like the CompassHER2-pCR study and the Decrescendo trial in Europe, said Krop.

    In an interview with OncLive®, Krop discussed highlights from 2021 in HER2-positive breast cancer and expectations for research in 2022. He is an associate professor of medicine, Harvard Medical School associate chief, Division of Breast Oncology, Susan F. Smith Center for Womens Cancers and medical oncologist and clinical research director, Breast Oncology Center, Dana-Farber Cancer Institute.

    Read Also: What Is The Treatment For Stage 2 Breast Cancer

    Emerging Areas In Metastatic Breast Cancer Treatment

    This is a promising time in metastatic breast cancer research. Many new treatments for metastatic breast cancer are under study and treatment is improving. Most of these new treatments are drug therapies.

    Findings from clinical trials will determine whether or not these new treatments become a part of the standard of care for metastatic breast cancer.

    Some treatments may even go on to be used for early-stage breast cancer care.

    Learn about clinical trials.

    Nitrates From Food Additives May Be Associated With Breast Cancer Risk

    Local mom with stage 4 metastatic breast cancer defying odds and cycling on

    A study with 101,056 adults, 966 of whom were diagnosed with breast cancer, looked at the association between diets high in nitrates and cancer risk. Nitrates occur naturally in drinking water and other foods, but they are also added to certain meat products, like ham, bacon and deli meats, to increase their shelf life. Researchers found that people with a high level of added nitrates in their diet had a 24% higher risk of breast cancer than those who did not consume nitrates from food additives. These results need to be confirmed through larger studies.

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    Other Uses Of Circulating Tumor Dna In Breast Cancer Treatment

    If treatment with the drug alpelisib is being considered, circulating tumor DNA testing can be used to see if the cancer cells have a PIK3CA tumor gene mutation .

    Komen Perspectives

    Our commitment to research

    At Susan G. Komen®, we are committed to saving lives by meeting the most critical needs in our communities and investing in breakthrough research to prevent and cure breast cancer. Our Research Program is an essential driving force for achieving this mission.

    Since our inception in 1982, Komen has provided funding to support research grants that have greatly expanded our knowledge of breast cancer and helped us understand that breast cancer is not just a single disease but many diseases, unique to each individual.

    To date, Komen has provided nearly $1.1 billion to researchers in 47 states, the District of Columbia and 24 countries to support research that has resulted in a better understanding of breast cancer earlier detection personalized, less invasive treatments for what was once a âone-treatment-fits-allâ disease and improvements in both quality of life and survival rates.

    Learn more about our continuing investment in research and the exciting research that we are funding, because nothing would make us happier than ending breast cancer forever.

    Treatment Updates For Metastatic Breast Cancer

    Elina Delgado, PharmD, BCPS, Assistant ProfessorKiernan A Taylor, PharmD Candidate 2022Phyllis Tran, PharmD Candidate 2022William Carey University School of Pharmacy, Tradition CampusDepartment of Pharmacy PracticeBiloxi, Mississippi

    US Pharm. 2021 46:42-46.

    ABSTRACT:About one in eight women will be diagnosed with breast cancer in her lifetime. Of these, 6% will have metastatic disease that carries a 5-year survival rate of about 29%. The year 2020 brought about FDA approval for three new agents targeting varying forms of metastatic breast cancer in the hope that more women will be able to successfully combat this stage of disease. The approval of Trodelvy provides a second-line treatment option for patients with triple-negative metastatic breast cancer. For patients with HER2+ metastatic breast cancer, Tukysa and Margenza are new second- and third-line options available.

    To date, there is no single standard of care for MBC. Treatment goals for MBC consist of prolonging survival, palliating symptoms, and delaying the progression of the disease, since MBC remains incurable. Treatment for MBC includes chemotherapy , surgery, radiation, hormonal therapy, immunotherapy, and gene therapy.6,8 Treatment plans are individualized based on the benefits and risk factors of therapeutic agents, previous treatment, and clinical status.

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    Breakthrough Metastatic Breast Cancer Treatment Hits Snag

    CHICAGO A stunning breakthrough in treating metastatic breast cancer caught the attention of patients around the world. Early findings showed a new compound killed 95 to 100 percent of cancer cells in animals. But the promising new drug may have hit a snag on its road to human trials.

    It was hard to imagine that we had a drug that would take cancers and cause them to just disappear in a matter of days, said biochemistry professor David Shapiro. That was his reaction when imaging came back showing that the drug ErSO successfully targeted and killed metastatic breast cancer tumors in mice.

    All the tumors have been eradicated, they’ve been destroyed and they’re no longer detectable, he told us back in August.

    The compound developed by a team at the University of Illinois Urbana-Champaign worked in just days, without reoccurrence of cancerous tumors or any noticeable side-effects.

    We have been making these kinds of drugs for over a decade and none of them ever did anything remotely like that, said Shapiro.

    It was so promising that pharmaceutical giant Bayer bought the exclusive licensing rights to develop ErSO as a cancer therapy in partnership with Arizona-based Systems Oncology a year before the Illinois study was even published. It was a deal originally worth up to $370 million.

    For metastatic breast cancer patients around the world, it was astounding.

    Hundreds of people like Mullins formed an advocacy group on Facebook to follow the ErSO progress.

    Surgery: Lymph Node Transplants And Time

    #VisualAbstract: Overall Survival with Fulvestrant plus Anastrozole in ...

    Breast cancer often spreads to the lymph nodes, so patients who have breast cancer surgery often also have a lymph node under their arm removed and examined. If cancer is found, more lymph nodes may need to be removed.

    An unfortunate but common long-term side effect of this process is lymphedema, or swelling in the arm. Its caused by fluid buildup in the arm tissue that occurs when the lymphatic system is damaged.

    MedStar Health now has a plastic surgeonLaura Tom, MDwho specializes in an innovative lymphovenous bypass surgery that relieves the swelling. Transferring lymph nodes from a healthy part of the body into the swollen arm helps the fluid drain appropriately.

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    Best Breast Cancer Breakthroughs Of 2021

    It seems unbelievable that were ready to review the best breast cancer breakthroughs of 2021, but here we are! This year has flown by and many exciting discoveries have been made in the field of breast cancer research.

    According to a study conducted using 2020 statistics and published in “CA: A Cancer Journal for Clinicians”, breast cancer surpassed lung cancer as the most common type of cancer diagnosed around the world. There were an estimated 2.3 million new cases of breast cancer in 2020, which represents a whopping 11.7 percent of all cases of cancer diagnosed around the world last year. As a result, breast cancer research is now more important than ever and fortunately, new discoveries are being made with astonishing speed.

    This year has brought us a lot of new information surrounding breast cancer. Researchers have given us very positive news to discuss, from the discovery of a positive association between a plant-based diet and lower breast cancer risk, to the fact that regular exercise could help relieve chemo brain during chemotherapy. Additionally, new treatments are currently being studied and show a lot of potential for the future, and older medications have also been found to have a positive impact on breast cancer treatments.

    We never fail to be amazed by these discoveries at the end of every year and 2021 is no exception. Keep reading to discover some of the best breast cancer breakthroughs of 2021.

    Canada’s Largest Philanthropic Gift To Lung Cancer

    On February 4th, to mark World Cancer Day, the BC Cancer Foundation announced a historic philanthropic investment of $15.3 million from the Leon Judah Blackmore Foundation to advance lung cancer research and care.

    Drs. Wan Lam, Stephen Lam, Calum MacAulay and William Lockwood

    This transformational donation is Canadas largest known philanthropic investment specifically supporting lung cancer and will place BC Cancer at the global forefront of innovation in early detection, treatment and high impact research.

    Lung cancer is the leading cause of cancer-related death in B.C., across Canada and worldwide. Six British Columbians die of lung cancer every day.

    Far too many families in B.C. and around the world have experienced pain and loss at the hands of lung cancer, says Sarah Roth, president & CEO, BC Cancer Foundation. On behalf of all individuals with this devastating illness, I thank the Leon Judah Blackmore Foundation for the hope theyve provided.

    Leading the vision is Dr. Stephen Lam, Leon Judah Blackmore Chair in Lung Cancer Research, BC Cancer, who is at the global helm of lung cancer research and treatment.

    Alan Soon with his family

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    What Is This Breakthrough

    A study published in Cancer Epidemiology, Biomarkers, and Prevention studied the effect that following both healthy and unhealthy plant-based diets could have on the development of breast cancer. The foods that were included in the definition of a plant-based diet included:

    • Fruits

    On the other hand, unhealthful plant-based diets were those that regularly included:

    • Beverages with added sugar
    • Refined grains
    • Potatoes/fries

    The study followed nearly 169,000 women who had to complete a survey detailing their food intake every four years. Once the study was completed, researchers found that women who followed a consistent plant-based diet particularly a healthful plant-based diet had an 11 percent decrease in their breast cancer risk, and a 23 percent lower risk of developing aggressive ER-negative breast cancer, in particular.

    Massachusetts General Cancer Center And Outcomes4metm Joint Study Points To Need For Improved Patient Education And Medical Record Access

    Breakthroughs in metastatic breast cancer treatment

    Outcomes4MeTM presented research from a recent study conducted at Massachusetts General Cancer Center comparing patient reported disease characteristics within the Outcomes4Me app and data in the medical record. The study shows important discrepancies between the medical record and patient self-reported information, shining a light on the need for better patient education and medical records access. The data showed that while 97% of patients said they understood their diagnosis, up to 24% of patients answered I dont know or Im not sure to fundamental questions about their disease characteristics. According to Maya R. Said, Sc. D., founder and CEO of Outcomes4MeTM, There is no doubt that the inaccuracies found in self-reporting suggest a need for improved patient education regarding key cancer characteristics. These findings underscore a problem that all stakeholders here at the SABCS practicing providers and researchers involved in breast cancer need to have top of mind. The burden of improving patients understanding of breast cancer should not be on the patient alone.

    If you are looking for more support, resources, or have additional questions, submit your question using the “+ button on the 4Me tab and clicking on Ask Outcomes4Me in the Outcomes4Me app. Our O4ME clinical care team will do their best to help you find an answer.


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