What is a Clinical Breast Examination?
A clinical Breast Examination (CBE) is a complete physical examination of the patient’s breast by health care professionals. Health care professionals like breast cancer specialist doctor, nurse practitioner, or physician assistant. In an examination of the breast, the Patient has to be undress. Abnormalities of breast-like size, shape, or changes in the skin of breast and nipples are examined by the professionals. Moreover, using the pads of fingers, the examiner gently feels your breast. In the examination, special attention gives to the shape and texture of the breast. In addition to this, the location of the lumps, and whether such lumps are attached to the skin or to the deeper tissues are trying to be diagnosed. The CBE is very helpful for those women, who cannot be examined their breast abnormalities on their own.
Clinical Trials for Breast Cancer Patients
The most critical time for the patients is to tell them about their fatal disease known as Breast Cancer. At this time, many decisions have to taken by the patients about their care and treatment purposes. One of the most important decisions you have to take about the treatment, that will be best for you. Health professionals mentioned a clinical trial for the patient. In this article, we are going to discuss a detailed overview of the clinical trials. Hence, It will help out the patient to decide the treatment that will be best for the cure of this disease.
What are the clinical trials and how they help to make advancements in the Treatment of Breast Cancer?
Clinical trials are carefully controlled research studies that are done with the patients. Hence, it is very beneficial to test the new treatments and techniques whether it is safe or not. The clinical trial made it possible to emerge new advances in diagnosis, prevention, and treatment of Cancer. It is very important to note that, the clinical trial is undertaken only when there is a good reason to believe treatment or tests are better than the one already used.
The focus of Clinical trials are on the following factors:
- new uses of drugs that are already approved by the Food and Drug Administration (FDA)
- Non-Drug Treatments like Radiation therapy
- Medical procedures like the selection of the type of surgery
- Herbs and Vitamins
- Tools that can improve the diagnostic and treatment ways
- Treatment procedure and drugs that can be helpful to reduce pain
- Combination of Treatment and Procedures
The studies of new cancer treatments are conducted by the researchers trying the answer the basic questions.
- Is the treatment helpful?
- What’s the best way to give it?
- Does it work better than other treatments already available?
- What side effects does the treatment cause?
- Are there more or fewer side effects than the standard treatment used now?
- Do the benefits outweigh the side effects?
- In which patients is the treatment most likely to be helpful?
Different Phases of Clinical Trials for Breast Cancer
The conduction of clinical trials for breast cancer treatment usually in distinct phases. In each phase, a certain question has to be answered. It is very important to know about the phases of clinical trials. There are some pros and cons of clinical trials. Now we are going to discuss clinical trials according to the stage in detail.
Phase 0 Clinical Trials
In this phase, studies are done in humans. Due to this reason, this type of study is different from the other phases of clinical trials. Hence, in the future, some patients will probably be asked to join in this kind of study. In this phase, studies are done to find out whether the drugs reach the tumor or not. in addition to this, it also helps to find out how the drug activity in the human body and the cancerous cell response to the drug.
In this study, the patient must have extra biopsies, scans, and blood tests. Contrary to other phases of clinical trials, there is no direct benefit to the patient in this trial. The reason is the low doses of drugs and the lowest risk to the patient. The “Phase 0” is not widely used and limited to a maximum of 20 persons. They are not required part of testing a new drug but are part of an effort to speed up and streamline the process.
Phase 1 Clinical Trials
The purpose of a phase I study is to find the safest way to give a new treatment to patients. The cancer care team closely watches patients for any harmful side effects. For phase I studies, the drug has already been tested in laboratory and animal studies, but the side effects in patients are not fully known. Doctors start by giving very low doses of the drug to the first patients and increase the doses for later groups of patients until side effects appear or the desired effect is seen. The main purpose of a phase I trial is to test the safety of the drug. If a drug is found to be reasonably safe in phase I studies, it can be tested in phase II clinical trial.
Phase 2 Clinical Trials
These studies are designed to see whether the drug is effective. Patients are given the most appropriate (safest) dose as determined from phase I studies. They are closely watched for an effect on cancer. The cancer care team also looks for side effects. Phase II trials are often done in larger groups of patients with a specific cancer type that has not responded to standard treatment. If a drug is found to be effective in phase II studies, it can be tested in phase III clinical trial.
Phase 3 Clinical Trials
Phase III studies involve large numbers of patients. Most often those patients who have just received a diagnosis for a specific type of cancer. Phase III clinical trials may enroll thousands of patients. Often, these studies are randomized, which means that patients are randomly put in 1 of 2 (or more) groups. One group (called the control group) gets the standard, most accepted treatment. The other group(s) gets the new treatment(s) being studied. All patients in phase III studies are closely watched. The study will be stopped early if many patients have side effects from the new treatment that are too severe or if one group has much better results than the others. Phase III clinical trials are needed before the FDA will approve a treatment for use by the general public.
Phase 4 Clinical Trials
Once a drug has been approved by the FDA and is available for all patients, it is still studied in other clinical trials (sometimes referred to as phase IV studies). This way, more can be learned about short- term and long- term side effects and safety as the drug is used in larger numbers of patients with many types of diseases. Doctors can also learn more about how well the drug works and whether it might be helpful when used in other ways (such as in combination with other treatments).