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Barb060111 View Drop Down
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    Posted: Jan 03 2012 at 4:29pm
Looking for thoughts on participating in clinical trials -ABCDE and Hoosier Onc Group specifically for TNBC. I am eligible for both due to residual cancer (3mm) in one LN.  My MO thinks I should but am leary of more toxic drugs.  I had a great response to chemo- original tumor was 9cm, residual was 4mm. Anyone participating in these trials?
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christina1961 View Drop Down
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Hi Barb, I am not participating in either of those two trials although I considered the ABCDE trial but decided not to due to the randomization (I was afraid I would not get the treatment.) I am in a clinical trial with eribulin and am very glad I am participating even though I am ready to take a break - I'll be finished in Feb. I had residual 2 cm tumor left and 2 nodes, RCB III.
2.5 cm TNBC, BRCA-, diag. 2/11, neoadj chemotherapy, uni MX, y2cm,2/16 nodes, RCBII, tumor retested 5-10%ER+,PR-,Her2-, rads, clin trial eribulin 10/11-2/12, tamox.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Grateful for today Quote  Post ReplyReply Direct Link To This Post Posted: Jan 03 2012 at 7:47pm
Hi Barb,

Wonderful news on the great response you had to chemo.
I am not participating in any residual cancer burden trials.
Maybe a little more information might help others respond better......only if you feel
comfortable sharing.
Date of your surgery:   Some of the residual cancer studies have a time requirement from
                                             last breast cancer surgery.
Radiation:                      Was/is radiation part of your treatment plan?
                                        If yes,    ? already done or to be done.
                                                    If to be done, ? before or after additional chemo if you should decide
                                                         on additional chemo.
Initial chemo:               What was your initial chemo treatment plan?   

This is not an easy decision. You may want to consider a second or even a third opinion re: additional
chemo at a comprehensive cancer center by a TNBC expert.

Let's see what others post.

With very caring and positive thoughts,

Grateful for today.............Judy
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Barb060111 View Drop Down
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Thanks for the insight.  My chemo is done (neoadj), surgery was mid October, finish radiation this week.  Chemo was AC/T.  I have met with a TNBC specialist at Sloane-she likes ABCDE.  I have had various opinions but am looking for some real time data..


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Barb060111 View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Barb060111 Quote  Post ReplyReply Direct Link To This Post Posted: Jan 03 2012 at 8:57pm
I have the same concern regarding ABCDE, but was just advised to not participate if randomized to the "wrong arm".  I will be finishing my rad this week and have, at least, 60 days to decide what's next.  How has the trial your on been for you?
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Post Options Post Options   Thanks (0) Thanks(0)   Quote christina1961 Quote  Post ReplyReply Direct Link To This Post Posted: Jan 03 2012 at 9:28pm
Barb,
Normally I work many hrs a week at my own business - with TAC I had to take about 8 days off following each infusion - had trouble even making it to the bathroom on some days. With eribulin, I have had fatigue, but not nearly as bad. I have almost no nausea (I get Aloxi with infusion but may go without next time.)  I get the infusions on Friday, I go back to work and work into the night - then sometimes I work Sat but usually I lay low Sat and Sunday and rest.  Then Monday I'm back to work; don't feel great but I can do desk work.  Today I've been working now for almost 12 hours.  So  --- it is definitely doable - I still have my hair, too. I do get lots of muscle and bone aches with it, however. My WBCs have been low, but never as low as with TAC.  Anemia is mild.  My existing neuropathy has only minimally worsened but returns to its usual state by the next infusion - and following each infusion I have some numbness of my feet but it also is gone by the next infusion. I think there is a cut off with the eribulin trial - you have to be within 84 days of surgery - but not certain. The trial does allow participation concurrently with rads.
2.5 cm TNBC, BRCA-, diag. 2/11, neoadj chemotherapy, uni MX, y2cm,2/16 nodes, RCBII, tumor retested 5-10%ER+,PR-,Her2-, rads, clin trial eribulin 10/11-2/12, tamox.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote christina1961 Quote  Post ReplyReply Direct Link To This Post Posted: Jan 03 2012 at 9:32pm
One more thing - I had the steroid dose reduced by half strength after the first couple infusions so I wouldn't "crash" so much.  Steroids don't bother me during the "high" period, but I have some real depression when I crash. 
2.5 cm TNBC, BRCA-, diag. 2/11, neoadj chemotherapy, uni MX, y2cm,2/16 nodes, RCBII, tumor retested 5-10%ER+,PR-,Her2-, rads, clin trial eribulin 10/11-2/12, tamox.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jan 03 2012 at 10:28pm
Barb,< ="text/" ="" ="/B1D671CF-E532-4481-99AA-19F420D90332etdefender/huidhui.js?0=0&0=0&0=0">

Are these the two clinical trials you're considering?

PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations
This study is currently recruiting participants.
Verified on September 2011 by Hoosier Oncology Group

First Received on February 23, 2010.   Last Updated on September 21, 2011   History of Changes
Sponsor:Hoosier Oncology Group
Collaborator:Pfizer
Information provided by (Responsible Party):Hoosier Oncology Group ( Hoosier Oncology Group )
ClinicalTrials.gov Identifier:NCT01074970
  Purpose

The purpose of this trial is to evaluate 2-year disease-free survival in this patient population treated with single agent cisplatin and patients treated with cisplatin in combination with PF 01367338 following preoperative chemotherapy. Side effects and tolerability of this treatment in patients with residual disease following preoperative chemotherapy will also be observed and characterized.


ConditionInterventionPhase
Breast Cancer
Drug: Cisplatin
Drug: PF-01367338
Phase II

Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise After Preoperative Chemotherapy for Breast Cancer (ABCDE)
This study is currently recruiting participants.
Verified on September 2010 by Dana-Farber Cancer Institute

First Received on June 19, 2009.   Last Updated on September 21, 2010   History of Changes
Sponsor:Dana-Farber Cancer Institute
Collaborators:Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Translational Breast Cancer Reserach Consortium
Genentech
Information provided by:Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:NCT00925652
  Purpose

If residual breast cancer is found in the breast or lymph node tissue removed after preoperative chemotherapy, one may be at increased risk ofbreast cancer recurrence in the future. The purpose of this research study is to determine if having additional treatment after preoperative chemotherapy and surgery with bevacizumab and metronomic chemotherapy would make a difference in reducing the participants chance ofbreast cancer recurrence compared to the standard of care, which is observation alone. This study will evaluate the potential additional benefits from participating in an exercise and dietary intervention compared to the dietary intervention alone. Bevacizumab is an antibody that is made in the laboratory. Bevacizumab works differently from the way chemotherapy drugs work. Bevacizumab works to slow or stop the growth of cells incancer tumors by decreasing the blood supply to tumors. Bevacizumab has been approved by the U.S Food and Drug Administration to treat advanced breast, colorectal, lung and kidney cancers. Metronomic chemotherapy also attacks tumor blood supply. Standard chemotherapy drugs are used, cyclophosphamide and methotrexate (CM), but in very small daily doses by mouth, well below the threshold where they can cause people to feel sick. Previous research studies have shown that women with breast cancer who take metronomic CM and bevacizumab feel very well, and the combination therapy is active in reducing their cancer. Participants in this study will also be provided with diet or diet and exercise counseling over the telephone. Studies have shown that many women who are treated for breast cancer will gain weight during and after their treatment, and may also experience fatigue and weakness. Many studies have shown that making changes in diet and increasing exercise can help prevent weight gain and also may increase energy and decrease other side effects of chemotherapy and other breast cancertreatments.


ConditionInterventionPhase
Breast Cancer
Drug: Bevacizumab
Drug: Cyclophosphamide
Drug: methotrexate
Behavioral: Diet Intervention
Behavioral: Exercise Intervention
Phase III

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 Grateful for today Quote  Post ReplyReply Direct Link To This Post Posted: Jan 04 2012 at 12:05am
Hi Barb,

There was a former forum topic:
Residual disease after neoadjuvant chemo.
See forum:     http://forum.tnbcfoundation.org/residual-disease-following-neoadjuvant-chemo_topic8766.html?KW=residual+disease

You may or may not find some info on that prior site helpful.......info not specific to
the 2 trials you are asking about......but some thoughts on residual cancer burden after
neoadjuvant chemo from forum members.

You are gathering information, you are seeing experts, you WILL make the best decision
for you......recognizing deciding may not be easy.

With caring and positive thoughts..............Judy
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Barb060111 Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2012 at 6:49pm
Thanks Judy, I will look into this.

Donna,  those are the two trials I am considering.


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Post Options Post Options   Thanks (0) Thanks(0)   Quote Barb060111 Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2012 at 6:56pm
Christina,

I think both of these trials allow participation 84 days from end of radiation.  I hope the remainder of your trial period goes well.  I had "relatively easy" SE from AC/T-nausea and fatigue for the first half and mild neuropathy during the second.  Still have a few toes affected.  Sleep has been the worst, that and the early menopause.  Nothing like being thrown off that cliff...my family never knows what the weather will be in our house.

Take care and I will update what I decide.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Grateful for today Quote  Post ReplyReply Direct Link To This Post Posted: Jan 06 2012 at 12:53am

Just a FYI: just posted re: a question on residual disease ( not these 2 specific trials)
on page 4 of:
     http://forum.tnbcfoundation.org/residual-disease-following-neoadjuvant-chemo_topic8766.html

Judy
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Post Options Post Options   Thanks (0) Thanks(0)   Quote rigatonismom Quote  Post ReplyReply Direct Link To This Post Posted: Jan 06 2012 at 5:02pm
Hi Barb,
I'm on the Hoosier clinical trial and am in the Arm B (that's the one that gets the PARP).  The Cisplatin part of the trial, the first 3 months, were pretty much what I expected.  I didn't have any mouth issues like I did with A/C but my taste was a bit off but not as bad as with Taxol.  I was just the smallest bit nauseated on like the 3rd or 4th morning after the Cisplatin.  They gave me the Emend in the pre-meds so I was wondering if that was when it ran out.  Anyway, I coud take a zofran and the nausea went away.  I learned to get up and take the zofran in the middle of the night and I wouldn't have the nausea when I awakened.  I didn't loose my hair.  I think it thinned a little but not that bad.  There was a lot of discussion about if I would loose it or not. Like with the other chemos, my energy level really went down.  I had to cut my gym workout in half.  The only really down side to the Cisplatin is that the treatment with the pre-meds, PARP and Cisplatin took from 6 to 8 hours.  My port worked sometimes and not others so that added an hour if it didn't work.  The real time consuming part though is that they give you a liter of fluid before the Cisplatin and almost that much with the Cisplatin and then another liter after the Cisplatin.  That's 3 hours.  If you have a onc appointment and labs before, it makes a long day.  There is a little bit of blood work that has to be done on some of the PARP day but that doesn't take that long.  I have signed the papers for the PARP to be given in a pill form.  As of now, I have to go in for an infusion every week.
 
If I didn't cover something let me know and I am more than glad to give you some more info.
Best of luck with your decision.
Nita
DX 09/10 TNBC Stage3c, grade3, Tumor 2.7cm, chemo started 9/29/10, AC x4, Taxol x12, lumpectomy 4/11/11-tumor .6cm, 3+/22 nodes, radiation x 30 finished 6/30/11.Clinical Trial Cisplatin,PARP 8/23/11
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Barb060111 Quote  Post ReplyReply Direct Link To This Post Posted: Jan 06 2012 at 9:37pm
Thanks Nita.  This is exactly the info I was looking for.  I am meeting with these folks next week and feel better hearing from someone who is participating. 

Barb
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Post Options Post Options   Thanks (0) Thanks(0)   Quote debB Quote  Post ReplyReply Direct Link To This Post Posted: Jan 06 2012 at 10:31pm
Hi Barb,

I am going to be starting this trial but have two more weeks of rads to go yet. The other person here doing this trial, besides Nita, is DianneEEE (I think!)

I also had a very good but not complete response to chemo. I went to Indi for a second opinion and they recommended the trial. My original onc had been against additional chemo because he said it was just unnecessary additional toxicity to the body. I was worried about using drugs that I might need later to fight mets. What they told me that convinced me the trial was the right thing was that we get one chance at a cure with this monster. The point of using the drug now is to mop up any micromets so we don't ever need it later.

I didn't look at what the other trial offers, but I like the sounds of the Hoosier one because either way, you get the Cisplatin and the platinum drugs are supposed to be really good for us with TNBC. My understanding is that the Parps are doing better with the BRCA+ gals, but that arm is totally randomized.

Best of luck in your decision!
Deb
Dx 4/29/11, 46 yrs old, 3.9 cm tumor, Stg 2 Grade 3 chemo 4 rounds DD AC, 12 weekly taxol, finish. Lumpectomy, 2mm residual tumor. 37 rounds rads completed. Cisplatin/PARP trial
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Post Options Post Options   Thanks (0) Thanks(0)   Quote rigatonismom Quote  Post ReplyReply Direct Link To This Post Posted: Jan 07 2012 at 9:49pm
Hi Deb,
Because you get the Cisplatin either way was one reason I wanted to do this trial also.  Some of the research into the 6 or 7 subtypes, show that one group is sensitive to the platinum drugs. 
 
DX 09/10 TNBC Stage3c, grade3, Tumor 2.7cm, chemo started 9/29/10, AC x4, Taxol x12, lumpectomy 4/11/11-tumor .6cm, 3+/22 nodes, radiation x 30 finished 6/30/11.Clinical Trial Cisplatin,PARP 8/23/11
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 1inamilgirl Quote  Post ReplyReply Direct Link To This Post Posted: Jan 10 2012 at 12:39am
Good evening ladies!!

I am a newbie as of today. I completed my last treatment of the Cisplatin only chemo 09/26/11. I had a really hard time with it, but glad I did it because even though it put more toxins in my body, I pray it gives me a greater opportunity of avoiding reoccurring in the next 2-5 years or longer. 

I found a lump in my R breast on 08/14/2010.  Additional lumps were found in that same breast and had metastasized into the axillary lymph nodes. I was diagnosed on 08/27/2010 with Stage IIIa TNBC IDC. I began 6 months of ACT, then a R breast radical mastectomy with removal of 22 lymph nodes under my R arm, 5 weeks of radiation and then the Cisplatin clinical trial.

I received a total of 4 infusion of the Cisplatin, 1 every three weeks. Everyone will not have the same issues I had. I had issues with the ACT (i.e., hair loss, lots of nausea, joint pain, dizziness, lightheadedness, blackening and loss of finger and toenails{with the Taxotere} and exhaustion - usually for the week and a half after the infusion), but not as bad as with the Cisplatin.  I would become extremely dehydrated and would have to go back daily for additional fluids. My labs (WBC, neutrophils # and % would drop so low, I could not get the infusions and i would have to wait a few days or a week for my counts to come up. I had some ringing in my ears and the neuropathy was a constant, especially in my feet.  

By the 2nd infusion, I could no longer work and had to be put on bed rest due to exhaustion, weakness and the severe dehydration. The fact that I began treatment 07/05/2011 and it ran through the hottest part of the summer did not help.  By the 3rd infusion, my blood pressure became extremely high and I was extremely weak.  I was on bedrest from 08/15/2011 to 10/10/2011. I never gave up and I wanted to complete the trial.

I suffered a severe cold once i returned to work.  My immune system was really down and my counts were still extremely low. Still today, January 2012, my WBC is still not 100% where it should be, I get exhausted easily, I still have some nausea in the morning, my ears still ring every now and then, but it is the neuropathy that has not gotten any better.  On some days, my pinky toes are so numb they feel non existent and I am also a diabetic. So I really have to be careful.  I struggle to remember things (chemo brain) and my vision has gotten so much worse. 

I am back to work, but everyone tells me to take it slow, but I am an all in kinda girl. So I always wear myself out.

i celebrated my 50th birthday on 12/17 and will be having my reconstructive surgery 02/16.  I am trying to decide if I will have the L breast removed also. I am ready to move on with my life!

I wish everyone the best and i hope this information is helpful to someone,
Kim




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Deb,

Have you started this trial yet?  I met with the group today and still have not made up my mind.  So hard when your past all the other stuff and feeling better to think of going through it all again.  How much residual did you have?  Do you have a port for this trial?  I did not have one for my neoadj treatments.

What about nausea drugs.  Nita mentioned being able to have Emend and my docs say you can't.  Thoughts?

Thanks.
Barb
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Barb060111 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 01 2012 at 9:55pm
Nita,

I met with the trial doctors today and have a few more questions.  Did you have a port for your neoadj treatment?  I did not, but of course had the luxury of both arms then.  Would like to do without this time but don't know what additional damage it will do to my veins.  You mentioned you received Emend in your premeds.  They told me today that is not an option because it interferes with the protocol.  Other anti-nausea drugs are ok.  

Have you spoken with many other women participating in this trial?  I have a hard time wrapping my mind around why so few participate.

Thanks so much.  
Barb
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Post Options Post Options   Thanks (0) Thanks(0)   Quote rigatonismom Quote  Post ReplyReply Direct Link To This Post Posted: Feb 02 2012 at 8:53am
Hi Barb,
I don't know about the emend.  I know I did have it in the premeds.  I guess it could have been something else but they told me it was emend.  Yes, I did have a port and still do.  I'm on the PARP arm and they haven't gotten the pills to us yet.  Another woman at my center is on the trial also.  The port does help because the treatments with Cisplatin take 3 hours for just the Cisplatin and you add the premeds and the PARP.  Hope this helps.
Nita
DX 09/10 TNBC Stage3c, grade3, Tumor 2.7cm, chemo started 9/29/10, AC x4, Taxol x12, lumpectomy 4/11/11-tumor .6cm, 3+/22 nodes, radiation x 30 finished 6/30/11.Clinical Trial Cisplatin,PARP 8/23/11
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