Clinical trials are often viewed as the best treatment option for a late-stage (Stage III or Stage IV) Breast Cancer patient, so it is important you learn about them as a treatment option to help make an informed treatment decision.
Deciding to participate in a clinical research study is a big step. It’s an important choice for you – and it supports the advancement of medical science and the improvement of healthcare for everyone.
You’ll receive study-related medical care and medication at no cost. It is 100% free; no insurance is needed.
You’ll be monitored by doctors who are experienced in treating Breast Cancer.
You’ll have odds greater than zero, even if you already tried all existing treatments and nothing worked well.
Breast Cancer is when cells in the breast tissue begin to grow abnormally. With Breast Cancer, this usually results in a tumor that can be felt as a lump and seen on an x-ray. If left untreated, the cancerous cells can spread to other parts of the body.
Breast Cancer can easily spread to the lymph nodes, which also indicates a higher chance that the cells have spread to other areas of the body. Due to this, finding cancer in a lymph node can affect the treatment plan. However, not all cancer cells spread to other areas, even if they are in the lymph nodes.
Roughly 41,070 people in the United States are killed by Breast Cancer each year. If detected early, it can be treated, but if not, it can spread to other parts of the body and become more difficult to treat. 255,180 people in the United States were diagnosed with Breast Cancer in 2017. Most of these were women, but a small amount were men, who can also develop cancer in their breast tissue.
If it is is detected early and treated, it is almost always curable, but if it is not, the cancer can advance and spread to other parts of the body, where it becomes hard to treat and can be fatal.
For treatment, Breast Cancer has many options including surgery, chemotherapy, radiation therapy, or a combination of these, which is typically preferred. Different types of breast cancer can react differently to various treatment options, and your doctor will help decide the best course of treatment.
The Studies are evaluating an investigational medication of Breast Cancer. These studies will help determine if the investigational medication is safe and effective at curing or slowing the progression of late stage Breast Cancer and when established therapy provided no clinical benefit for patients’ malignancy.
A clinical trial is carefully designed to closely monitor patients’ progress as they go through treatment with an investigational drug, product, device or method of treatment that has not been approved by the FDA. Clinical research studies help find new ways to treat, prevent and diagnose diseases. Today, all medications prescribed by a doctor must first be tested in clinical research studies. Study participants receive close medical supervision and provide valuable feedback on their experiences.
All clinical research studies in the United States are reviewed by the FDA and other governing bodies called Institutional Review Boards, whose job is to make sure participants’ rights are fully protected and that participants are not exposed to any unnecessary risks.
Participating in a clinical trial is voluntary. Participants may choose to discontinue participation at any time. Before you enroll in a trial, a doctor or nurse will clearly explain the study procedures and requirements. This is called informed consent. Doctors are not allowed to enroll patients in clinical trials without first ensuring they understand what their involvement in the trial means. Once you enroll, you may end your participation at any time.
When participating in a clinical trial, participants receive study-related medications and medical monitoring at no cost. Most studies reimburse for travel and logistical considerations. It is important to find out the insurance requirements of any study you want to participate in.
There are a number of reasons you or your doctor may want to consider participation in a clinical trial, including:
No. The participant will receive all study-related care, including the investigational medication, at no cost. Insurance is not needed to participate in the study and the participant’s insurance company will not be notified.
Reimbursement for travel expenses may be provided. If pre-qualified, the study team will provide more information.
No. The participant’s doctor does not have to give his or her permission to take part in the study. However, either the participant or the study doctor, with the participant’s permission, may contact the personal doctor to discuss the participant’s participation and progress throughout the study.
An investigational medication is a medication that has not been approved by the appropriate regulatory or health authorities, such as the U.S. Food and Drug Administration (FDA), for prescription use. Investigational medications are yet to be proven safe and effective.
Studies will only use placebos when absolutely necessary. In 99% of cancer clinical trials, if a placebo is used, it is given with standard treatment. You will receive either the best known Breast Cancer treatment or a new and possibly more effective treatment. Many trials even combine the standard therapy with a new treatment.
All procedures that address a life-threatening illness pose some risk. Your physician and Breast Cancer treatment team might help you decide if a clinical trial is the best treatment option for you. In late stages of Breast Cancer diagnosis, clinical trials are often viewed as the best treatment option. Keep in mind that all known medications have once gone through the clinical trials process - even aspirin.
Yes, participation is voluntary. The participant may decide to stop or suspend participating at any time. Any participant who decides to stop early should give prior notice to the study team. The study team will ask the participant to return to the study office at least once for a follow-up test to check the participant’s health once the investigational medication has been stopped.
To help ensure the research study is ethical and that participants’ rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review and approve study protocols.
The study team respects and protects every participant’s privacy. The study team will not share the participant’s information except when they are required by law. The study team will store the participant’s personal information with codes that do not identify the participant. The Informed Consent Form has more information about the participant’s privacy and you will need to sign it prior being accepted into the study.
