TKI1258, BKM120, trial studies for metastatic breast cancer

There are two studies currently looking for participants. If you are a woman with metastatic breast cancer, and your oncologist hasn’t mentioned the studies to you, bring it up with them. I know the studies are being done nationwide right now (fall 2013). I was expected to begin pre-trial base-line markers this month, but I am not in the studies, after all. More in next blog about that, but I wanted to get this information out to those interested.

One study, TKI1258 (TKI) is a multi-center, randomized, double-blind, placebo controlled, phase II trial. It’s being evaluated for the safety and efficacy of TKI in combination with fulvestrant – also known as Faslodex (a shot). The trial will be of post-menopausal women with Her2, and HR+ breast cancer that have evidence of disease progression on or after [one] prior endocrine therapy.

The other trial study, BKM120, is a phase III randomized, double-blind placebo controlled study with BKM120 with fulvestrant. The participants will be post-menopausal women with hormone receptor positive or Her2-negative, locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment.

There is expected to be 150 TKI and 1,060 BKM participants in the multi-center studies in the USA. Both studies are by the pharmaceutical company Novartis. The hospital where I go was looking for five patients for each study. If you’re interested in the study, look into it. It may take them a while to find matches.

Talk with your oncologist. Good luck!


Why volunteer for a clinical trial?

clinical trialimage credit: Good Search

For many cancer patients, taking part in a clinical trial is a way to contribute to cancer research, and receive some hope for their own improved treatment of cancer. Despite advances made, there is no cure for cancer. Not yet, anyway.

Many clinical trials aim to increase longevity of the patient, while others focus on the patient’s quality of life, lessening side effects of cancer or its treatment. Some trials can offer state of the art, cutting edge care that if successful, won’t be available for several years down the road.

A clinical trial is a structured research study with human volunteers. These volunteers take and evaluate a new drug or treatment before that drug or treatment can be offered to the general public. According to the National Institute of Health, more than 56,000 clinical trials are currently underway in the U.S., and 13,000 trials are recruiting volunteers.

After approval from the U.S. Food and Drug Administration, there are three steps to clinical trials:

  1. Volunteers test the drug, treatment or product safety.
  2. Volunteers test the drug, treatment or product efficiency.
  3. Volunteers test the drug, treatment or product effectiveness. This is the most complicated of all the steps in a trial. This is the stage where dosages, populations, and standard of care are compared.

If the drug is approved and marketed by the FDA (Food and Drug Administration), a fourth stage may occur to test long-term use of the drug, treatment or product.

 Why volunteer for a clinical trial?

When treatment for your cancer or other disease isn’t promising, or when treatment for a rare disease isn’t known, or if you want to contribute to research.

Where to find possible clinical trials searching for volunteers:

National Institute of Health

Leukemia & Lymphoma Society

Many hospital or clinic websites also list clinical trials. Or ask your oncologist. (But keep in mind they or may not know of clinical trials outside their hospital.)

Not all drugs, treatments or products tested are approved by the FDA, and not all patients in the clinical trial receive the new drug, treatment or product. But even the volunteers receiving standard care (as opposed to testing) are monitored, perhaps even rigorously, to compare with the clinical trial.


Clinical Studies

 image credit: Google

Before a drug is approved by the Food and Drug Administration (FDA), it must progress through three stages of clinical trial studies to prove the drug’s safety and effectiveness.

Phase One: The drug is tested on humans for effectiveness and to ensure there are no serious side effects. During Phase One testing, the drug is also tested on other ailments, and in other dosages. If side effects are limited, the testing moves on the next phase.

Phase Two: During Phase Two, the drug being researched is tested on one specific disease in a larger group of patients than used in phase one testing. Pre-determined doses are used, with the focus on how well the drug treats and how well it’s tolerated by the patients.

Phase Three: Phase Three is where “blind tests” are often preformed. This is where the patient isn’t informed which treatment they’re given. During this process, the drug being tested is compared with the existing drug(s). The new drug is again studied for it’s effectiveness, how well it’s tolerated, and it’s safety. The question in mind is, how, if at all, is it better than existing drugs? If the drug makes it to the end of this phase, results are submitted to the FDA for evaluation and approval. This phase can take years, because it involves many  patients and results can often be subtle, or working in favor of some, but not all patients.

When a drug enters Phase One clinical trials, analysts figure it has a 10%-20% chance of becoming marketable. As each phase is successfully completed, analysts may increase their estimation of the new treatment’s marketability. Investors are interested in bidding on the odds of hope—cancer research, specifically biotechnology. According to Kiplinger’s Personal Finance Magazine, 12/2012 biotech’s disappointing history for stockholders is a thing of the past. With new cancer-drug development being tested, biotech could be the win we’re all waiting for. If you’re interested in company specifics, there are seven biotechnology companies and their progress is in the 12/2012 issue of Kiplinger’s Personal Report. Your library may have a copy.

Clinical Trials

 image credit: Google

If you’re interested in taking part in clinical trials, you may need to be the one who speaks up first. Don’t wait for an invitation, let your interest and desires be known. Just because your doctor doesn’t mention or know of a study, doesn’t mean it’s not out there. The Journal of Oncology Practice published a 2011 survey: 44% of 213 trial-eligible cancer patients didn’t recall discussing trials with their doctor. There may, or may not be a clinical trial going, and it may or may not be the right fit for you.You won’t know until you ask.

It’s not just a matter of finding a trial, you need to know what that entails for you. According to The National Cancer Institute and The American Cancer Society, here are some questions you may want to ask before you jump into risks and benefits of a trial. They are taken from the website below:

Why does the research team think the experimental treatment will work?

Who has reviewed and approved the trial?

Who is sponsoring and funding the trial?

Will some of the trial participants receive a placebo rather than active treatment?

What are the treatments, scans and other procedures participants can expect to undergo? Which ones are experimental  (specific to the trial) and which are normal care?

What are the short-term and long-term benefits and risks to the treatment?

Who will supervise the participant’s therapy?

What expenses, if any, will the insurance provider or the participant have to pay?

Where is the study site, and how often will participants have to visit it?

How long will the study last?

How will the study affect the participant’s daily life?

There should be a phone number listed with the clinical trial summary. Call and ask to speak to the research team directly. They’ll able to tell you if you meet the study criteria.

For the related article to the above questions: CureToday