Treatment and Clinical Trials

Vera Pereskokova was getting dressed in her hotel room while on a business trip in March 2012 when she felt a lump on her right breast. She called her doctor right away to schedule an appointment and was assured it was likely nothing to worry about, so she wasn’t overly concerned when she went in for her mammogram and ultrasound. It came as quite a shock then when the doctor performing Vera’s ultrasound told her that she was fairly certain the lump was malignant. Vera was only 28 at the time.

A week later she was officially diagnosed with Stage II Invasive Ductal Carcinoma and widespread Ductal Carcinoma in Situ in the same breast. Vera underwent a double mastectomy, axillary node dissection, 8 rounds of chemotherapy, and was started on a 5-year regimen of Tamoxifen. She was told by her doctors that she had only a 2-3% chance of recurrence and that she would be free to “go live her life” once her treatment was completed.

But in October of 2015, Vera began experiencing upper abdomen pain. When her labs came back showing elevated liver enzymes, her doctor ordered a chest and abdomen CT. Her oncologist confirmed the devastating news- Vera had Stage IV metastatic breast cancer with numerous tumors on her liver.

Currently, Vera does not have any evidence of cancer in her breasts, but it is still referred to as breast cancer due to its origin. There are too many tumors on her liver to do surgery, and radiation is too damaging to the liver. She is receiving the chemotherapy drug, Taxotere, every three weeks and is enrolled in a Phase II clinical trial where she receives an investigational medication called Indoximod. This clinical trial was suggested to her by her medical team at the time of her diagnosis.

Vera calls her enrollment in the clinical trial a “no brainer”. She was a candidate based on her type of breast cancer, HER2-, ER+. She was already going to be getting Taxotere as part of her treatment regimen and thought it made sense to try another therapy that was showing success in early studies.

Vera is followed closely by her research nurse, meets with her oncologist every three weeks when she received chemotherapy, and gets scanned every 6 weeks. The study is a double-blind placebo-controlled study. This means that some of the study participants are getting the trial medication, while others are given a fake treatment, referred to as a placebo or a sugar pill. Vera offers some advice for women with breast cancer regarding treatment decisions. She says, “I always do as much research as I can and listen to my gut as far as treatments go. That's what makes me comfortable, and I think that will differ from patient to patient. It's important to understand where your comfort level lies in making treatment decisions - is it through doing your own research, asking your doctor questions, trusting that your medical team knows best, etc. - and then let it be. You'll drive yourself crazy if you constantly think ‘what if’ and second guess your decisions.”

Treatment and Clinical Trials

There is not a simple “one size fits all” approach for the treatment of Metastatic Breast Cancer. Your medical team will look at several factors to determine what is the best treatment for you. These include things such as your hormone receptor and HER2 receptor status, where the cancer has metastasized, and your previous treatments and response.
Let’s take an overview of some of the treatment options available. You will find that many of the same treatments are used for early stage breast cancer, but will not be as aggressive in Stage IV since treatment will be long term. For a more in-depth look, the National Comprehensive Cancer Network offers some great information on metastatic breast cancer.

Hormone Therapy
If the cancer cells are found to be hormone-receptor positive, this is usually the first line of treatment. Hormone therapy will attempt to block or lower the amount of hormones in the body, in the attempt to slow the growth of new cancer cells.

Chemotherapy
Chemotherapy is used to destroy cancer cells, but can also kill normal cells in the process. Chemotherapy may be used when hormone therapy ceases to be effective or when the cancer cells are hormone-receptor negative.

Targeted Therapy
This may be used for cancer cells that are HER2 positive. Targeted therapy works by blocking the HER2 protein that is plays a role in cell cancer growth. Targeted therapy has fewer side effects than chemotherapy because it has less of an effect on normal cells.

Radiation
Radiation may be an option after chemotherapy is complete. Beams are aimed at the tumor to try and destroy cancerous tissue.

Clinical Trials
Clinical trials are voluntary studies that test new medical treatments on humans. Clinical trials have different phases (0 to IV) each of which address specific questions regarding whether a particular treatment is safe, if it works and how effective it is compared to the current treatment being used. Often you may learn about different clinical trials from your 
doctor, but you can also search for clinical trials yourself. 


Some good places to start are:

·        Breastcancertrials.org
·        Clinicaltrials.gov
·        Cancertrialshelp.org
·        Sarahcannon.com
·        MBCN.org

Breast cancer patients can benefit from being a part of a clinical trial by receiving access to some of the most cutting-edge therapies, as well as close monitoring by medical professionals during the trial. Many patients also feel a sense of pride knowing that they are contributing to the future of cancer research and treatment.
As with any medical treatment, there are also risks involved with being part of a clinical trial. There are more unknowns with any investigational treatment, so it is important to discuss these risks with your doctor.

Participation in a clinical trial will often mean more doctor's appointments and testing, sometimes requiring you to travel. If you have insurance, make sure to find out what costs will be covered. Study sponsors will also often help pay for the treatment and procedures and may even cover extras like travel expenses, so look into what is available to you.
You are likely to experience many emotions when participating in a clinical trial. From fear of the unknown to excitement about receiving a potentially helpful treatment, try to take all of this into consideration. Know that the decision is ultimately yours.

Alternative Treatments

You may also want to consider alternative therapies. While these are not seen as standard medical treatment, things such as acupuncture, meditation and art therapy may ease your side effects and lower your stress levels, making it easier to get through 
each day.

Whatever treatment decisions are made, it is critically important that you feel comfortable talking with your medical team. Since your medical management will be ongoing, you need to be able to communicate any concerns, questions or troublesome side effects. The goal of treatment is to provide you with the best quality of life while managing the disease, and your input will ensure that happens.