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    Breast Cancer Clinical Trials

    Candidates for new drugs are initially tested under the microscope and in lab animals, but the real test for a new drug's effectiveness comes with how well it performs in humans.

    Pharmaceutical research is ongoing with breast cancer drug clinical trials that call for real people to volunteer in medical research. Not everyone qualifies. And, there are risks and benefits you must be made aware of before you sign up.

    Interested? Read the FAQ we have prepared to answer any general questions you may have, or ask your doctor to see if you are a candidate for participating in a breast cancer clinical trial.

    For more details, check out online resources just up ahead for breast cancer clinical trials that may be taking place in your area:



    Clinical Trial FAQ


    How do clinical trials work?


    There are three steps to clinical trials -- called Phase I, Phase II and Phase III. The first step involves a small number of people who are simply tested for how well a new drug is absorbed and metabolized within the body.

    If all goes well, Phase II usually involves a hundred or more people who are tested to see if the new drug has the beneficial outcome researchers are expecting. Phase III involves monitoring side effects, safety, and comparing the effectiveness of a new drug with those already on the market. These final trials may also involve up to thousands of people and last for several years.

    What does"randomized" or "double blind study" mean?

    Many phase II and phase III studies are randomized, meaning that patients are randomly assigned to get either the experimental drug, a standard treatment (if there is one) or a placebo (if there isn’t a standard treatment). A placebo often comes in the form of a "dummy" pill or injection that doesn’t contain any medicine. The use of placebos helps researchers compare the effects of a given treatment against no treatment.

    Usually, phase II and phase III studies are "double-blinded" -- neither the patients nor the researchers know who is getting the experimental drug. This helps to prevent bias on the part of the researcher or the patient.

    What happens during a clinical trial?

    Depending on the drug or their specific goal, clinical trials may occur in a controlled hospital setting or outpatient basis, meaning participants are not required to stay overnight. (Be sure you ask what the trial requires.) In either case, participants are usually assigned a bed and a locker along with books, magazines, TV or free wi-fi.

    Along with the administration of the drug (or a placebo) you may be asked for blood or urine samples, your blood pressure will be monitored, and other tests will be performed on an ongoing basis. You'll also be asked to report on any side effects such as unusual aches, pains, nausea, or other symptoms while undergoing the trial.

    What if I want to quit a clinical trial?

    Before joining a clinical trial, you must be told about the goals, procedures, and potential risks of the trial. You must also, by law, sign an "informed consent" form. But even after signing the consent form, clinical trial patients may withdraw from a study at any time, and for any reason. In addition, as the trial is underway patients are kept informed about anything that may affect their willingness to continue.

    Will I be paid for my participation? How much?

    Participants receive some sort of compensation for their time, travel expenses and parking in most cases. Payment procedures for clinical trials are not standard, so there's no set answer to how much you will be paid. Participants may be paid hundreds, and up to thousands of dollars throughout the length of a particular clinical trial.


    Finding breast cancer drug clinical trials online:

    Center Watch Clinical Trials
    Lists breast cancer drug and treatment clinical trials by US State. Clicking on the trial listing will show you what the study involves and who qualifies.

    Kimmel Cancer Center: Clinical Trials
    Information on treatment options, breast cancer studies and clinical trials of breast cancer drugs and treatments at the Kimmel Cancer Center.

    NCI - National Cancer Institute
    Searches for ongoing drug trials by type of cancer, geographic area, and the type of treatment. Results tell you what conditions qualify for taking part and who they will not accept. Good general information on what clinical trials are to help you decide whether you are interested in taking part.

     

     

     

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