Study of Combination Therapy in The Treatment of Recurrent Breast Cancer - Free Essay Example

Sample details Pages: 5 Words: 1505 Downloads: 1 Date added: 2019/02/06 Category Medicine Essay Level High school Tags: Breast Cancer Essay Did you like this example? Trial background Breast cancer is a disease in which cells in the breast grow out of control. There are different kinds of breast cancer. The kind of breast cancer depends on which cells in the breast turn into cancer. Don’t waste time! Our writers will create an original "Study of Combination Therapy in The Treatment of Recurrent Breast Cancer" essay for you Create order Breast cancer can begin in different parts of the breast. A breast is made up of three main parts: lobules, ducts, and connective tissue. The lobules are the glands that produce milk. The ducts are tubes that carry milk to the nipple. The connective tissue (which consists of fibrous and fatty tissue) surrounds and holds everything together. Most breast cancers begin in the ducts or lobules. Breast cancer can spread outside the breast through blood vessels and lymph vessels. When breast cancer spreads to other parts of the body, it is said to have metastasized. Kinds of Breast Cancer The most common kinds of breast cancer are: Invasive ductal carcinoma. The cancer cells grow outside the ducts into other parts of the breast tissue. Invasive cancer cells can also spread, or metastasize, to other parts of the body. Invasive lobular carcinoma. Cancer cells spread from the lobules to the breast tissues that are close by. These invasive cancer cells can also spread to other parts of the body. There are several other less common kinds of breast cancer, such as Paget’s disease, medullary, mucinous, and inflammatory breast cancer. Ductal carcinoma in situ (DCIS) is a breast disease that may lead to breast cancer. The cancer cells are only in the lining of the ducts and have not spread to other tissues in the breast. Breast cancer is treated in several ways. It depends on the kind of breast cancer and how far it has spread. People with breast cancer often get more than one kind of treatment such as surgery, biological therapy, hormonal therapy, radiation therapy but our clinical trial concern is Chemotherapy which is Using special medicines to shrink or kill the cancer cells. The drugs can be pills you take or medicines given in your veins, or sometimes both. The study purpose is to evaluate the efficacy and safety of Cabozantinib+Lynparzal for the treatment of breast cancer using Chemotherapy. Based on phase II clinical trial results showing that 250mg/kg Cabozantinib and Lynparzal were safe and effective in the treatment of breast cancer, the phase III the clinical study is to further verify the efficacy and safety of Chemotherapy using Cabozantinib and Lynparzal for Breast cancer Trial Objectives: The study primary objective is to evaluate the efficacy and safety of Cabozantinib+Lynparzal for the treatment of breast Cancer compared tousing placebo plus Lynparzal as the control. The evaluation of the therapeutic effect of the chemotherapy will be done by a comparison between the participants that received Cabozantinib and Lynparzal and the participants that received the placebo plus Lynparzal. At baseline, measurable tumor lesions will accurately be measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of:10 mm by CT scan (irrespective of scanner type) and MRI (no less than double the slice thickness and a minimum of 10 mm) per RECIST 1.1 10 mm caliper measurement by clinical exam (when superficial) per RECIST 1.120 mm by chest X-ray (if clearly defined and surrounded by aerated lung) per RECIST 1.1 Secondary objectives: Change from baseline in tumor lesions measured at Week 12 of combination therapy with Cabozantinib (administered once a day) and Lynparzal vs. placebo plus Lynparzal per RECIST 1.1 Clinical Benefit Rate: [ Time Frame: 12 weeks]CBR will be determined by looking at the number of subjects who have either a complete response, partial response, or stable disease for greater than or equal to 12 weeks, per RECIST 1.1 Time to clinical worsening during combination therapy with Cabozantinib and Lynparzal vs. placebo plus Lynparzal where clinical worsening is defined by liver cirrhosis due to breast cancer, death due to breast cancer, hospitalization for breast cancer worsening, any early discontinuation from study due to Chemotherapy. Overall Response Rate per Immune Criteria: [ Time Frame: 12 weeks]. ORR will be determined according to immune-related response criteria (IRRC). Number of participants with adverse events [ Time Frame: ] Toxicities will be defined according to NCI CTCAE, Trial Design: Design principle: This is a parallel, placebo-controlled, double-blinded and multicenter clinical trial. The subjects are randomized into trial group and control group at 3:1 ratio in this phase III clinical trial. The subjects will be assigned to a trial group or control group by stratified block randomization to receive not more than 2 courses of treatment. The control group receivesd placebo during the first course of treatment followed by a trial drug during the second course of treatment. Based on phase II clinical trial results, the trial drug dose is set at 250mg. 3.2 Sample Size Statistical estimation of the sample size: using two-sided test of the efficacy, ?=0.05 and ?=0.1(power=90%) based on phase II clinical trial results, the expert estimates the total clinical efficacy rate of Cabozantinib+Lynparzal to be 65% in the treatment of Breast Cancer and expects a 30% difference from the placebo group; consequently, the estimated number of participants 625, we approximated to 640 . Taking into account a dropout rate of 20% as per another study, the sample size of this clinical trial was determined to be 600 subjects for the trial group and 200 subjects for the control group, giving a total of 800 subjects. Design principle Trial arm and number of Participants Dosage of Cabozantinib+Lynparzal Trial period Randomized, double-blinded, placebo and parallel-controlled (multicenter) 600 participants in trial arm 250mg The first courseof treatment Randomized, double-blinded, placebo and parallel-controlled (multicenter) 200 participants in control arm 0mg The first course of treatment Randomized, double-blinded(multicenter) 600 participants in the trial arm 250mg The second course of treatment Randomized, double-blinded(multicenter) 200 participants in control arm 250mg The second course of treatment 3.3 Randomization In this randomized and double-blinded trial, each subject should be assigned a drug serial number strictly in accordance with the inclusion time sequence to determine the treatment group. Stratified block randomization was performed, and a software analysis system is used to generate continuously serial numbers corresponding to the sample size. The randomization numbers for each study center are generated at the same time. 3.4 Subject selection The participant is capable of understanding and complying with the protocol and has signed the informed consent document. The study population will consists of female patients 25 years and older. 3.4.1 Inclusion Criteria Participants must have histologically or cytologically confirmed invasive breast cancer, with metastatic disease with Lynparzal. Participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation. Participants must have measurable disease by RECIST version 1.1 Prior chemotherapy: Participants may have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer and must have been off treatment with chemotherapy for at least 14 days prior to registration. Participants should also be adequately recovered from acute toxicities of prior treatment. Prior biologic therapy: Patients must have discontinued all biologic therapy at least 14 days prior to registration. In all cases, there must be complete recovery and no ongoing complications from prior radiotherapy. 3.4.2 Exclusion Criteria Those who have recent health conditions like surgery which involves wound healing. No clinically relevant ongoing complications from prior surgery are not eligible. The participant has a tumour in contact with, invading, or encasing major blood vessels or radiographic evidence of significant cavitary pulmonary lesions. The subject has pathologic evidence of a tumour invading the GI tract (oesophagus, stomach, small or large bowel, rectum or anus), or any evidence of an endotracheal or an endobronchial tumour within 28 days before the first dose of the trial drug. Concurrent administration of other anti-cancer therapy within 14 days of starting protocol therapy and during the course of this study. The participant has received another investigational agent within 14 days of the first dose of study drug. The participant has received a prior c-Met inhibitor Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: Cardiovascular disorders including: The participant is unable to swallow oral dosage forms. The participant is pregnant or breastfeeding 4.0 Treatment Administration Lynparzal is given to participants given every 2 weeks intravenously the dosage as determined by the phase II trial is 150mg. Cabozantinib is administered orally once daily to all participant in the treatment group the dosage is 250mg The Control Placebo is designed in the same way as Cabozantinib and the Lynparzal with the same dosage and same administration method. 4.1 Concomitant drugs The participants are not allowed to use the drugs listed in the exclusion criteria during this trial. If concomitant drugs are indeed needed to treat other diseases, the name, dosage, indication, the beginning and ending date, and other relevant information should be recorded in the case report form (CRF) 4.2 Multi-Center and the number of participants The total number of subjects, grouping, randomization method and the tasks undertaken by each centre .The total number of subjects planned to include is 800 and the distribution of these subjects among the centres are listed in the following table.

The Lack of Womens Sports Coverage Essay example

The Lack of Womens Sports Coverage Can womens sports establish itself as a topic of on-going media and journalism curiosity? Currently TV stations do minimal coverage of womens sports, while newspapers and magazines do just a little bit better. In a recent interview with Gary Webb, a sports writer for The Spectrum, he says that the people have demonstrated that there is an audience that loves hearing about women athletes. After all, they are somebodys kids, sisters, and moms. I learned that these sports writers love to cover womens games, especially girls highschool basketball games. Gary said that he would rather watch a Parowan-Beaver girls game over the boys anyday. Karen Winegar, staff writer for the The Star†¦show more content†¦In 1926, Gertrude Elderly became the first woman to swim The English Channel freestyle. Five other men had done that before her, but Gertrude broke the record of swimming the 35 miles in 14 hours and 31 minutes, two hours less than that of the record holder. The state of New York had a celebration for her accomplishment. Can you imagine what the media and journalism coverage would have been like for Gertrude? If that same instance were to happen today, I would imagine that journalists and sports casters wouldnt be too interested because it was only the English Channel, and people today are swimming across oceans. As you can see, womens sports have been around for sometime and are continually increasing in popularity. As for the coverage of these sports, something needs to be done. In 1993, 94 percent of mens sports got the attention, womens sports five percent, and gender neutral one percent (1A+). In-depth coverge of organized womens sports such as golf, tennis, running, and basketball was minimal. 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We live society were male dominance is the order of the day, from the family arena to the workplace, and in sports in which individuals with certain characteristics and attributes as seen as normal and the rest are termed as the â€Å"other†. This paper will focus on how hegemonic masculinity has been mediated through the media, by creating gender gaps. FurthermoreRead MoreTitle IX was put in place to help women. This act was supposed to stop situations such as unfair700 Words   |  3 Pagesarticle Media Coverage of Womens Sport: A New Look at an Old Prob lem, â€Å"There is evidence that these injustices are not diminishing over time, as Duncan and Messner (2000), in their longitudinal analysis, found the amount and type of coverage of womens sport in broadcast media has not changed since 1989† (Cunningham 44). The problem of inequality within media has been a problem for years and there haven’t been improvements. 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Strategies for Growth and Excellence

Question: Discuss about the Strategies for Growth and Excellence. Answer: Introduction: Nokia 3310 was a GSM mobile phone that was launched in 2000 and had discontinued in the year 2005[1]. It was an iconic phone and a total of 126 million units have been sold and had changed the whole mobile phone industry. During the time, this mobile piece had several features that are new in the mobile industry like- Nokia network monitor, calculatorand stop watch along with a reminder function1. However, after 17 years the Nokia 3310, worlds most beloved phone finally gets an official release date[2]. Though, I think this topic can be a good topic for debate- whether people purchase this new and developed Nokia 3310 in the era of Smartphone. Nokia provide features like 1.5-inch color screen, 2.5G network, facility of 1 month standby time, 1 day of talk time and snake in their developed Nokia 33102. However, most of the people will not prefer to purchase this product due to lack of essential features like Wi-Fi, 4G, app store, Android OS and major application like Facebook, WhatsApp and YouTube. Moreover, I think that people can use this phone as a secondary mobile device that can be used for emergency. Furthermore, I would like to say that Nokia have also planned for competing with contemporary Smartphone companies by developing Nokias flagship Android Smartphone. Additionally, another aspect of debate is the sustainability of the Nokia mobile phones. In this case customer should evaluate whether this device use less energy, efficient recharge process, no use of the toxic or hazardous materials and whether the material can be recycled or not. It is found that Nokia utilizes their new designs concepts like- carbon-based g raphene, nano technology and flexible displays for exploring their advanced technologies division[3]. Nokia have also developed a department, which recycled mobile phone on request by user and thus it is believed by the customers that the organization have used recyclable product for developing Nokia 3310 and other new series that they desire to launch in coming days. The Nokia 3310s packing is smaller in size minimize paper use and the mobile device is free from free of PVC, Nickel and brominated flame retardants (BFR). Managing authorities also says that this model a very low radiation and battery saving options in order to formulate a durable phone by following environmental concern. Thus these materials can be renewed easily. Moreover the android phones also use this technology and has an automatic screen brightness adjustment that saves energy. This technology will attract more fans of Nokia 3310. In this way, both the environmental concern and customer base can enhance. So, there is a chance for Nokia user to buy this phone but still a majority of people will prefer smart phones over this concerned model. Thus, I can say Nokia always values for the recent demand and nostalgia of its customer and it can be seen from their launching of Nokia 3, 5, 6 and 8 and re-launching of Nokia-3310. Reference List Kharpal, Arjun. 2017. "After Nokia 3310 Relaunch, Lenovo CEO DoesnT Rule Out Iconic Motorola Razr Return".CNBC. https://www.cnbc.com/2017/02/28/motorola-razr-return-lenovo-ceo-nokia-3310-relaunch.html. Motorola.Com. 2017."Motorola UK | Mobile Phones Smartwatches". https://www.motorola.com/. New Nokia 3310: Price, Release Date And Everything We Know. 2017.The Telegraph. https://www.telegraph.co.uk/technology/0/nokia-3310-price-release-date-everything-know/. Nokia.Com. 2017."Browse Nokia Phones". https://www.nokia.com/phones. The Iconic Nokia 3310 Is Back. 2017.Nokia.Com. https://www.nokia.com/en_int/phones/nokia-3310.

Sustainability and Global Warming free essay sample

One According to Herbert Girded (author of Cities People Planet), sustainability enables all its citizens to meet their own needs and to enhance their well-being, without degrading the natural world or the lives of other people, now or in the future (Page 6- Planet). Cities have been at the heart of this question because it is where the human population is at its highest and densest. Just look at the history of human civilizations for example, from Jericho to Rome (Chapter 2), from Beijing to London, and from Hong Kong to New York. What do they all have in common? They are all highly populated cities and most of them are near the coastal regions where pollution and sea levels are rising due to global warming. So given that about 80 percent of the worlds population is expected to live in urban areas by the year 2050, sustainability is an extremely huge concern for our present time and the future. We will write a custom essay sample on Sustainability and Global Warming or any similar topic specifically for you Do Not WasteYour Time HIRE WRITER Only 13.90 / page Should we practice it? Definitely. Sustainability is ethical for our survival, and most importantly, preserving the natural resources and ecosystem of our planet from the destruction of global warming. We have to understand the obligations, values, and uniqueness of sustainability because it is self-apparent as humans to practice sustainability and maintaining a livable planet. We will look at the link between humans, cities, and the natural world, why are we talking about sustainability today. Then we will look at the impact of globalization and global warming on our planet and what we can expect to happen in the future if this trend does not stop. Finally, we will look for possible solutions to our planets current crisis and why we should work towards an ethic of sustainability according to Randall Current (Toward An Ethic Of Sustainability). The author Louis Uniform said 50 years ago: If we would lay a new foundation for urban life, we must understand the historic nature of the city. (Chapter 2) In order for us to understand the link between humans, cities, and the natural world, it helps to understand the history of how it started. The link between humans and the natural world was already apparent from the beginning. The history of human settlements starts with hunter-gatherer bands setting up temporary camps or occupying caves in areas where fruits, nuts, fish, and game were plentiful. From here, villages emerged after wheat and barley had been domesticated in the Elevate around 8,500 BC. Thousands of people lived in one space by growing crops on clearly defined areas of land and fishing the fertile waters of rivers, lakes or the sea. This early settlement exemplified human control of nature through technological innovation, with hoes, ploughs, and sickles used to farm the land and pottery Jars made to store the harvest. The emergence of towns and cities is also the story of complex forms of social organization, with the appearance of formalized political and virtual hierarchies, administrations, writing and military power (Page 24). Subsequently, larger civilizations developed through time. Early cities like Jericho and Octal Yuk emerged. Dating back to about 7,000 BC, Jericho had the worlds earliest city walls, stone staircase, and its sufficient water. At 7,100 BC, Octal Yuk existed tort about 1 years, Witt a 32 acre site, mud brick houses, and a population of about 6,000. There is also much evidence of long-distance trade, cowries shells from the Mediterranean, manganese copper and turquoise from eastern Anatolia and the Sinai. Despite having the necessary ingredients to have a livable city, these early civilizations cease to exist which meaner that they were not sustainable. Why werent they sustainable? Much more excavation work is needed before we can get a clear answer on why those early cities werent sustainable. This transitions us into the impact of modern cities and how it is Jeopardizing the sustainability of our world. The industrial city started to develop in Britain in the 18th century with the introduction of coking coal made it possible to create an unprecedented range and quantity of new metal objects (Chapter 4). In 1781, James Watt started the revolutionary rotary-motion steam engines which led to the powering of factories, trains, ships, and cars. This explosion of industrialization resulted in three things. One, faster population growth than ever before with seven billion people currently and two more billion are expected within the next 25 years. Two, global warming due to more greenhouse gas (most notably carbon dioxide) being produced than ever before. And three, globalization and arbitration that is changing the way we live since most of the world will be expected to live in urban areas in the next 25 years. Furthermore, the world is divided into three different type of countries. The core (rich capitalists), semi-periphery, and periphery countries. Periphery countries grow their raw goods mainly for profit and not to feed their own people which leads to starvation. Then there are the semi-peripheral countries like China, India (both becoming capitalists), South Africa, Russia, and South America which have the factories and cheap labor (invest by core capitalists) necessary to produce raw goods. This translates into the core countries getting the most food while not enough food or the poor periphery and semi-periphery where population growth is faster than ever. This violates the third principle of sustainability: seek fair terms of cooperation conducive to sustainability. Actors whose actions affect each other are obligated to cooperate in negotiating fair terms of cooperation in living in a manner that is collectively sustainable. In other words, there needs to be a cooperation in negotiating a fair terms of sharing the resources so we can maintain sustainability. In addition, this global industrialization equals more energy used, this results in ore carbon dioxide in the atmosphere, which will yield more severe global warming that will wreak havoc on the earths climate change and weather patterns. Ice caps with high labeled are melting faster than before while the ocean (93% of global warming) is absorbing more heat than before. According to Surface Temperature Analysis from NASA, global temperature has warmed at the highest rate at 1. 12 degrees Fahrenheit anomaly in 2010 and is expected to get worse. The asses was the hottest decade on record but the asses were even hotter according to the NRC. The Auks Met Office (National Weather Service) predicted that if we allowed the earths temperature to increase to 4 degrees Celsius then the impact will be catastrophic. A 2-foot rise in the global sea level is expected by the year 2100 while Saracens become more acidic as carbon dioxide emissions in the atmosphere dissolve in the ocean. This acidification will harm the ecosystem (about 60% of ocean life depends on coral ere ) that is sensitive to the pH to the ocean water. The average land temperature will be 5. Degrees above pre-industrial levels, agricultural yields are expected to crease for all major cereal crops in all major regions of production, and half of all Himalayan glaciers will be significantly reduced by 2050, leading to 23% of the Chinese population deprived of the vital dry season glacial melt water source. Furthermore, extreme weather patterns are to be expected such as more hurricane and drought. Global warming may spawn more super-storms As emissions of greenhouse gases continue to trap more and more of the suns energy has to be dissipated, resulting in stronger storms, more intense precipitation and higher winds. This vicious cycle of globalization plus population growth plus global warming ultimately equals unsuitability for our future. Ultimately, the Pentagon predicts that global warming will be biggest concern for this century. It is our obligation to maintain sustainability in our world and apply the first principle of sustainability ethics and that is do not diminish natural capital. There are three things to consider when talking about sustainability of cities. They are economy, environment, and equity of society. The Bedding Zero (Bedded) and Lading Echo- Villages compact urban development are good examples of working towards sustainability. Bedded was created on a Brownfield site, a former sewage works, in the borough of Sutton in South London (Chapter 8). It has many innovative features, including its own combined heat and power system burning wood chips, a pool of electric cars, and photovoltaic panels mounted on the conservatories of every flat. Bedded buildings have very high levels of energy and resource efficiency and greatly reduced running costs. Instead of investing in a central heating system, each flat is insulated by 30 centimeters of rock wool like a giant tea coos. Bedded was constructed form natural, recycled or reclaimed materials. Due to its innovative design, solar energy and heat generated by occupants is sufficient to maintain comfortable temperatures even during winter. The Echo-villages designs features key components like: renewable energy-solar hot water, a central facility of visual and performing arts and culture. A photovoltaic and wind power. Water supply form household rainwater tanks, storm water retention in ponds, sewerage to be treated and reclaimed water used for irrigation on site, and a centralized recycling collection. The most difficult issue is finding a different energy source besides coal since our economy has been relying on it for more than a 150 years. Consequently, our biggest energy user is our cars which emits a lot of carbon dioxide. Some suggestions could be investing in new energy sources such as solar power, geothermal, wind, the use of electric/hybrid automobiles, planting more trees, better sewage and recycling systems, etc. Regardless, societies and their governments should create institutions that are conducive With respect to sustainability. Why should we care about the ecosystem? It is our obligation since we depend on it for food. It is part of our human values because we and other human beings cannot survive without it, and the consequences of it are already apparent in some parts of the world. We must strive for a more sustainable future to save and preserve what is left of the planets ecosystem because our lives depend on it. It is simply our obligation, our values, and the consequences if we do not apply principles of sustainability ethics. That is, to not diminish natural capital and that opportunities to experience the natural world are important to human well-being but not captured by the idea to natural capita must act now or else things will get worse.