ATEMPT Clinical Trial - Roll Call
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EILEEN - The ATEMPT trial.....
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved this drug for use patients undergoing adjuvant treatment for HER2+ breast cancer. Trastuzumab emtansine (T-DM1) is a drug that may stop cancer cells from growing. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to prevent the recurrence of breast cancer in this research study.
The use of T-DM1 in this research study is experimental, which means it is not approved by any regulatory authority for the adjuvant treatment of HER2-positive breast cancer. However, it FDA-approved for metastatic HER2-positive breast cancer. T-DM1 has caused cancer cells to die in laboratory studies. In preclinical studies, this drug has prevented or slowed the growth of breast cancer. The breast cancer treatments (paclitaxel and Trastuzumab) used in this study are considered part of standard-of-care regimens in early breast cancer. A standard treatment means that this is a treatment that would be accepted by the majority of the medical community as a suitable treatment for your type of breast cancer.
In this research study, the investigators are looking to see if the study drug T-DM1 will have less side effects than traditional HER2-positive breast cancer treatment of trastuzumab and paclitaxel. The investigators are also hoping to learn about the long term benefits and disease-free survival of participants who take the study drug T-DM1 in comparison to those participants to take the combination of trastuzumab and paclitaxel.
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thank you
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Thank you for the positive, encouraging note IsabelArcher!!! Its too bad DFCI doesn't have a network to connect for this trial!0 -
Hi everyone - so I just met with my doc yesterday about participating in the TDM-1 trial (vs. the taxol and Herceptin) and am having a hard time deciding - how did you all make your decision if you decdeied to participate (even if you got selected for the taxol arm of the trial) - and if you did do it - how's it going???!!!! It looks like it's 2.5 years into the study - I am intrigued about doing LESS but worried about the not knowing the outcome - i had a HER2+ 6mm tumor that was removed with mastectomy (because also was a large DCIS)......anyway - any insight to help this indecisive person decide.....did you hear that there was great promise for this drug? what have your side effects been? any info..............please...need to decide soon as I am going crazy!
best to all of you.
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NC Girl - Welcome! You have a running dialogue here, in these 3 pages, of the SEs experienced over the last few months (and also some comments from trial ladies that have finished). The decision was an easy one for me. I did my homework on Her2 (3+) and found the ATEMPT trial. I was evaluated at two outstanding research hospitals . It was the recommended approach at both. I drive 2 1/2 hours each way for treatments. No downside on the treatment available no matter which study arm I was assigned, either w/ taxol/herceptin or T-DM1. I am receiving great medical support and find some peace of mind being in a group that will be followed for 5 years. Oh... worth mentioning, I also was evaluated by a local MO. His plan was taxol/herceptin. In the end I was assigned to the T-DM1 arm.
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Thanks to all of you who responded - it's helpful to know your thinking - am waiting to talk to 2 more people - my surgeon and a family friend oncologist who specialized in breast at NYU but they are not doing the trial there but am sure he knows the deal......anyway - I am sure once I get excited about it - I'll get put in the TH arm -but maybe then it's just meant to be....who knows - this whole journey - since lump finding on Nov 7 while bra shopping with my 13 year old (initial dx was DCIS -and then they realized it was large so then mastectomy - thank god because I was starting to HATE that breast anyway - and that showed the 6mm invasive HER2 tumor - BLECH - so just scary....I've not been myself and have 3 girls 13, 11, 7 (negative for BRCA1 and 2) - but just hate how life has been turned upside down and this is all i think about now......thanks to you all - especially MaggieCat for your scientific expertise - sounds like they really believe this is the way to go - and there was an option - though not recommended - to do nothing....but I never really considered that - I must say - GET IT ALL - whatever it is....
lots of gratitude for finding you all
Amy
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Emily - I tried to message you privately - but it didn't work - my email is charney98@aol.com - if you write me - I'll send along my email back to you.
Thanks - Amy
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hi Amy, I am two months into the trial and in the Taxol/Herceptin arm. I was initially very disappointed not to get into the TDM -1 arm, and even considered withdrawing from the study since I could get that treatment much more conveniently closer to home. After a few days of thinking about it though, I realized I really wanted to contribute to more knowledge in this area, especially because it was such a struggle for me to figure out what to do in our somewhat unique situation. The balance between the positive aspect of the tumor found small, with the negative aspect of the known aggression of her2 tumors has caused a great deal of disagreement in the oncology community. The very first oncologist I was assigned to at Kaiser strongly suggested not using Herceptin or chemotherapy. Because I am also hormone positive, she felt treating that aspect of the tumor was sufficient for what she felt to be very good outcomes. Like you, however, I was not comfortable without hitting this tumor with everything reasonable we had available to us. I consulted a few more oncologists who agreed with my decision and agreed to refer me to the attempt trial. The second one I spoke with was also originally somewhat reluctant. After a moment of silence as we were both thinking, my partner asked her if she had ever seen patients with a small Her2 tumor my size, who had metastasized after hormonal treatment alone. We could see from her face what a traumatic experience that had been as she said yes she had. She quickly became an enthusiastic supporter of referring me to the attempt trial. I did consult a third oncologist, sort of as a tiebreaker, as I wanted to be sure I was not talking myself into more toxic therapy then I needed out of my initial fear shortly after diagnosis. She made sure I really understood the risks and benefits of the chemotherapy, and then enthusiastically referred me, and took over my care as I share it between my local Kaiser facility and UCSF where my closest trial center is.
I would say the first eight of the 12 weekly Taxol/Herceptin treatments were relatively easy. I had a few side effects, was tireder than usual, but was able to work a fairly demanding job throughout the eight weeks and was confident I would breeze through. Week nine hit me like a ton of bricks, when I had every side effect in the book though none of them serious enough to have to delay the chemo. I did have to stop working however, though that has turned out to be somewhat of a blessing. I am able to take care of myself much better and week 9, while still hard, was not as bad as week 8. I had my 10th infusion yesterday, so we will see how this week goes. Being off work, and with the end of the Taxol in sight it all seems a little more manageable.
You can see from this thread that the TDM-1 has not been a walk in the park for some women either. Several have had to stop early due to side effects. Despite my initial disappointment, I can now see that either arm is a very reasonable choice. I wish you the best of luck with finding the right medical team for you and should you join the trial, I hope all goes very well for you whichever arm you end up in.
Please keep us posted whatever you decide!
Warmly,
Johara
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TTfan, just want to say I'm glad you opted for the treatment of the HER2. (I was one of the TDM1 patients.) I wanted to be proactive in killing any stray cancer cells, and it sounds like you felt the same way. At the same time, it's important for women in our shoes not to overtreat. Early stage HER2 is better understood now, so treatment recommendations have changed, and for that we can all be grateful.
What you say about our being in a somewhat unique position is true. From what I understand (I had conversations about this with the research nurse working with the oncologists on the trial), what makes us unusual is that our HER2+ tumors were found very early, when they were still tiny (my favorite word--it counteracts the scary words "tumor" and "aggressive") and before they had spread to the nodes. By the time HER2 tumors are found, they have usually gotten bigger and spread (similar story with triple neg). So enrollment in the ATEMPT trial (when I was in it, 2013-14) was going slowly--there just aren't that many women who qualify. I believe they were aiming for 400-500; does anyone know what current enrollment numbers are?
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Thanks Isabel, I too have no regrets about choosing the trial despite feeling pretty lousy at the moment. I know this will end and am willing to put up with it knowing that even if only by a little, I'm decreasing the chances of facing all that stage 4 would mean. I also agree that more and more information is out now about these tiny tumors. If I remember right, I was told the number of nationwide attempt trial participants is in the low to mid 200s now. As mammography technology improves, there will be more candidates though, and with them more and more need to get this treatment decision right. Right now I see on BCO that oncologists around the country recommend everything from the most toxic therapies to no therapy for small her two tumors. Given that dilemma, I chose what I thought was a reasonable middle ground.
We/they really need to figure this out! in the end, I suspect the answers are going to come out of improved personalized genetic tumor testing that is currently not available to HER2 positive women. I am hoping that is part of what they are with the "study tubes" of blood they draw during the trial.
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TTfan, you wrote: "Right now I see on BCO that oncologists around the country recommend everything from the most toxic therapies to no therapy for small her two tumors. Given that dilemma, I chose what I thought was a reasonable middle ground." This is so true--the wide variety of treatment recommendations--and it drives me insane, because TH has become the standard of care and yet not all oncologists across the country seem to know this. It breaks my heart that women are getting tougher chemo regimens when they don't need them. If you need them, you do what you gotta do; but if you don't, you shouldn't have them. The first onc I saw was going to give me ACTH--as she put it, "the big guns." Made no sense to me that I would be treated the same at stage 1 as if I were stage 4. Second and third opinions were the best things I ever did, and I strongly recommend getting at least two opinions (as you did) to everyone!
And I hope you will feel better soon and be able to put this behind you. I had zero problems with Herceptin after I stopped getting the TDM1.
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i am going to sign my consent form tomorrow for the trial - and then we'll see what happens after they confirm my path and i have the blood work etc...if I get TDM-1 - great and if I get TH - then I guess that was meant to be......either way this whole BC thing just sucks so bad......so scary and I hate it....
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NC Girl - Yep, this unexpected detour sucks! Let us know how things are going as you find your way through this next few weeks. It WILL get better...
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There's no other way to say it--BC really does suck and I hate it too. But you've taken a positive step, and you will be benefiting, as we all have, from the amazing developments in HER2+ treatment. I hope you have the most minimal of SEs, whichever arm of the trial you're assigned to.
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it's funny - now they know at UNC we "know" each otehr without mentioning your name of course......who did you say your doc was?
when are you there next? maybe we can meet? have you met any of the others on the trial there?
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NC ... Guess you signed??? Take a moment and breathe deeply... you've joined an amazing support team!!!! It will get easier. I'll send you something more about my schedule, etc. later today..... Maggie
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so wondering - do ya'll have ports? for either arm of the trial? I won't find out which arm I am assigned to until feb 20 or 23....just signed today and path being sent out and then heart and blood work on the 19th - but do I really need a port? I hate the idea of it - wondering what you all have done and what was advised to you?
thanks!
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Thanks Johara - that's very helpful - I feel like whichever arm I get selected for - I'll be in good hands.....though at the moment I am leaning toward wanting the study arm more - but also feel like how can I go wrong with status quo......wondering if you've lost your hair? all of it? is it guaranteed? I know it's just a side effect.....and not the worst thing - but I was so hoping my biopsy - which showed DCIS (twice) would have just stayed DCIS and was VERY disappointed with the invasive - albeit small - HER2+ thing there too...but i ugess lucky I presented with a lump becuase none of it showed on mammo because of dense (itty-bitty) breasts!
Amy
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NC--no port for me. At Dana Farber they try to get you through without one, and it worked for me the whole year even tHough I have small, difficult veins. I would recommend that you insist on trying it without. If you developany trouble with your veins, a port can be placed later.
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re ports, I resisted at first and got my first two infusions without one. The chemo nurses all tried to talk me into getting one, and I eventually listened to them. Their argument is that no matter how good your veins are the repeated infusions and blood draws on the same side will eventually wear them out especially since the side the breast/node surgery was on is no longer an option. Now I totally love my port. I rarely think about it other than infusion times. It's so nice to have both arms free during the infusion and not attached to an IV. Not to mention it hurts much less than an IV start.
Re hair, Taxol is not an all or nothing proposition. The majority of women get very very thinned out but don't get the shiny bald look. You also have the option of using cold caps if you wish. They appear to be very successful in maintaining hair as long as you don't mind a little brain freeze. I had no interest in the brain freeze, I can't even eat ice cream without getting a headache so it sounded awful to me. My hair started shedding substantially by about the third week and I ended up clipping it down to about a quarter inch. I hated seeing my hair falling in clouds behind me so the extremely short cut was easier on me emotionally. I did cover my head with scarves at work, but often sport my bald head at home and even out and about these days unless it is too cold. I could probably have waited several weeks longer and other people would not have noticed all that much. But to me, used to very thick hair, the very thin hair screamed cancer louder than my bald head does. This week after 10 treatments almost all of it is gone except for a little stubble. I have some fun with lots of colorful scarves learned lots of ways to tie them on the Internet, but it does get old after a short time.
Yes, cancer truly sucks!
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I have one (port). Trusted my breast surgeon's advice. We talked through the install at my post surgery appointment. Really don't know its there any longer other than when using it or going to Yoga! I learned I needed a "high and tight" sports bra for the down facing yoga positions. Several of my favorite yoga tops are at the top of the closet until winter 2015. Will pull them out again after the "end of chemo bonfire".. Note to self - add the high and tight tops to the burn list!
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I get a kick out of your bonfire references. Maybe all us year long treatment girls should meet up for a really BIG bonfire together! I could host and we could do it on Ocean Beach in San Francisco.
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TTfan ... hitting the like button!!!
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A friend bought me a colorful tote bag to take to treatments--the classic chemo tote. When I finished the treatment year, just looking at that damn bag made me nauseous. I had developed a visual association between the bag and the queasiness I felt after the TDM1 infusions. Instead of having the ceremonial chemo burn, I sent it to a friend who was beginning chemo for uterine cancer. Chemo recycling! (If we don't laugh we'll go nuts, right?!
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Hi everyone! Just wanted to join the roll call as I'm finally making progress toward being part of the ATEMPT crowd. And why on earth can't they call it the SUCCEED trial or something that exudes confidence? All joking aside, I will be participating through MDACC and my clinical trial nurse has made it through insurance hurdles, co-morbities, other meds I take and now has sent my slides to central path for confirmation. Will take a little while as my surgical path IHC was equivocal, but FISH was HER2/neu +. Should be doing echo/labs as soon as central path is confirmed and beginning tx around 2/24.
If anyone else is seen at MDACC let me know and we can look for each other. Thanks to all of you for sharing your experiences to date. While my journey may be different in some way, it is reassuring to me to be able to read about your experiences. Wishing all of you the best, and Johara I'll be celebrating the end of your chemo soon!
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Welcome Mom2three... I was evaluated at MDA(not CC) and chose to do the trial closer to home.
LOVE the idea of " SUCCEED" trial. That is a keeper! Doing our best to get the word out... do what you can at MDACC... Seems we provide pretty amazing support to each other. ( That's my feeling anyway...)
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hi there mom to 3 boys - I am mom to 3 girls (13, 11, 7) and we are on the SAME track.......very similar diagnosis - was DCIS - or so we thought until mastectomy showed 6mm her2+ thing.....UGH! was so disappointed......just wanted the DCIS - ugh - and now starting on the same time frame as you but am in NC - but signed consent on Thurs so tissue at lab and due for heart and blood work on the 19th and then find out 20 or 23 which arm i'll be in.....and start 26th - are they recommending a port for you.......? i don't want one....but sounds maybe a good idea....
anyway - sorry you're here - but glad for the support - how old are your boys...?
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Thanks for the welcome. Yes, study sponsors and researchers should come to us for catchy names. After all, we are the target audience...haha.
MaggieCat, I generally talk with everyone I meet and will definitely introduce a few to our online resource here. Will have my laptop with me for those long days of tx and I believe the nurse told me they try to have all ATEMPTers infused on Wed or Fri. Like you, I think this is an amazing resource and source of support.
NCGirl, we are very similar! Like you, I was so disappointed when the IDC made its debut on my surgical path. After surgery, I was on top of the world. Minus two breasts but feeling like I had kicked cancer to the curb. HER2+ really threw me for a loop. I'm so thankful to finally be making progress toward the trial although it will be almost 90 days post surgery by the time I get started. The delay freaks me out quite a bit.
My 3 boys are all older than your girls. The oldest passed away last March at age 31 (he had muscular dystrophy and docs told us he would be fortunate to live to be 16), middle son is 20, a senior at Ole Miss while my "baby" is 19 and a junior at BAMA. I only get to enjoy girl time via their girlfriends! You must have your hands full with school and activities at your home.
Hope everyone has beautiful weather to enjoy this weekend!
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Mom2three...Welcome to the Atempt thread! So sorry to hear about your son that passed away! I can't imagine how hard that must have been/be, and now you are fighting your own battle and with humor no less! You must be one amazingly strong woman!
I came close to having the DCIS to IDC switchup you did, but the radiologist who did my core biopsy actually got the tumor in the initial biopsy along with the DCIS. So no one had even talked to me about the possibility of invasive cancer. The biopsy was "supposed to be" benign vs DCIS. I got a call from a nurse practitioner in the middle of a really busy labor and delivery shift, saying we have had a big surprise, you actually have invasive cancer and need to come in right away. So I didn't get the post-op surprise - just more DCIS there, but that first biopsy result really threw me for a loop as everyone had been so reassuring about it being DCIS at the absolute worst. I guess there's just no good time or way to find out.
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Mom2three, TTfan, and others--I'm also in the club of those who initially had a DCIS diagnosis, only to discover after mastectomy that I had IDC. All those conversations reassuring people about the almost 100% cure rate of DCIS, and then letting them know the situation had changed... And even before the DCIS was found it looked like I only had Paget's disease of the nipple. So the ups and downs were hard to take. In the end i had Pagets, DCIS, and IDC all in one breast. As a friend of mine said, i won the booby prize! ;-)
Mom2three, I am so sorry about the loss of your son. My two sons are close in age to yours--23 and 20.
NCgirl, just want to say again in case you didn't see my comment above, that I never had a port and did extremely well without one despite small veins. Like you, I really didn't want one. I understand that some women prefer them or need them. But if you don't want one, you should tell your doctor this
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