The ATEMPT clinical trial has been going on for several years.
Are you participating?
The recruiting period is over. The planned participant level of 500 has been met.
I officially enrolled yesterday and will hear which arm I'm in either next week or right before my first scheduled infusion Dec 2nd. I am also juggling insurance issues as I am a Kaiser member and the study site is at UC San Francisco - across the Bay from me. My first oncologist resisted referring me, saying T1a didn't need any her2 related treatment. The next two I consulted said it was absolutely a good idea and referred me so Kaiser will indeed pay. I do have to do all labs and imaging at Kaiser, but it's been easy to get results over to UCSF where the study is. So far had blood work, cardiac echo and EKG - all ok thankfully. Still waiting for a port placement appt. because I didn't want one initially but the chemo nurse talked me into it even though I have good veins. She said no more sticks on the surgery side ever, so don't risk subjecting the veins on the other side to damage from chemo. Her2 confirmation by Dana Farber took a couple weeks but now confirmed. So back to waiting mode, for the randomization and port placement. This cancer world we are having to learn sure is a test for patience!
I began the trial on 10/16. I did get the Kadcyla arm of the trail and so far so good. My 3rd treatment is this Wednesday. I travel 2 hours to get to the hospital which has been doable so far, but I am not so sure how it will work out once radiation starts after the first of the year since the radiation center is local.
My worst complaint so far is with my port. I did my first infusion without one and it went fine, but was convinced by the nurses to go ahead with the port placement. I had the surgery on 11/3 and did my 2nd infusion on 11/6. No problem with the infusion, but I have had a good deal of pain in my right arm/upperchest, sometimes into the right side of my neck. I have a follow up appt with the surgeon on 12/2.
Thanks Maggiecat for starting this thread!
hi Bernie- great to hear from someone ahead of us in the process! Have you had any SE from the Kadcyla? Do they give you any pre-meds? RT and infusions at places two hours apart does sound like a long day but hopefully they will both cooperate to help you with timimg. Will you be able to do the shorter (~3week) RT regimen? My RO says it's just as good as the longer regimen and no worse SE.
Your comments re port pain are giving me pause. I didn't want one either but the chemo nurse is pushing. Maybe ill stall at least til after the first treatment and see how it goes. Chemo nurses might be a little biased toward what is easier for them. Because of my insurance I have to get blood draws at a different place and they won't use the port at that lab, so I would get less use from the port anyway.
I'm really impatient to hear which arm I'm in- it's already been over a month since starting the trial application process and wierd knowing I may show up for my first infusion still not knowing what I'll get!
Thanks Maggie for starting this and Bernie for joining in! I'm happy to have some trial sisters to go through this with!
I am pretty fatigued the 3rd day after the infusion. I start to rebound on the 4th day. I have dry mouth, and was only nauseated once so far. SE's from the treatment hasn't been bad at all. No pre meds are given. My first infusion was 90 minutes and they kept me another 90 minutes for observation. The following infusions are 30 minutes with 30 minutes of observation.
I didn't find out which arm of the trial I was getting until I arrived the day of my first infusion! Talk about nervous! They were waiting on the results of the 2nd lab report on the HER2 status - I believe she told me that two labs have to confirm the HER2 status for the trial.
I will be getting Intensified Radiation - 16 treatments instead of the typical 32
I know several people who have had ports and none have had any problems. I think I am just a special case...I am thin in my upper chest/shoulder area. My Primary Care Physician told me to gain weight and that would help....
Hoping others will join in the conversation! I hope you get the Kadcycla arm of the trial.
Found the other group of ATEMPT ladies that I read posts from.... They are months ahead of us.
HER2 Support Group Forums > Newcomers Club / Welcome Wagon New Here, started TDM1 trial last week
I found out today that I was randomized to the Taxol/Herceptin group. I knew it was possible, but had really hoped to get in the 75% assigned to the TDM-1 arm. On top of that my visit at UCSF was really discouraging. The parking garage gouges - $30 for the clinic visit. They kept me waiting for well over two hours undressed in a cold exam room for 15 - 20 minutes with the oncologist and the medical assistant said that's how it is all the time. So they schedule the clinic visit 2 to 3 hours before the chemo which also takes many hours. With an hour and a half commute each way - I'm not looking forward to doing this every week for the next three months especially when I can get the same treatment 15 minutes from my home. I'll have to figure out just how generous I'm feeling about participating in the trial since at this point it is a hardship for me with no personal benefit. Maybe I'll feel less selfish when this sinks in further.
I am so sorry you didn't get the TDM-1 arm of the trial. And it stinks that UCSF is so discouraging. $30 parking is ridiculous! My parking is paid for at IU - Indianapolis. I do have a two hour drive (I live near Louisville) but the wait isn't so bad after I arrive.
Thanks Bernie for the sympathy. I really thought I was mentally prepared for either option and surprised myself with how disappointed I was! But I'm moving on, will see if there are any good on line Black Friday head covering sales!
I am afraid the side effects are starting to kick in. A few weeks ago, I had terrible stomach pains that wouldn't go away no matter what I did. They finally left on their own. Well, now the stomach pain is back. So bad that I can't sleep well at all. Last time, they suggested I take Tums - which made no difference whatsoever. I ate probably 20 of them...
Hello Bernie... I sure hope this finds your spirit and body in a better place!!!
I find out Friday which arm (if heart and blood tests are ok on Thursday). First chemo is planned for 12/16. I read up on the SEs for T-DM1. Honestly think the targeted therapy is the future but do wonder about the SEs and how much understanding there is about what to do.... Your tums comment fits with my thought.... So sharing the best I have found....
" As expected based on the well characterized toxicities associated with the respective components of these regimens, the most common AEs (>20%) reported in the T-DM1group of the pivotal study were nausea (39.2%), fatigue(35.1%), thrombocytopenia (28.0%), headache (27.1%), diarrhea (23.3%), AST increased (22.4%), decreased appetite (20.6%) and epistaxis (20.2%)." http://www.ema.europa.eu/docs/en_GB/document_libra...
A couple other thoughts for you Bernie - remember not all symptoms are chemo related - things like gall bladder trouble, appendicitis etc can happen to anyone. Hopefully it's nothing like that but do go in to an ER or your doc if you don't feel better. Also nausea meds cause big time constipation - and constipation can cause some pretty awful stomach pain, just another thing to consider if that's been a problem for you. If you changed up your diet in response to either the cancer or the chemo side effects, that can cause stomach pain too. I usually eat pretty low carb but because of the low grade nausea/funny taste I've been eating a lot of starchy bland stuff, and lo and behold the chronic stomach pains I had that had long since disappeared with low carb eating came back - took me a minute to realize what was going on. Upping fruits and veges quickly can also cause stomach discomfort. Anyway, just a few thoughts - hopefully you are already much better!
I am in.... not sure which arm... testing done..
glad you are in the trial Maggie. I have been off work all week with terrible stomach pain. Per the nurse in Indy, this is not a SE of the kadcyla. Saw the nurse practitioner at my local doc office yesterday. Have an appt tonight at 6 pm to get a ct scan. I had my gallbladder removed 20 yrs ago. Of course I am actually finally feel g better today.
I'm T-DM1......... hope your stomach pain is better, Bernie.
How are you doing Bernie?
Had port placed today. So far not too sore.
Johara: I hope your port continues to be problem free as well.
Maggie: Glad you got the TDM1 arm
I am feeling much better - still waiting on CT scan results. I guess no news is good news. I lost 14 lbs in 7 days... I think it is a combination of the chemo and tummy troubles - I have absolutely no appetite whatsoever. Couldn't even force myself to swallow a bite of solid food. I drank a few milkshakes and would eat a few spoonfuls of broth.
I go in for round #4 on Thursday Dec 18th....
Thanks Bernie - had one very rough night post port placement, but on the road to recovery now. I'm so sorry to hear of your GI issues, sounds truly miserable. Can you tolerate Ensure type drinks for a little liquid protein? Sounds like you have some nutritional catching up to do! I hope Thursday goes well and doesn't add any more to your tummy troubles - I'll be thinking of you! It sounded like TDM-1 was pretty easy on the stomach as it is so targeted so hopefully it won't give you any more trouble than you already have! Let us know how you are - we trial sisters have to stick together, even if we are in different arms!
I had my 4th infusion yesterday. All went smoothly. I am feeling much better and am able to eat again. I lost a total of 14 lbs. I believe the cause of the pain was constipation... I have never dealt with with that before, and was quite surprised at the amount of pain it caused. My CT scan showed everything was normal and my GI Enzymes were also normal.
I also got the go ahead to start radiation - so I need to contact my RO again.
TTfan - when do you start your treatment?
Maggie - how did round #1 go?
Have a great weekend!
So glad you are feeling better Bernie! Yes, constipation can cause really nasty pain. I still remember how it felt from pregnancy and postpartum and that was a very long time ago! Don't know if you take or even believe in probiotics, but those and a magnesium supplement have prevented any constipation issues for me.
I have had three of my weekly Taxol/Herceptin treatments. Each time was a little different, but other than losing my hair this time is , knocking on wood, the easiest so far. I even went to a yoga class this AM for the first time in years and felt pretty good. I've learned to take the Zofran before the nausea gets bad, graze regularly and drink tons of fluids. Seems to be helping me not be so wiped out.
Hope the RT is easy for you. Other than the inconvenience of the daily trips, it seems to be for the majority of women so here's hoping! Will you get the shorter dose intense version or the traditional longer one?
Hello Bernie....good to read things are better for you!!!!!!!!!
I'm only a few days out from the first infusion. I have a happy bowel usually and can tell I need to manage that aspect of T-DM1... Please share any advice you were given! I brought home meds for loose stools and the package is unopened! Started eating a handful of raisins yesterday.... may need to buy prunes!
I experienced an infusion reaction ( who knows, but that was the comment back from the research nurse). Kind of a strange mix of chills, flushing face and headache after the first infusion, not at the hospital... about 8 hours later. ( At first I thought it was the Bojangles iced tea I had coming home ( 3 hour drive...) keeping me from getting to sleep.... then,just a really strange mix of stuff going on... Things were normal the next morning.
Best wishes for a peaceful holiday for ya''ll, Bernie and Johara!!!! Just think, this time in 2015 life will have returned to something closer to "the norm"!!!!
Hi, Maggie, Bernie, Johara, I never posted before, but I saw this thread and had to write! I finished the Atempt trial at dana farber this past may, had the kadcyla arm (I think I may have been one of the first to finish it). Overall I tolerated it pretty well, main side effects were nausea, fatigue, that mostly went away after a day or so. I did have a rash which was worse after the first couple of infusions, but it seemed to get better after. I think overall the side effects seemed less the further I went along with it, if that's any consolation. I didn't have a port, just an IV every three weeks. I had the typical bumps in liver enzymes and drops in platelets but nothing that gave me a dose reduction. I really hope that it goes well for all of you too, regardless of which arm of the trial you have. If you have any questions, or if I can help, you can PM me too. It seemed like a long year, but then it was over before I knew it too! It's nice to see this thread because I was searching for anyone who had a similar experience. I feel awesome now, and lucky that we have targeted therapy for Her2. Hope you have a nice holiday too, and have some time to relax! Johara, even though you have taxol/Herceptin, the data presented last year was so good for outcomes with that treatment, almost zero distant recurrences, even at five years, it almost made me question if it would be better to have "tried and true" taxol/Herceptin. I think we are all getting good therapy.
Welcome Emily - I am glad you found us and posted your experience with the TDM1 trial. I am glad this was a positive experience for you without too many bumps in the road. Did you have any trouble with losing your appetite? I am still struggling with this.
Johara - I will be doing the shorter 16 days of intense rads. I have to go back in to talk to the RO on 1/5. I have an overnite meeting in Cincinnati for work on 1/13, and I am hoping we can start rads after this meeting. I didn't realize you had already started chemo - glad it is going smoothly for you.
Maggie - I am glad you infusion reaction didn't last too long and all seemed to go fairly well for you.
Merry Christmas and Happy Holidays to all!
happy holidays everyone!
Emily, thanks for sharing your experience, it's great to hear from someone on the other side of this! And thanks also for the words of encouragement about the arm I am in. I agree we are all getting good treatment. I could do without the being bald part of this though! It's cold! My scarf wrapping skills are improving daily though.
I don't know if you get the steroid preload before the TDM1 like I do before TH. It gives me about 48 hours of good appetite which I made full use of tonight at a family dinner. The next few days will likely be back to mild nausea and little appetite but I think I ate enough tonight for rest of the week anyway!
Off to bed now, I wore myself out eating and socializing but definitely wanted to check in and wish you all the best holiday you can muster up
T-DM1 early results from the Marianne clinical trial. Three arms, two the same as ATEMPT.
A second link from a stock market perspective....
Interesting articles, thanks Maggie for linking them. How much do we pay as a society for more expensive new drugs with similar efficacy but a somewhat better SE profile? My hope is that the genomic testing will get more sophisticated and we will know from tumor analysis which drugs will be best for a given person. Then the cost starts making more sense.
Maggie, you must be just about due for round two - thinking of you and wishing you no infusion reactions! Hope you've had some happy healthy holiday time between treatments!
Yup... Tuesday is round 2. I sacrificed my favorite knit shirt last time (apparently left in the hotel room). This time we can make it a day trip. Who knows about the next trip, early morning and late January! .... So, I'm looking more at the radiation time. It comes after week 12. I'll have to stay away from home for 5 days a week for 4 weeks. I type this as my alpha female Maine Coon kitty looks at me...not so sure my better half knows what he has agreed to!!!
Wow, I wouldn't be looking forward to that travel, away time either! Are there no closer rad facilities to you or did you not trust the local ones?
I've never had a Maine coon cat but love the look. I have heard they are feisty though. From the little I know about you, I'm guessing the feistiness is a good match and something you relate to!
Good luck Tues and the next days!
Hope everyone is doing well. Me, not so much. I had another round of stomach troubles again. They have ruled out pancreatitis. And my gallbladder was removed 20 years ago. I am now waiting to get an appt with the gastrologist. My oncologist insists that it has nothing to do with the chemo...I am not so sure. I have lost another 10 lbs. I really cannot afford to lose much more. My appetite is zero.
I am meeting with the RO once again today. I am past the 12 weeks and need to get moving on that. Fortunately, I will only need 16 treatments (intensified) and I will be able to do that locally.
Maggie, I hope your treatment tomorrow goes well. I head to Indy on Thursday. Unfortunately, the doctor will not be there, but the nurse practioner instead.
Bernie... Darn stomach...know you will rest better once a cause is known and effective treatment can begin.... Pleased to hear not pancreatitis. I lost my big brother (13 years older than me, I was a late life oops) December 2013 to pancreatic cancer. We may not like the challenge we are facing but surely don't want to add issues with the pancreas to the mess.
Radiation... will have it at UNC-CH where I am doing the clinical trial. Initial feedback from the ATEMPT sponsor was I would need to have my radiation treatment performed within their complex. Might have been something to push back on. (MD Anderson did not have that requirement.) Husband pleased with the initial RO meeting/discussion, especially time taken to review partial breast vs whole breast and heart/lung considerations for left breast treatment. So, he is much more comfortable with me being treated there.
Good luck to each of us this week !!!!!!