Could Your Patient Benefit? New Clinical Trials in Breast Cancer

Could Your Patient Benefit? New Clinical Trials in Breast Cancer

A number of phase 3 studies in breast cancer have opened in recent months. Maybe one of your patients could benefit from being enrolled?

Advanced HER2+ breast cancer. Patients with previously treated advanced or metastatic HER2+ breast cancer with and without brain metastases are sought for the DESTINY-B12 trial of trastuzumab deruxtecan (Enhertu). Patients will be treated for approximately 2.5 years, depending on the time to progression or death. Recruitment began on June 22, with the aim of recruiting 500 patients globally; US sites are in Massachusetts, North Carolina, and Virginia. Overall survival (OS) and quality of life (QoL) will be tracked. More details at clinical trials.gov

This is an important study, says Medscape contributor Kathy Miller, MD, professor of oncology and medicine at the Indiana University School of Medicine, Indianapolis. “If positive [it] will change the standard of care and expand options for that subgroup of patients,” she said.

Locally recurrent or metastatic HR+, HER2- breast cancer. Patients with locally recurrent inoperable or metastatic HR+, HER2- breast cancer eligible for chemotherapy are being recruited for the KEYNOTE-B49 trial, which will look at adding pembrolizumab (Keytruda) onto chemotherapy. Patients will receive therapy for up to 2 years. Progression-free survival is the primary outcome measure, with OS and QoL as secondary measures. More details at clinical trials.gov

“This study is based more on hope than preliminary data,” Miller said. “While immunotherapy has had some benefit in triple negative breast cancer (TNBC), there is little data to support benefit in ER+ disease. It would be great for our patients if I am wrong about this one.”

Locally advanced or metastatic HER2+, PD-L1+ breast cancer. Patients with locally advanced or metastatic HER2+, PD-L1+ breast cancer are sought for KATE3which is testing trastuzumab emtansine (T-DM1, Kadcyla) with atezolizumab (Tecentriq). Study sites are in California, Georgia, Missouri, New Mexico, New York, and Pennsylvania. Patients will be treated “until disease progression, unmanageable toxicity or study termination by the sponsor.” This is the only trial in the list for which OS is a primary outcome; clinically meaningful QoL will also be logged. More details at clinical trials.gov

HR+, HER2- breast cancer. Premenopausal women with HR+, HER2- breast cancer, and men with HR+ breast cancer are being sought for the OVELIA trial, which is testing a new subcutaneous formulation of leuprolide acetate, known as TOL2506. All patients will receive the new product for the 48 weeks of this single-arm trial. After that period, patients can get expanded access until the drug is commercially available. Study sites are in Illinois, Kansas, Kentucky, and Michigan. The study outcome is suppression of ovarian function; researchers will not assess QoL or OS. More details at clinical trials.gov

ER+, HER2- early breast cancer. Patients with medium- or high-risk ER+, HER2- early breast cancer are sought for the lidERA Breast Cancer study. This trial, based in California, Kansas, Montana, and Nevada, is looking at giredestrant, a new selective estrogen receptor downregulator (SERD). This oral therapy is a potential alternative to monthly intramuscular fulvestrant (Faslodex), the only SERD currently available in the United States. Patients will be treated for up to 5 years or until disease recurrence. The trial will measure OS and QoL, as well as the primary outcome of invasive-disease-free survival. More details at clinical trials.gov

HR+, HER2- metastatic breast cancer. Patients with HR+, HER2- metastatic breast cancer who have not progressed during first-line treatment with an aromatase inhibitor and a CDK4/6 inhibitor are sought for the SERENA-6 trial. The trial is testing a new oral SERD (known only as AZD9833) in a protocol that is described by the sponsors as a “ctDNA-guided early-switch study.” Patients will be monitored for the development of an ESR1 mutation, a measure of acquired resistance to hormone therapy, and then switched to the study drug to see if it improves response. Patients will be treated until disease progression or death, whichever occurs first. The trial will also measure OS and QoL. More details at clinicaltrials.gov

Breast Cancer Facts

 

    • Approximately 2,200 men are diagnosed with breast cancer.
    • 63% of breast cancer cases are diagnosed at a localized stage.
    • Every 2 minutes, a woman in the United States is diagnosed with breast cancer.
    • 1 in 8 women will develop breast cancer in the US.

Source: National Breast Cancer Org

Breast Cancer Awareness

OCT_Breast_Cancer

Breast Cancer Awareness

This October, we are raising awareness for National Breast Cancer Awareness Month. Breast cancer is when malignant cells form in the breast tissue. The exact cause of breast cancer is not known. This month we want to raise awareness for early detection, possible causes, and treatment.

Most breast cancer symptoms are visible signs but still need professional screening for a diagnosis. Some early/visible symptoms include a lump on the breast, nipple discoloration, or nipple discharge. If you detect any of these symptoms, we suggest you seek healthcare professional.


To date, the cause of breast cancer is still unknown. There might be genetic factors that come into play. The TNM (tumor, lymph node, metastasis) system helps health professionals figure out the breast cancer stage of each individual. Generally, there are five types of treatments. It often includes a combination of chemotherapy, surgery, radiation, and targeted therapies.

Join us this October to raise awareness and support breast cancer patients and survivors.

Big Data Helps Identify Better Way to Research Breast Cancer’s Spread

Big Data Helps Identify Better Way to Research Breast Cancer’s Spread

Scientists are using a lot of genomic data to identify medical issues sooner in patients, but they’re also using it to assist their scientific counterparts in researching diseases better.

In a new study, Michigan State University researchers are analyzing large volumes of data, often referred to as big data, to determine better research models to fight the spread of breast cancer and test potential drugs. Current models used in the lab frequently involve culturing cells on flat dishes, or cell lines, to model tumor growth in patients.

The study is published in Nature Communications.

This spreading, or metastasis, is the most common cause of cancer-related death, with around 90% of patients not surviving. To date, few drugs can treat cancer metastasis, and knowing which step could go wrong in the drug discovery process can be a shot in the dark.

“The differences between cell lines and tumor samples have raised the critical question to what extent cell lines can capture the makeup of tumors,” Bin Chen, senior author and assistant professor in the College of Human Medicine, said.

To answer this question, Chen and Ke Liu, first author of the study and a postdoctoral scholar, performed an integrative analysis of data taken from genomic databases including The Cancer Genome Atlas, Cancer Cell Line Encyclopedia, Gene Expression Omnibus, and the database of Genotypes and Phenotypes.

“Leveraging open genomic data to discover new cancer therapies is our ultimate goal,” Chen, who is part of MSU’s Global Impact Initiative, said. “But before we begin to pour a significant amount of money into expensive experiments, we need to evaluate early research models and choose the appropriate one for drug testing based on genomic features.”

By using this data, the researchers found substantial differences between lab-created breast cancer cell lines and actual advanced, or metastatic, breast cancer tumor samples. Surprisingly, MDA-MB-231, a cancer cell line used in nearly all metastatic breast cancer research, showed little genomic similarities to patient tumor samples.

“I couldn’t believe the result,” Chen said. “All evidence pointed to large differences between the two. But, on the flip side, we were able to identify other cell lines that closely resembled the tumors and could be considered, along with other criteria, as better options for this research.”

The organoid model was found to most likely mirror patient samples. This newly developed technology uses 3D tissue cultures and can capture more of the complexities of how tumors form and grow.

“Studies have shown that organoids can preserve the structural and genetic makeup of the original tumor,” Chen said. “We found at the gene expression level, it was able to do this, more so than cancer cell lines.”

However, Chen and Liu added that both the organoids and cell lines couldn’t adequately model the immediate molecular landscape surrounding a tumor found at different sites in the body.

They said knowing all these factors will help scientists interpret results, especially unexpected ones, and urge the scientific community to develop more sophisticated research models.

“Our study demonstrates the power of leveraging open data to gain insights on cancer,” Chen said. “Any advances we can make in early research will help us facilitate the discovery of better therapies for people with breast cancer down the road.”

Source: Drug&DiscoveryTrends

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Sexual Health Facts

Sexual Health Facts

  • Most STIs have no symptoms – getting tested is the best way to know if you have one.
  • Sexual health is more than just physical- it also involves mental and emotional wellbeing.
  • A person living with HIV that takes their medication consistently and has an undetectable amount of HIV in their blood cannot pass it on to their sexual partners.
  • Condoms (latex, polyurethane, internal [female]) are the only effective contraceptive that helps protect against pregnancy and STIs.

Source: WHO, Healthcare.org

Sexual_Health-1

Sexual Health Awareness Month

Sexual Health Awareness Month

The World Association for Sexual Health (WAS) celebrates on September 4th awareness and is an opportunity to promote safe sex. Sexual Health Awareness Month is an opportunity to highlight the importance of safe sex and how to stay healthy. Sexual health goes beyond an unplanned pregnancy or avoiding a disease. Sexual health is understanding your body and knowing what is important for one’s body. The WHO has several factors that define sexual health:

  • An environment that promotes positive views of sexuality
  • Access to sexual health education
  • Knowledge of the risks of having unprotected sex
  • Access to sexual health care

Sources: WHO, WAS

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Sexual Health Awareness Month

Sexual Health Awareness Month

September is Sexual Health Awareness Month, and it’s an annual occurrence organized by the ASHA to spread awareness and non-stigmatized knowledge towards one’s sexual health. It is important to note that sexual health can mean different things for each individual and does not stop at avoiding STDs/STIs or unwanted pregnancies. Instead, it extends to the overall health and wellness of individuals, couples, families, and economic & social policies throughout the world. ASHA defines sexual health as having the “ability to embrace and enjoy our sexuality throughout our lives” and recognizing that it is an important aspect of one’s physical and emotional health. Being sexual healthy also includes

    • Understanding that sexual health involves respect, safety, and freedom from discrimination and violence.
    • Recognizing that everyone has sexual rights and respecting them (and recognizing them as being part of human rights).
    • Making an effort to ensure everyone has access to non-stigmatized sexual health information, education, and care.
    • Having secure and good-quality information towards the topics of sex, sexuality, relationships, and sexual health.
    • Living in an environment that promotes sexual health and non-stigmatized knowledge (or creating such an environment for yourself and others).
    • Understanding that sexual health is part of life and that it goes beyond sexual activity. This also means recognizing that one does not only have to be in their reproductive years to take an interest in their sexual health.
    • Having the freedom to experience sexual pleasure, satisfaction, and intimacy when the individual desires it.
    • Being able to openly communicate about sexual health with others. This includes sexual partners, people you trust, and healthcare providers.
    • Being aware of how sexual health is influenced by gender norms, roles and expectations, and power dynamics.
    • Understanding that sexual health needs to be approached with an understanding of the social, economic, and political contexts.

All-in-all, even though we have come a long way from the past, there is still lots of stigma and myths that surround the topic of sexual health. We must all help in the effort of spreading awareness- and take a positive approach towards sexuality, health, and sexual relationships. We must also collectively work together to address issues involved within social, economic, and political aspects. After all, sexual health should be a topic that is free of coercion, fear, discrimination, stigma, shame, and violence.

These are some ways you can ensure that you are taking care of your sexual health:

Understanding and establishing your value and knowing what feels good/right for you.

Sex is a natural part of life, and whether you want to engage in it is up to you. It is crucial that your decisions to participate in sexual activity line up with the goals and wants you to have in life. Your choice (if you choose to be sexually active) should be based on your personal goals, desires, and boundaries. Take the time to establish what you are okay with doing and what your limits are. It is also essential to understand that these things may change throughout your life, and that is okay!

Work to educate yourself about your body and how you can protect it and practice self-love.

It is important that you understand your own body functions and have a space to safely explore your sexuality. Take the time to establish your boundaries and educate yourself on how to practice safe sex to protect yourself against STIs/STDs and unplanned pregnancies.

Having a positive view of your body is also part of being sexually healthy. Of course, we don’t expect everyone to just automatically love everything about themselves- but there are many activities and resources that can help you reach body neutrality and even body positivity. The entire point is to do things that bring joy into your life and ultimately help you attain a positive outlook on your sexual health.

Treat partners with respect and expect that they will treat you with that same respect.

Seek partners and relationships that make you feel safe, secure, and comfortable. All boundaries and limits should be respected, and 100% verbal consent is crucial.

Work on building positive relationships.

Actively participate in having open and honest conversations about your relationships, desires, boundaries, and sexual health. Communication and transparency can go a long way in building a positive relationship with your partner (whether they be more committed or just causal). Any problems that either individual may have should be discussed openly and calmly. If you find yourself in a situation where the relationship is detrimental and violent, we encourage you to seek help. Talk to your health care providers, friends, family members, and other organizations within your community. You can also seek help from the National Domestic Violence Hotline.

Make sure sexual health is a normal part of your health care routine.

Your overall physical and emotional health are important aspects when it comes to your sexual health. We encourage you to choose a provider that makes you feel respected and comfortable discussing any questions or concerns you may have about your sexual health. Some other things to keep in mind are:

    • If sexually active, it is recommended that you also get tested for any STIs/STDs just to be safe.
    • Remember to schedule your breast exam or a pap test.
    • Do a regular self-breast exam every month to look and feel for any changes.
    • Speak to your doctor if you have issues with pain, mental/emotional health, libido or energy, etc.
    • Keep track of your hormones and physical wellness.
    • Discuss with your doctor any issues, concerns, or questions about fertility or menopause.

Having proper protection when engaging in sex.

Make sure protection is worn properly and correctly to ensure that everyone involved can be protected from STIs and/or unwanted pregnancies. Understand all the options for contraceptives. Have an open conversation with your partner to decide the best/preferred method for each individual. 

Opening conversations that step away from traditional binary views.

As we move forward, gender identity is moving away from the traditional binary view, and it is becoming more inclusive for people of all sexual and gender identities. Many factors must be considered when it comes to developing an all-inclusive approach towards sexual health. This includes a range of topics from sexual transition treatment to mental and physical health to relationships with others. Having a discussion on these topics with a trusted physician or partner(s) can help you in your path of sexual health, awareness, and empowerment that suits your identity and needs.

CONSENT!

As we have discussed before, sexual health is not only about the physical aspect. It is also about emotional health, communication, and mutual consent. Consent means that each partner clearly communicates to the other if they want to engage in any form of sexual activity and establish their limits/boundaries. One must also ensure that each partner is of the legal age for consent. Communication is crucial- and it is essential to understand that consent can be revoked at any moment (and you have to be ready to respect that decision). Sexual activity performed on anyone without consent, under the legal age of consent, or against someone’s will is abuse/assault. If you or a loved one has gone through this situation, reporting it to the authorities is a step that can lead to justice. If that is too difficult, we recommend you reach out to a trusted friend, family member, or organization within your community. You can also call the National Sexual Assault Hotline for further help. We must all do our part to ensure that everyone’s sexual health and freedom thrive in a positive environment free of coercion, discrimination, and violence.

Sources: ashasexualhealth.org, who.int, & midwestexpressclinic.com

Aging concept. Comparison of young and old. Real result achieved with work of professional makeup artist. Not CGI.

Healthy Aging Month

Healthy Aging Month

This September is Healthy Aging Month! As we all know, we all inevitably age (both mentally and physically) as we progress through our life. Unfortunately, society sometimes enforces myths of what it means to age. We tend to believe that as we get older, it is inevitable that we will grow frail, that we will face cognitive decline, that depression and loneliness are expected, or that we can’t pursue new things. Because of these myths, many negative attitudes and feelings of sadness/fear have formed around the idea of getting older. This is why this event was created in the first place. September is the month where many organizations get together to annually raise awareness on the positive aspects of growing older. Just because one grows older does not mean that we must neglect our health- or fall into these negative stereotypes. 

At Febo, we believe that it is crucial for many people to recognize the importance and beauty of aging. We also believe that it is essential to remind people to take this time to look within their lives and reassess some things. It is never too late to reinvent yourself, take control of your health, or start a new hobby/adventure in your life. Take this time to focus and/or improve your overall health and well-being. Pursue a goal that you always dreamed of achieving. The main idea is that you take a proactive approach to ensure that you follow and live a healthy, happy, and vigorous life.

Here are a few activities you can take up in celebration of this month:

Start an Exercise Routine.

Whether it’s doing yoga in the comfort of your home, going to the gym, joining a class, following a YouTube video, or simply taking a walk around your neighborhood, it is never too late to begin a new exercise endeavor. Make sure to choose something that piques your interests. The overall goal is to find ways to move your body in ways that bring joy to your life (thus increasing the chance that you will stick with this new routine). In doing so, you would be improving your overall physical and mental health.

Schedule some time for self-care.

Taking care of your mental and emotional health is just as important as taking care of your physical health. It doesn’t have to be something elaborate. It can be as simple as making sure you have good food, regular physical activity, keeping yourself hydrated, brushing your teeth, or getting plenty of sleep. You can even simply take the time to recite affirmations, journal, listen to music, take a relaxing bath or shower, or take a break from technology. The point is that you make time (daily or even just weekly) to focus on yourself and release all the stress of life. 

Start a new hobby.

You can begin drawing, painting, playing an instrument, knitting, embroidering, gardening, hiking, cooking- the possibilities are endless. It is never too late to learn and start a new hobby. Choose something that interests you (or something you have always wanted to learn and never had the time or courage) and get started!

Learn how to make new healthy and exciting meals.

Healthy eating does not only mean diet and restriction. Learning how to cook new meals can be very fun and can lead to you discovering various nutrient-dense foods that you enjoy. In the long run, the quality and variety of food you incorporate into your diet can help improve how you feel overall. Cooking can also be a fun activity that can help pass time or open an opportunity to socialize with others.

Keep connected with friends and families, or join different groups for certain activities.

Sometimes our responsibilities in life keep us from spending time with friends and family. Thus, it is fundamental that you take this moment to plan out time dedicated for your family and friends. The pandemic has even made it easier for us to use various technologies to keep in touch with others. You could also volunteer somewhere or take a class to learn a new skill/hobby. Find and plan different ways to ensure that you engage in social activities with others. It can do wonders for your mental health!

Find activities that stimulate your brain.

It is important that you find ways to stimulate your brain. Finding activities to keep your mind active can help improve your memory, help you learn a new skill, improve your problem-solving skills, and it reduces the risk of Alzheimer’s disease and cognitive decline. Exercise is a great way to stimulate the brain, but you can also engage in brain-training games. This includes activity books such as crossword puzzles, sudoku, adult coloring books, word search puzzles, and more. Also, you can go into the app store and download a few apps that interest you. Thus, you can conveniently use any free time you may have to quickly play a brain-training game on your phone. Select a time in the day where you have free time to sit and complete at least a page or a game round!

Make sure that you are on top of all your appointments.

Staying on top of your health is very important. Take this time to discuss with your health care provider to ensure that you are on top of all your annual checkups and health screenings.

No doubt- as we age- we may face a new set of challenges within our life. However, it is wrong to assume that everyone’s quality of life will inevitably diminish. We encourage you to take control of your life and take action in finding ways to live a healthy and positive lifestyle. It is never too late to engage in new activities or to make positive changes towards your health. Don’t believe all the myths you hear about aging, and don’t let them instill fear or weariness. There is beauty and strength in the journey of getting older, don’t allow the myths to close the doors on the enjoyment you can create in your life.

Source: news.nnlm.gov

Overdose

International Overdose Awareness Day

International Overdose Awareness Day

August 31st is International! It is a time to raise awareness of drug overdose and remember those who have died or suffered permanent injury – and acknowledge the grief of their family and friends. Overdose is known to be one of the world’s worst public health crises. According to the CDC, over 81,000 drug overdose deaths occurred in the US in the past 12 months from June 2019-May 2020 (which is the highest number ever recorded). The CDC also points out that synthetic opioids are the primary cause for the increase in overdose deaths. Deaths from opioid overdose have increased 38.4% in the past 12 months. Overdose deaths involving cocaine also increased by 26.5% (research points out that this is most likely due to contamination of cocaine with fentanyl or heroin). 

It is crucial to be aware that a range of signs and symptoms can occur when a person overdoses, and everyone will respond differently. You shouldn’t only call an ambulance if someone is unconscious. Other signs to look for is if the person is experiencing any of these symptoms: 

  • A seizure  
  • A severe headache  
  • Chest pain  
  • Breathing difficulties  
  • Extreme paranoia, agitation, and/or confusion  

Make sure to stay with the person and assure them if they are conscious. If unconscious, turn them on their side to prevent them from choking on their vomit. Continuously monitor the person until help arrives. Don’t ignore snoring or gurgling cause this may indicate that a person is having trouble breathing.  

Overdose and addiction have always been serious issues. However, the spread of awareness this year is crucial because the situation is increasingly becoming worse. While overdose numbers were already increasing during 2019, it appears that the COVID-19 pandemic led to an acceleration of overdose deaths. The pandemic disrupted everyone’s daily life, and we all had to adjust to a “new normal.” However, the pandemic also had a significant impact on those struggling with substance use disorder. After all, the pandemic not only changed our lives in a physical sense, but many of us also had to face challenges with our mental health. The pandemic led to many people feeling stressed (both in a personal and economic sense) and isolated. These feelings can be harmful to those struggling with addiction because they may engage in substance use to deal with these feelings. The feeling of isolation and scarcity of obtaining drugs have also contributed to the risk of overdose.  

Thus, it is a significant time to honor and remember those who lost their lives or have been severely impacted by their substance use disorder. Also, remember that this may be the first time family members may be openly mourning their loved ones. We should respect and provide a safe environment for families to grieve and mourn without having to feel guilt or shame. Many of those who have suffered from overdose and addiction may also find this day triggering. We encourage those struggling to take time for themselves and maybe reach out to anyone who will listen (a medical professional or family and friends). Know that you are valued.  

August 31st is also a crucial time we can collectively come together as a society and make an active effort to discuss and work towards better evidence-based overdose prevention and drug policy. You can start by: 

  • Showing your support by actively participating in events and campaigns 
  • Hold an event in your community 
  • Post a tribute to loved ones who have died or who have suffered permanent injury to overdose 
  • Engage with other platforms and reliable sources on social media to gain more information  
  • Hold a candlelight vigil 
  • Reach out to anyone who may be struggling during this time  
  • Support and donate to organizations that work to treat and prevent the disease of addiction 
  • Open the doors to informative discussions about substance use disorder and drug overdoses  

We can all begin by educating ourselves and encouraging those with the knowledge to educate others. The more conversations we have about this issue, the more impact and difference it can have on breaking stigmas around drug-related deaths and substance use disorder. It is important to remember that anyone can be affected by an overdose, not just a specific group of people. If we work towards breaking these stigmas and forming better research-based approaches to overdose and drug policy, society can provide individuals suffering from addiction better help and support in their journey of getting better.  

While the pandemic may have worsened the opioid epidemic, it has also brought positive changes to this issue. Because of the pandemic and lockdown, Telehealth is a positive development that has emerged during this time. It gives people struggling with substance abuse and addiction another accessible way of reaching out for help without traveling to a specific place. Also, as society has more open and informative conversations around this issue, awareness is being raised, and the stigmas around this issue are being dismantled. There is still lots of work that needs to get done. However, these conversations are making a huge impact and allowing society to take significant steps forward. While this is a day filled with grieving, it is also a day filled with hope for the positive changes that will continue to emerge in the present and future.  

As we take this time to spread awareness of drug overdose, it is important that everyone makes a collective effort to learn more about this topic. If you or a loved one is suffering (or if you want to learn more about this topic), we recommend you look into these resources for further information and guidance: 

We also encourage anyone struggling with a substance use disorder to reach out to their physician, other health professionals, support groups, family, and friends. We are all in this together, and we will all work to overcome this crisis.  

Sources: overdoseday.com and cdc.gov