what are the most promising clinical trials???

Hello. New to this site.

My wife was recently diagnosed with a high grade stage 2 triple negative invasive ductal carcinoma.  No nodal involvement but 2.3 cms.  She is 28 yrs old and 20 weeks pregnant.  No family history of CA whatsoever.  The pregnancy makes it impossible to get the proper imaging to stage this certainly (CT, MRI with contrast, bone scan, & PET scan are bad for baby).  Fortunately, the pregnancy hormones, according to our oncologist, are not accelerating tumor growth due to its being hormone receptor negative.  She has just had a port placement with sentinal node biopsy and her first chemo treatment--A-C.  (for those wondering, these chemo drugs don't cross the placental blood barrier, or at least don't cross enough to be very dangerous to the fetus).  Her pregnancy also makes her ineligible for a clinical trial at this time.  I am using this time, however, to research the best clinical trial to become involved with.  This diagnosis is still very new and scary for me but I am trying to use every resource available to battle this cancer from every angle. 

 

Despite being in the medical field, I don't know much about clinical trials.  What is the ratio of test subjects to control (placebo) group? Is it 1:1?  Is there any evidence that looks promising for any drugs/chemos/vaccines specifically targeted towards triple negative breast cancer? 

I'm guessing that you can only be involved with one clinical trial.  Is this true?  Do you get to pick which one you want to be involved with or do you just sign a paper and the oncologist picks for you?

Most of all I would like to see any in vivo and/or in vitro evidence of success with treatments targeted towards triple negative breast cancer.

 

Thanks and God bless,

Will

 

 

Edited by will - Jan 17 2009 at 11:43pm

Will--Although it has been several years since I've been in graduate school I will address your questions about clinical trials and hope that my information is helpful. 

Most trials involving cancer do not have a placebo group as it would be unethical to treat any cancer-containing arm with placebo, or basically nothing.  Instead of placebo, the control group in a cancer trial will usually receive a 'standard' treatment involving some accepted antineoplastic drug while the other arm or arms will receive that drug plus the trial drug, often at various doses.  Because there may be several treatment arms receiving various doses of the trial drug, the ratio of control to treatment groups may be less than 1:1.  In cases where there is one control and one treatment group, however, the investigators strive for a 1:1 ratio but that is seldom exactly obtained.  Regardless of which ratio of control-to-treatment the trial began, however, attrition tends to change it as the trial progresses. 

As to the number of trials one can be involved in, for any involving treatment a patient would be limited to one.  When eligible for more than one trial, a patient should be able to choose which she wishes to participate in. 

There are still no treatments targeted only to TNBC but nevertheless there are treatments to which TNs respond quite well.  These include, under DNA-damaging chemotherapy, the platinum drugs (carboplatin (Paraplatin) and cisplatin (Platinol)), cyclophosphamide (Cytoxan), the anthracyclines doxorubicin (Adriamycin) and epirubicin (Ellence), and the antimicrotubular taxanes paclitaxel (Taxol) and docetaxel (Taxotere).  Most of these drugs are used extensively in this country in first-line chemotherapy against TNBC with good success; however, please keep in mind that individual exceptions can and do occur.  For that reason it is a good idea if possible, and from your post it sounds as though this is is the case, that neoadjuvant (before surgery) chemotherapy is performed so that the tumor's response to the chemotherapeutic agent can be ascertained.  Once the tumor is removed, the response of it (and of any invisible distributed tumor cells remaining) cannot be known nearly as well; there is a specialized blood test to track remaining tumor cells but its availability is small and at this point most centers that have it prefer to constrain its use to the metastatic setting. 

For more information about TNBC and some good myth-busting facts that can be very heartening I would like to point you to this site, where the editor has not only done extensive reading on this complex and frightening disease but also taken the time to synthesize the information into more-easily-digestible subcategories:  http://bcwatchdigest-triple.evidencewatch.com/

--jackie


Edited by ziggy0 - Jan 18 2009 at 9:04am