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standard treatment vs clinical trial

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atlhoosier View Drop Down
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    Posted: Feb 18 2014 at 11:40pm
Hi everyone.  I was recently diagnosed and I am having a hard time deciding between the standard treatment and the clinical trial.  I will be going through chemo first and then surgery.  My oncologist presented the standard treatment plan of 12 weeks of Taxol, 4 cycles of carboplatin, followed by 4 cycles of AC.   The clinical trial is sorafenib pill taken daily for 24 weeks, with 4 cycles of cisplatin & 4 cycles of taxol.  I feel like the possibility of having future heart problems or cancer returning due to taking AC is crippling my decision.  But the possible side effects from the clinical trial also frighten me--they include liver & pancreas damage, lung collapse, or kidney damage/failure.  I am supposed to start chemo next week on the 28th.  I am currently going through fertility treatments to freeze embryos and will finish this week.

I see that most people have gone the route of the standard TAC treatment which is somewhat calming to me.  I know the addition of carboplatin is very new for TN.  I have also seen some women say that they did the clinical trial and feel that it saved their life.  I am wondering did most of you only have the standard option or was there a clinical trial available that you chose not to participate in?  If you chose the clinical trial, how did you come to that decision?  If you were in the same position as myself and chose the standard treatment, what swayed your decision?

I know that no one except for myself can make this decision, but I do appreciate any advice/comments.  I have a few other general questions pertaining to other posts and hope someone can answer them.  They are:

Why is testing for vitamin D deficiency important?
Some people have mentioned taking aspirin daily--why?
What is a Ki # and why is that important or what does it relate to?

Thank you!


DX Jan 2014, 37yo
TNBC, Stage 2A, 4 tumors, BMX Aug 2014, clear margins

2017 - Mets to lung (single nodule) & sacrum
1st line(current): clinical study w/ taxol & reparixin (may be placebo)
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Kellyless View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Kellyless Quote  Post ReplyReply Direct Link To This Post Posted: Feb 18 2014 at 11:55pm
can you point us to the information on the trial you're being offered? I've only seen trials with those meds for advanced stage Mets cases, not someone like you - young at 37, with no signs of spread even to nodes? Perhaps we can ask Steve about this, he may know something. 
IDC, 2.2 cm, Stage IIb,lumpectomy 1/30/09 ACx4,Tx4 36 rads
6/1/17 Local recurrence same breast, same spot 1.8cm Carb.4x every 3 wks, Taxol 12x once wk. Dbl Mast. PCR!! Reconstruction fail, NED!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Duchess13 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 19 2014 at 12:02am
Clinical trials are not always for advanced stage mets.  I participated in one and to qualify you had to be stage II or stage III.  As stated above, it probably saved my life.  My oncologist stated that anyone with TNBC should try and get into a clinical trial if possible.
 
Christina
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atlhoosier View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote atlhoosier Quote  Post ReplyReply Direct Link To This Post Posted: Feb 19 2014 at 12:28am
Here is some info:

http://clinicaltrials.gov/show/NCT01194869


DX Jan 2014, 37yo
TNBC, Stage 2A, 4 tumors, BMX Aug 2014, clear margins

2017 - Mets to lung (single nodule) & sacrum
1st line(current): clinical study w/ taxol & reparixin (may be placebo)
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atlhoosier View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote atlhoosier Quote  Post ReplyReply Direct Link To This Post Posted: Feb 19 2014 at 12:28am
Christina, what was his reason for saying that?
DX Jan 2014, 37yo
TNBC, Stage 2A, 4 tumors, BMX Aug 2014, clear margins

2017 - Mets to lung (single nodule) & sacrum
1st line(current): clinical study w/ taxol & reparixin (may be placebo)
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atlhoosier View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote atlhoosier Quote  Post ReplyReply Direct Link To This Post Posted: Feb 19 2014 at 12:33am
Kellyless, to my knowledge it has not spread to my lymph nodes, however I need to follow-up with the oncologist, because the surgeon actually made a comment about my pet-ct scan that was a little confusing.  The pet-ct scan only showed the cancer in my left breast and nowhere else, thankfully!  But when the surgeon called me he said it showed in the nodes in the left breast.  I am not sure if he was referring to the tumors that are present or if it is truly in the lymph nodes. 
DX Jan 2014, 37yo
TNBC, Stage 2A, 4 tumors, BMX Aug 2014, clear margins

2017 - Mets to lung (single nodule) & sacrum
1st line(current): clinical study w/ taxol & reparixin (may be placebo)
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 19 2014 at 9:07am
atlhoosier,

To answer a few of your questions:

1.  It's important to know you Vitamin D levels.  Most of us diagnosed with bc are deficient.  It is believed that having normal levels help you recover better from surgery and makes chemo and radiation more effective.  Check out the Vitamin D3 thread on the forum:
http://forum.tnbcfoundation.org/vitamin-d3_topic5338_page36.html

2.  Studies have shown taking a low dose aspirin may help prevent bc or a recurrence.  Please check with your oncologist before taking an aspirin during treatment.  


3.  KI67 is a measure of how fast the cancer cells are growing.   Most of us with TNBC have a higher KI67.


4.  Regarding your choice of chemotherapy.  It's a difficult decision.  Can you get a second opinion?  I don't know much about sorafenib except that it's being used in a clinical trial.  

At the latest SABCS, there was encouraging data about adding Carboplatin to the chemotherapy regime.  Please check out this link:


Donna
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote mainsailset Quote  Post ReplyReply Direct Link To This Post Posted: Feb 19 2014 at 9:43am
I was on a clinical trial and my first thought is that there are now many clinical trials recruiting now for Tneg. I say that because your doctor may actually have more trials available and/or you might go to a 2nd doctor for an opinion that has a different set of trials available to him...

Ask your doctor for the clinical trial id #, then go to the clinical trial website and look it up. If the trial is a I, that means it is newer in the process and what I'd feel more comfortable with is a trial II or even a III. Then look at how long your trial has been ongoing and recruiting. If, for instance it is a II that has only been recruiting for a couple of months, you won't be getting as much assurance of success as say a III that's been ongoing for a year or more. A trial that exposes unacceptable side effects is discontinued so a trial that is a year old or more has been able to manage side effects.

Trials are research. It's important to match the trial's drugs to your type/subtype of Tneg. I found that the trial I was on involved more scans and blood tests (which was ok with me) than the standard protocols. The research pharma wants to be successful to take the drug to market so they monitor like crazy.

All in all, I'd ask your onc if there are other trials he can make available to you and why he chose that trial and not another. Then I'd go get a 2nd opinion from another clinic and let them educate me as to what they think are my options. The important thing is to remember that you don't want just 'an aggressive treatment' you want the 'right' aggressive treatment.

Google "Sorafenib side effects problems' and spend some time doing a Google search.

Lastly, did I mention that it's a good thing to look over your clinical trial contract before you sign, see if you can get a copy. The contract will give you great insight into what you're getting into. The big thing is to figure out what the known side effects are and see if you are comfortable with them and what the doctors can give you to offset; ie heartburn/Zantac, BP rise, neuopathy etc

Best of luck to you, I know I was pretty lost when it came to choosing but I'm happy I went with the trial.
dx 7/08 TN 14x6.5x5.5 cm tumor

3 Lymph nodes involved, Taxol/Sunitab+AC, 5/09 dbl masectomy, path 2mm tumor removed, lymphs all clear, RAD 32 finished 9/11/09. 9/28 CT clear 10/18/10 CT clear
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Duchess13 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 19 2014 at 3:51pm
Hi Atlhoosier,
 
Let me first start with that the oncologist that I have now was not my first oncologist.  I was first
diagnosed in the small town where I live.  I had my biopsy and was sent to a general surgeon for the complete results.  When I went to see  him, he did not have all the information,  just the mammogram films and incomplete biopsy results (no receptor information).  He could not tell me  the receptor information and estimated that I was probably stage IIb.  I knew immediately that I was not going to
stay locally for treatment and that I would be going to Houston, Texas for my breast cancer.  The medical center is 2 and half hours away.  Next question was where?  I had friends recommend MD Anderson, Baylor and Methodist.  My gut feeling was to go with Methodist.  A friend who's mother had gone there gave me the name of an oncologist and surgeon.  I contacted the oncologist and made an appoinment.  During the week while I was waiting to see him, I was reading up on what Methodist offered for breast cancer.  One of the things I read was about a clinical trial for TNBC.  It really did not mean much to me at the time, but I remembered it.  When I made the appointment with the oncologist, he had me send him all my medical records and scheduled a PET scan for me the day of my appointment with him.  After the PET scan, I met with him and that's when I got the bombshell dropped on me.  I was stage IIIb and I had TNBC.  The first thing out of my mouth was asking a question about the clinical trial that I had read about.  He then went over with me the the traditional option (6 dense doses of ACT), then a mastecomy and then radiation and then got the information on the trial and called the doctor who was heading the trial to see if I could come talk with him.  He gave me plenty of information on both options and recommended that I speak with the other oncologist and decide what option I wanted.  He told me that either option was a good choice.  The next day he called me and said that I had an appointment to meet with the clinical trial doctor.  I then went on to research all the drugs involved and write all the questions to ask at the appoinment.  I met the trial oncologist, and was very impressed.  He took the time to answer all of my questions and went on to tell me that one of the drugs used in the trial (cistplatin) had a good reputation for survival with TNBC.  He also went on to tell me that if his wife, mother or sister were diagnosed with TNBC, he would recommend a clinical trial as new and improved drugs are being used in them.  To make a very long story short, I continued to see both oncologists throughout the trial (if you choose the trial, you will be monitored closely) but in the end when it was time to leave the clinical trial oncologist and go back to my original oncologist, I chose to stay with the clinical trial oncologist as he was a research oncologist, he only treated breast cancer and he specialized in TNBC.  I feel very blessed to have him as my oncologist.  He is one of the most compansionate physicians I have ever met and probably saved my life.  Choosing the trial was right for me and I do not regret it.
 
Christina
 
 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote atlhoosier Quote  Post ReplyReply Direct Link To This Post Posted: Feb 22 2014 at 8:52am
Hi Christina,

How long ago did you go through your treatment? Did you have multiple tumors?

Also, I did confirm that it has not spread to the lymph nodes, at least not that is obvious.

Thank you,
Audrie
DX Jan 2014, 37yo
TNBC, Stage 2A, 4 tumors, BMX Aug 2014, clear margins

2017 - Mets to lung (single nodule) & sacrum
1st line(current): clinical study w/ taxol & reparixin (may be placebo)
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Lillie Quote  Post ReplyReply Direct Link To This Post Posted: Feb 22 2014 at 5:56pm
Hello atlhoosier,
 
Good luck with finding the very best treatment regimen for you.
 
My oncologist recommended a trial for me.  It was dose dense A/C plus dose dense Taxol with gemzar added as the trial drug.    I had a 1 in 3 chance of getting into the gemzar arm.  I was randomized into the trial with the gemzar and that is what I did.  My oncologist told me if I had gotten randomized into another arm of the trial he would not have let me participate in that particular trial.   He really had my best interest at heart.  The problem you have to watch out for is getting randomized into a weak arm of a trial.  If that happens you will get monitored a lot, but you will not be getting the best treatment regimen.  Any competent oncologist will not let you participate in a trial if it is not in your best interest.
 
I hope you could follow my rambling but my sister-iin-law got randomized into the arm of a trial which only had TC plus radiation.  She was stage IIIc with many cancerous nodes.  Her Incompetent oncologist let her proceed with the TC plus radiation and needless to say, it didn't work.
 
Good luck with everything.
 
God Bless,
Lillie
Dx 6/06 age 65,IDC-TNBC
Stage IIb,Gr3,2cm,BRCA-
6/06 L/Mast/w/SNB,1of3 Nodes+
6/06 Axl. 9 nodes-
8/8 thru 11/15 Chemo (Clin-Trial) DD A/Cx4 -- DD taxol+gemzar x4
No Rads.
No RECON - 11/2015-9 yrs NED
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Duchess13 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 22 2014 at 9:26pm
Lillie is right.  Make sure it's a strong clinical trial with all components there.  With my trial, if I would have gotten the placebo and not Everolimus(the research drug), I still would have gotten Cistplatin and Taxol for 12 infusions, then surgery, then the 4 rounds of AC every two weeks and the radiation.  With or without the research drug, all the major players were still there to fight my cancer in addition to the Cistplatin.  My oncologist discussed this with me and answered every question I asked him.  Never once did I feel pressured to choose the clinical trial by either oncologist.  It was an initial gut feeling to go with the clinical trial and after the research I did on the all the drugs it was good choice for me.  I weighed all my options and felt fortunate that I had options with my treatment and was able to make a choice.
 
Wishing you all the best !!
 
Christina
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Duchess13 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 22 2014 at 9:30pm
Almost forgot, I started my treatment in September of 2011.  I had one large tumor 4cm and one smaller tumor plus several lymph nodes involved.  I was stage IIIb.  I'm just about at 2 1/2 years from diagnosis and 21 months NED.  Sorry about that.
 
Christina
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Post Options Post Options   Thanks (0) Thanks(0)   Quote ShannonD Quote  Post ReplyReply Direct Link To This Post Posted: Feb 26 2014 at 10:08pm
I was dx in 2010. Had chemo, surgery, radiation and then chemo. I was in the PHARP trail for 9 months. After 9 months of NED I had mets to lung. Was then tx with abraxtin and avaistin for the next 1 1/2 year. That chemo shrunk the tumor, but beat up my body. Because the tumors were not growing or shrinking my doc took me off abraxtin. 4 months later mets to liver. My onc wanted me to participate in a study. He stated studies gives me more options, the more options the better my changes of survival. I am currently in the ENMD-2076, Aurora and Angiogeniq Kinase Inhibitor study for tn women. It is a phase II and has been in research for the past 2 years. 

The good news is that by doing this study it leaves open other chemo options for later if needed. If this works then I will stay on it. I take 5 pills a day for 15 days and have very little side affects. I just started 5 days ago, but because my body is very receptive to meds I am prayerfull.

Bottom line trails give you options and can help others.

Shannon
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Post Options Post Options   Thanks (0) Thanks(0)   Quote nancykind Quote  Post ReplyReply Direct Link To This Post Posted: Feb 28 2014 at 10:15pm
atlhoosier, what phase is the clinical trial in?
Lg lump never visible on any films but found 9mm. Lump 1/25/12, DX 1/31@50yrs IIIC/TN/DCIS/INV, Margins Unclr, Ki67 40%,Gr2. MX L 2/24. 3.1cm total. 11/17nodes. AC/T 2xWk,33rads. 12/12 MX R. 9/13 NED!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 28 2014 at 10:59pm
The clinical trial is a phase 2.

Preoperative Clinical Trial of Sorafenib in Combination With Cisplatin Followed by Paclitaxel for Triple Negative (ER-, PR-, Her2-)Early Stage Breast Cancer

DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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