Clinical trial using Avastin for triple neg
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Topic: Clinical trial using Avastin for triple neg
Posted By: Alma
Subject: Clinical trial using Avastin for triple neg
Date Posted: Apr 28 2008 at 2:21pm
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I just ran across this Phase 3 trial today. The U.S. is not yet recruiting but it will be soon. Other countries have mixed status on that.
http://bcwatchdigest.evidencewatch.com/ - http://bcwatchdigest.evidencewatch.com/
| Sponsored by: |
Hoffmann-La Roche
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| Information provided by: |
Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: |
NCT00528567 |
Purpose
This 2 arm open-label study will evaluate the efficacy and safety of the addition of Avastin (bevacizumab) to standard adjuvant therapy in patients with triple negative breast cancer. Patients will be randomized to receive either standard chemotherapy (anthracycline +/- taxane or taxane only), or standard chemotherapy given concurrently with 1 year of Avastin (5mg/kg/week dosing equivalent i.v.). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
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Replies:
Posted By: cg---
Date Posted: Apr 28 2008 at 2:37pm
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I think it is called the BEATRICE study.
One of the women on this site (from the U.S.) is taking part in the study - taking Avastin for a year.
They are not recruiting yet in Ontario, Canada - but have started in other provinces.
Connie
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Posted By: aaklwalker
Date Posted: May 01 2008 at 4:58pm
I am on Avastin and Abraxane but not as a clinical trial. Am on second round, will have ct next week. Hair is gone, but have held up pretty well otherwise. Mets to lungs - this is 5th or 6th round of treatment, have lost track.
------------- Dx 1/06; Lt Rad mast 3/06; Reoccurrence rt lung; stage IV 1/07
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Posted By: ljmiller
Date Posted: May 05 2008 at 7:05am
I am on Avastin as "maintenance" therapy every 2 wks. along with 5 daily tablets of Tykerb. Hoping this combo will keep the beast away or progressing. Have not heard of anyone else doing this combo, but I'm sure praying it does it's job! Not sure how long the dr. plans to keep this up, maybe indefinitely, unless of course something comes up. Have a scan in a few weeks to see what its done so far. This is not considered a trial, though I'd be interested in knowing any results from Avastin. Anyone else on this combo?
FYI: Dx 8/04; Neo-adj ACT/Taxol, 36 rds radiation 3/07 Recurrence in adominal lymph nodes only; dr considers Stage V; no none bone/organs affected
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Posted By: CarynRose
Date Posted: May 05 2008 at 7:41am
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Ljmiller,
I'm on Avastin as 'maintenance' therapy along with Erbitux (EGFR suppressant), every three weeks via infusion. It's also not a trial, but rather something that my oncologist feels will work to keep cancer away for as long as possible. I'll be on it, as far as I know, until September, which will be 6 months that I'm on that treatment. I have some side effects (Oy, the ACNE), but so far, it's an acceptable trade off for NED.
I think Elizabeth on this site is on Avastin with Tarceva.
Cheers,
Caryn
------------- Orig dx 6/03 - St.2a, IDC
gr.3,0 nodes, TNBC/BRCA1+
7/07 St 4 mets to nodes/lungs. PACA/Rads NED 11/07-10/08
Lepto mets 10/08
Rads for 4 brain tumors 4/10.
Leptomets return 6/10
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Posted By: ljmiller
Date Posted: May 05 2008 at 7:58am
CarynRose, Good to know you are NED! Awesome! Is the Erbitux an infusion also? My Avastin schedule is every 2 wks. I'm fine with that as long as it keeps working. I'm slowly getting hair back from my last round of chemo combo of Taxotere and Avastin. Haven't so far (knock on wood) had any side effects of acne, but have had my share of diarrhea with the Tykerb, which immodium takes care of. Cheers to you! Stay well! Leslie
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Posted By: ForAuntie
Date Posted: May 07 2008 at 12:40pm
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Hello:
My first time posting...my auntie was diagnosed with cancer in February 2007. Had chemo, lumpectomy; more chemo; partial mastectomy; more chemo... Last pet scan showed the cancer had spread into lymph nodes and lung. She also told me recently that hers was considered triple neg. Her docs were trying to get her on Ixempra and Avastin, but insurance denied Avastin so she started just Ixempra this week. She will be going every three weeks... Is there anyone who has been approved for Ixempra&Avastin combo? Insurance is asking for clinical support to prove that this combo has efficacious but since Ixempra is pretty new, it's hard to find data... as all of you can imagine, this has been such a difficult time for my aunt and our family. We are an extremely close family which helps as we can pitch in to ease some of her stress and concerns...
Thanks.
Milaine
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Posted By: ljmiller
Date Posted: May 07 2008 at 6:28pm
Hi Milaine, When my dr. first put me on Avastin, he mentioned that if my insurance did not cover it, the drug company would. You should check into this since it has now been approved for breast cancer treatment. I'm not familiar with Ixempra but they may do the same. It's a shame that our dr's can be on top of the new treatments, but yet our insurance drives what is used/not used! I would check the websites for both drugs to see what the data says. Also check on breastcancer.org. for new info. Your aunt is lucky to have you help her research this crazy dilemma! Leslie
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Posted By: ForAuntie
Date Posted: May 08 2008 at 7:42am
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Hello Leslie:
Thank you very much for the information. We will pursue the drug co. avenue and hopefully they will cover the avastin. I really appreciate the information and will keep you posted on the progress. The insurance co. finally approved the Ixempra but her doc wanted to used it in combo with the avastin but not to waste time, they are just going to treat her with the ixempra for now and hopefully we can add the avastin soon to the regimen. Thank you again. Milaine
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Posted By: Barb T.
Date Posted: May 09 2008 at 5:34am
I am also on Avastin but with Taxol. It's not a trial. So
far, it's the only combination that has worked for me.
Unfortunatley, Avastin is very expensive. I'm lucky that my
insurance pays for it. Hopefully you will be able to get the drug
co. to pay for it for your aunt. I definitely think it's a great
drug for us.
------------- Barb T.
1st bc 3/03
New bc 2/06 with
Mets to liver/chest/lymph nodes
Avastin/Taxol
Avastin/Abraxane - 7/08
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Posted By: BrendaF
Date Posted: May 09 2008 at 5:55am
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The study posted is not for recurrence or metastatic BC, just adjuvant therapy.
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Posted By: julie
Date Posted: May 11 2008 at 10:34am
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I am going to do the trial for Avastin. I wish I knew if I were going to be getting the real thing instead of the placebo, but my oncologist said I would benefit either way since they would watch over me closer and I would have more tests done.
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Posted By: CalGal
Date Posted: May 12 2008 at 8:19pm
Hi -
Avastin & Abraxane is one combo I'm considering. How is this combo working for you? Have you had your scan yet?
I've been dealing with mets since 12/05, with 13 mos of that being NED! Unfortunately, my scan of last week showed more "progression".
Did you lose your hair on this combo - or one from before?
Hope you don't mind the questions - and that you're feeling good and the combo is working!
Thanks,
CalGal
------------- BRCA1
9/04 Bi-lat lump, clear SNB
38x Rad'tn
12/05 Recurr bc & mets to liver
06 the year of chemo
NED for 13 mos until 7/07
Lung met. PARP trial until ...
2/08 Liver mets again
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Posted By: Wendy2
Date Posted: May 13 2008 at 2:07am
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CalGal
I am doing Abx/Avast. Today will be third treatment. So far, so good, but I'm not too far along yet.
After much research and three opinions, I chose Abx/Avast.
Taxol/Avastin are recently FDA approved and written in New England Journal, but in my research Abraxane and Taxol are "sister" drugs and Abraxane is mixed with water which is more readily absorbed and is not mixed with cremphor, which also has side effects. My "private practice" onc. would not give Abrx/Avast. I believe because of insurance issues, however, any hospital will and I'm sure there are private prac. oncs. that will too. I have a friend that is cancer research scientist and her research also showed Abrax. to be a bit more tolerable. That's my two cents.
Still have hair, but think it will probably go or thin so much I'll wish it gone.
Wendy
------------- dx 3/06 TN, taxotere/cytoxin x4; radiation x 40; mets. to lungs, lymph nodes 3/08 - to begin chemo 4/29/08 Abx/Avas., 9/08 Avastin maintenance, 1/09 - off meds to see if Avastin causing headaches
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Posted By: Barb T.
Date Posted: May 13 2008 at 4:26am
Although I'm doing Taxol/Avastin, I have met a friend at my onc's
office who is now doing Abx/Avastin and doing very well with it.
She, too, had started out w/Taxol/Avastin but couldn't tolerate
Taxol. So, yes, it appears that Abrax. is much more
tolerable. Also, getting good results. However, my friend
has lost her hair. With Taxol, my hair is thin but I'm
comfortable not wearing a wig. I even have hair appts. to get it
cut!!
Good luck with the Abrax. I'm sure you'll do well.
------------- Barb T.
1st bc 3/03
New bc 2/06 with
Mets to liver/chest/lymph nodes
Avastin/Taxol
Avastin/Abraxane - 7/08
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Posted By: BrendaF
Date Posted: May 13 2008 at 5:12am
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CalGal and all, when I changed oncs in January after one treatment of carboplatin/taxotere, I asked the new onc what she would have used and she said Abraxane - Avastin. I was alread one tx into the carbo - taxotere so I did the series of six. But, fwiw, that would have been her recommendation.
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Posted By: ljmiller
Date Posted: May 13 2008 at 5:56am
In response to the question regarding hair loss w/Avastin: From what I was told about Avastin, it is considered "immunotherapy" instead of chemo. With the combo of whatever chemo you are on (mine was Taxotere) you will lose your hair; now that I am finished w/Taxotere but still have a bi-weekly Avastin infusion, my hair seems to be coming back! Hoping the next scan shows dramatic improvement!
"Life is not waiting for the storm to pass, it's learning how to dance in the rain!"
Leslie
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Posted By: CarynRose
Date Posted: May 13 2008 at 7:32am
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My hair's coming back in thick and strong after finishing 'chemo', but continuing with Avastin and Erbitux every 3 weeks.
Cheers,
Caryn
------------- Orig dx 6/03 - St.2a, IDC
gr.3,0 nodes, TNBC/BRCA1+
7/07 St 4 mets to nodes/lungs. PACA/Rads NED 11/07-10/08
Lepto mets 10/08
Rads for 4 brain tumors 4/10.
Leptomets return 6/10
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Posted By: Leese
Date Posted: May 13 2008 at 10:08am
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Hi Milaine,
Iam currently being treated with Avastin, Ixempra, and Zometa (for the bones). My insurance company has covered everything this far.
Leese
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Posted By: ForAuntie
Date Posted: May 13 2008 at 5:34pm
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Hi Leese:
Thanks for the info. We're going to try to get the drug co. to pay for the Avastin. My aunt is on ixempra right now and we'll see how that works in the interim. Ixempra has been pretty tolerable for her thus far, but she's only had 1 infusion and it's every 3 weeks. Let me know how you do on your treatment. All the best, Milaine
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Posted By: thinkpositive
Date Posted: May 16 2008 at 1:43pm
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Re: Abraxene & Avastin.... I was dx with lung mets in Jan 08 and did 3 months of A & A and then had a CT scan which showed that the larger spots were reduced by half and smaller spots were no longer visible. My hair had just really come back after 1 year off of chemo when I started with the A&A. It seemed to be thinning out so fast and was so annoying that I went ahead and shaved it. I have had very thin pitiful sprigs coming thru while on treatment but am just going to shave it until I am done. The side effects I have had are high blood pressure, nose bleeds, constipation and some fatique. I have been able to work fulltime thanks to WIFI at the chemo center and cell phone to stay in touch with my office.
I will continue on the same treatment for 3 more months and then another scan. Not sure where we go from there if the CT is clear. Sounds like I will probably be dealing with some type of maintenance treatment after this. Sure we like to have hair by Christmas !!!
------------- dx 3/06 stg II 0/7 lymph
bilateral mastectomy 7/06 AC/Taxol lung mets 1/08 Avastin Abraxene 02/08/9/08
Brca neg Avastin Xeloda 10/08
Curagen 2/09 Ixempra 6/09 Lung Mets
Gemzar/ Carboplatin 9/09
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Posted By: Barb T.
Date Posted: May 17 2008 at 10:23am
So glad to hear you're having such positive results!
------------- Barb T.
1st bc 3/03
New bc 2/06 with
Mets to liver/chest/lymph nodes
Avastin/Taxol
Avastin/Abraxane - 7/08
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Posted By: brena
Date Posted: May 20 2008 at 6:22pm
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ECOG is sponsoring trial E5103 which is a phase III double blind study using Avastin or a placebo. Hope this is the trial that proves Avastin to be advantageous to TNBC woman.
I participated in this trial but only received the placebo, I will still be monitored and compared to those who actually received Avastin.
http://www.clinicaltrials.gov/ct2/show/NCT00433511?id=E5103&rank=1 - http://www.clinicaltrials.gov/ct2/show/NCT00433511?id=E5103&rank=1
brena
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Posted By: trip2
Date Posted: May 21 2008 at 2:10am
Thanks Brena for sharing the information and welcome.
------------- Stage 2 2003
Stage 1 2007
BRCA 1+
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