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General Surgery

Clinical Trials

During the treatment of breast cancer, your doctor might approach you to know your interest regarding participation in a clinical trial.

What is a clinical trial?

A clinical trial is a research study on human volunteers performed in order to find new ways to prevent, diagnose, or treat diseases. The best conventional treatment for breast cancer is surgery; however other treatment options such as drugs, radiotherapy, supportive care programs, or complementary therapies may be included in the treatment plan.

Clinical trials are organized under the guidance of trial investigators so that the outcomes of the treatments being studied are carefully monitored. Some trials compare a new treatment with an existing one. The two major advancements in breast cancer clinical trials are breast conservation surgery and sentinel node biopsy.

Why are there clinical trials?

Clinical studies are done with cancer patients to find out the effectiveness of new approaches to cancer prevention, diagnosis, and treatment. An ethics committee made up of physicians, scientists, lawyers, and members of the community must approve and monitor the clinical trial protocol.

Who runs clinical trials?
Clinical trials are run by a group of trial investigators at major universities, hospitals and pharmaceutical companies.

What are clinical trial phases?
Clinical trials are carried out in an orderly sequence of steps called phases. This permits trial investigators to interact and collect reliable information about the drug in order to protect patients. Clinical trials are classified into one of three phases:

Phase I trials: These studies evaluate the various modes of new drug administration, for instance oral (mouth), intramuscular, or subcutaneous. Also, the dose of the drug is monitored. A phase I trial includes very few people, about 10-12.

Phase II trials: These studies concentrate on a specific type of cancer. The phase II trial ensures the safety of the drug and is initiated to assess the efficacy of the new drug.

Phase III trials: These trials experiment a new drug, a new combination of drugs, or a new operative procedure along with the currently available treatment. A clinical trial volunteer will usually be allotted to the standard group or the new group at random. Double-blinded study is a trial in which neither you nor your doctor knows which treatment you are receiving. Phase III trials involve a large number of people.

Phase IV trial involves study to evaluate the side effects, risks, and benefits of a new drug over a longer period of time (several months and years) and in a larger population than in phase III clinical trials.

What are the potential benefits and drawbacks of participating in a clinical trial?
By participating in a clinical trial you may receive a new treatment before it becomes available to the public that may become a standard and effective therapy in the future. Also, you are contributing to medical research that may benefit future generations.

Drawbacks of clinical trial participation are that the newer treatment may have more side effects and may be less effective than the standard treatment. If you are in a control group of the clinical trial, you may not receive the newer form of treatment during your participation. However, you will receive the best care at all times.

Why have I never been approached about a clinical trial?
You have probably not been approached previously if there was not a clinical trial at the time of treatment that was suited for your specific type of breast cancer.

How to decide whether a clinical trial is right for you?
It is essential for you to know the risks and advantages of participation in a clinical trial. Often, it’s a very personal judgment to be made regarding whether or not to enter a clinical trial. Patients are advised to make their decision about trials only during their recovery from diagnosis and surgery.

Many women prefer to be involved in a clinical trial for the following reasons:

  • To avail the best available treatment for their breast cancer
  • Access to new and highly effective treatments No longer responds to current treatment
  • Receive regular and careful medical attention from a research team
  • Access to free medications

Women decide not to enroll in a clinical trial due to the following reasons:

  • Desire to receive the current standard treatment for their breast cancer
  • To retain control of their treatment choice
  • A strong feeling that the risks and side-effects of the treatments under study are not explored to the extent
  • Doctors who deliver care during the trial are different from the treating doctors

You should be assured that refusal to take part in a trial will not compromise your treatment in anyway. You also have the right to leave the trial at any time.

If you are interested in taking part in a clinical trial, ask your doctor about any clinical trials that are appropriate for you.