how long is too long to wait for a trial?
 

I was DX in October with DCIS, ER-, PR- Her2 3+, KI-67 20% In November I applied to an immunotherapy trial and was accepted! However I was told because of the holidays (Christmas and new Years) I would receive a call after the first of the year to set up a time to come in. Last week I was told that the research group is moving from their current location to another location. They really didn't have any details at that time, and I was informed that at the end of January they would have more information on what exactly that move would mean as far as the trial went. So, here I am. I have waited since October with this darn DCIS that could "go south" at any moment and most likely has grown in the meantime. I feel like I've waited long enough and perhaps should just walk away from the trial and head to surgery. However this trial also has an INCREDIBLE pCR rate for Her2+ so I'm torn. Any thoughts or suggestions? Or information? I could use any information that anyone might have! Thanks

Re: how long is too long to wait for a trial?
 

I would contact the drug company, not just the investigating doctor. Perhaps there is going to be another site? And maybe ask your own oncologist to contact the investigating doctor and see if there is more behind the scenes info.

I'd be PISSED!!!! And I'd be sending at least one letter, talking about the measured risk you are taking because they led you to believe you'd be starting treatment soon. When someone gets a letter that is clearly the start of a paper trail, they worry lawsuit and may respond in a more responsible way. I'd also cc your doctor/s and the drug company, and anyone else available to cc, like patient advocates or any government agencies. MAKE SOME NOISE!!!

Re: how long is too long to wait for a trial?
 

I would complain but this is the only center doing the immunotherapy for this. This researcher is the only lab making the vaccine from the individual T cells for early stages. Everyone else requires stage 3 or 4. Not that I want to be stage 3 or 4, but it just feels like I've waited so long, letting this darn thing grow while I waited to get into this trial. I contacted my oncologist who ordered a new diagnostic mammogram to compare to the one from November. Really hoping we don't see much spread.....but? I still don't know what to do. I will give the trial until the end of January to see how long the delay might be and then have to make some serious decisions. I'm just wondering if I should even give it two more weeks.....

Re: how long is too long to wait for a trial?
 

I'm afraid to make too much noise. I don't want them thinking I"m a trouble maker and running the other way! I sure don't want to be turned down just because I cause too much noise!

Re: how long is too long to wait for a trial?
 

I have been looking for a drug trial I could enter while I am NED. Which one are you referencing and where was the location before it moved? I would really appreciate any information you can share.

Re: how long is too long to wait for a trial?
 

Make noise!!!! Be a lady, always, but express your distress from your gut, explaining the urgency of the matter and the additional psychological suffering of waiting with cancer. Cancer grows exponentially. Get moving on this. You are a walking, living, breathing emergency.

Listen to Flori... Please... Put it in writing. Today. Make calls. Now. Get on it. Where do you live? If you had to drive a few hrs for the trial would you be willing? Able? Trials seem to move locations. One in Pa. is coming to Tampa I believe. You never know. Get on it. No one loves you more than you. If you don't speak up, who will? Offices and docs are busy. Your a name. They don't know you. Make yourself known. Please.

Sent with more love than alarm,

Andi

Re: how long is too long to wait for a trial?
 

"Listen to Flori... Please... Put it in writing. Today. Make calls. Now. Get on it. Where do you live? If you had to drive a few hrs for the trial would you be willing? Able? Trials seem to move locations. One in Pa. is coming to Tampa I believe. You never know. Get on it. No one loves you more than you. If you don't speak up, who will? Offices and docs are busy. Your a name. They don't know you. Make yourself known. Please."

Actually this is the very trial I am talking about. I was admitted to the trial but because of the move, there will be a delay. They don't know how soon the lab in Tampa will be ready and they have to have a working lab in order to treat the cells. I live on the pacific coast so I was already willing to fly to Pa, and flying to Tampa is no different for me. The problem is the whole lab thing. They don't know how long it will take to get their lab up and running and there isn't room right now to start me on the trial. Remember they have to have lab space to treat those darn cells. I am tempted to just fly out there to Pa and "visit" to introduce myself but I don't know if that would be seen as too pushy? I just don't know.

Re: how long is too long to wait for a trial?
 

Pat,
This trial is for Stages 0 and 1 who have had NO other treatment, ever. It is the only one I have found that is first line treatment rather than later stages.

Re: how long is too long to wait for a trial?
 

In Aug. '98 when my 4th stage invasive lobular carcinoma was discovered to have spread throughout my liver, I asked to be tested for HER2. I'd been reading about it. It was still in clinical trials. But there was talk that it was going to be fast tracked by the FDA out of trials and made available for metastatic patients.

They tested HER2 ONLY in Cali by UCLA, where Dr. Dennis Slamon was. They lost my tumor tissue. I called the onc's office numerous X and the hosp. I drove to the hosp and was directed to the Pathology Dept in the basement of North Shore Hosp on Long Island. I found a woman working there. She was aware of my situation and swore she would find that sample that day and take it to the Fed Ex office herself to send it to Cali. I was pushy, but desperate, and perfectly ladylike. She saw a person, I was not just a voice on the phone. She felt motivated. And she did as she promised and her sent her a beautiful card full of my gratitude. She had called me to assure me.

I lived in NY (mostly) and in Fla. I sent all my test results to my Fla onc. My fav onc. He called me at home. HAVE YOU STARTED CHEMO YET???
No. And I explained why. He said, in the last 2 wks the tumors throughout your liver have grown and are spreading even more. YOU MUST START CHEMO NOW.

Don't worry about HER2 and Herceptin! Start on the chemo. In 8 wks we'll test you again to make sure the Taxotere is working. YOU HAVE TO START CHEMO.

I knew this onc since 1995. He was NOT an alarmist. If he took the time to call me (unbidden) and speak in ALL CAPS with !!!!!!!!! I called right away.

Herceptin was made available on Sept 28, 1998. I began Herceptin, among the the first to avail themselves of the drug, in November of '98.

Are any of your oncs reporting to you what's going on with your tumor(s)??? They should be. Only 1 (my Fla onc) called me and sped me up and revved me up and motivated me to get on chemo.

So, in turn, that's what I'm doing with you VDC.

You know that's what cancer does, it keeps multiplying, growing, spreading with every hour of every day. You can't afford to do nothing. No one knows when you or anyone will be able to avail yourself of the immunotherapy trial. No one knows if it works on someone with active cancer. I have seen it fail with active cancer. In fact worsen the situation. In the interim of stopping all tx, the cancer grew and spread and couldn't be caught. It was out of control. I don't want that to happen to you or anyone else.

It seems now is not the time to worry about the trial but to start chemo!

I'm sorry, I don't mean to be pushy, or scare you. I am trying to save your life. And I couldn't live with myself if I didn't dare to speak up.

I hope you aren't offended or turned off. I am acting out of love for a Sister I don't even know. I've been around (20 yrs) to see similar situations (including my own). All the arrows are pointing to -- go start chemo!

Speak to your oncs. Get their opinions. Based on their readings of your reports. Why haven't they been urging you to do this?

With a hug,
Andi

Re: how long is too long to wait for a trial?
 

I appreciate the concern and the honesty! Really. That is exactly what I have been asking for from all of you. Just an honest appraisal.

This has been a fighting battle from the beginning. Since my cancer is "only" DCIS, (although grade 3 and necrotic to boot!) Mayo wouldn't even let me talk to a medical oncologist! (the chemo people) because chemo is not used with DCIS. It is surgery and radiation.....period. I had to fight (and I wasn't even ladylike in this case) to be allowed to speak with a medical oncologist. I was finally permitted to, but it was not without a lot of pushing and tears.

I do understand that DCIS does not compare at all to what all of you are facing and I would not even try to compare. But the thing that frustrates me the most is that this thing CAN and WILL become invasive if it hasn't already. The when and how isn't known by anyone. That is what I fear. No one knows.

Chemo isn't something they will even consider unless it goes invasive. BUT my likelihood of recurrence with current treatment protocol is somewhere over 25% and that is assuming they get it all and that everything is "clean."

Those aren't odds that I like all that well, particularly when I know that recurrence isn't likely to be a localized event.

So my choice is hard. Do I wait for a clinical trial which would greatly decrease my chances of recurrence? Or do I go ahead with surgery and radiation immediately in order to remove the risk of it turning invasive. How do you chose between those choices and how long is too long? None of my doctors seem to have any idea. None of them. Not the surgical oncologist, not the radiation oncologist and not the oncology doctor assigned to me. ....and the medical oncologist (chemo guy) pretty much laughed at me for even making an appointment to see him!

Let's just say that I'm frustrated with what is NOT known and none of my doctors are really all that helpful here.

Re: how long is too long to wait for a trial?
 

Just reading this tonight & I am reminded of my original treatment (or lack of it).
I was waiting to start a trial. Lost 10 weeks between op and start of chemo. I thought this was ok/normal & trusted the oncology team at my local hospital. It wasn't and I progressed.
Like you none of my Doctors seemed to know or be concerned, It took an Oncologist visiting from another hospital to move things on. He immediately arranged for scans and another more suitable trial. I was in new trial within a week.
I should have made a noise!!

Re: how long is too long to wait for a trial?
 

We all want docs to tell us not to worry. Of course. We don't want aggressive or worse abrasive docs. We want knowledgeable sensible docs. We need multiple opinions. We just do. Even the most brilliant sees you slightly differently than another brilliant doc. We are all different, docs included.

I have a friend who had DCIS. She had a lumpectomy (so I assume she saw an onc and of course a breast surgeon). She did radiation. She's had some scares over the yrs but remains good.

This is what we all want for you V.

But listen to Juls' experience. Learn. Listen to Flori -- been around for two decades fighting.

I'm glad to hear you wanted honest, cause that's what I am. Seems like Juls and Flori -- and you -- are having an honest discussion as well.

I happen to have heard of a lot of docs that told women on this board -- don't be silly, don't worry about it, I don't even know what you're doing here.

I had a surgeon (in 2013) tell me this. He threw me out of his office with a wave of the hand, not understanding why my onc sent me to him. The next day he went to the hosp and looked at CTs and had a nurse call me back to reschedule. He had conferred with 2 radiologists at the hosp and they had a plan.

In 2015 I returned to him, at the behest of my onc, cause my new thing (mesenteric mass) was spreading. The surg said, Well you can have the surg as your onc wants -- or you can do nothing. Wow, was I tempted to do nothing. But over lunch, I discussed the situation with my husb (who was inclined for us to do nothing too). I was thinking, if a friend asked me what to do -- I'd tell them to get a 2nd opinion.

And so, w/much effort, we located a 2nd opinion an hr away. He much to offer. He was concerned. Carcinoid tumor??? Oh dear. I wound up declining another surg to look at what proved benign in 2013. I asked for a CT guided needle biopsy (cause I'd had a CT guided needle biopsy of my liver in 1998). Oncological surgeon went and conferred w/the radiologist while we waited, with his 4 fellows following him and his assistant nurse. It's really deep, but it is doable. But I'd also like you to go for an ocreotide scan which will show definitively if we are dealing with a carcinoid tumor. Well -- look at that -- 2nd opinion came up with some interesting stuff. I did both. Passed that scan (2 hrs on 2 diff days after an injection) with flying colors. Not a carcinoid tumor. Definitively. And the CT needle biopsy (though an hr and a half of maybe 100 needles) determined the mass was benign.

Pays to get addl opinions.

Listen to Juls. Listen to Flori. Don't panic just follow up. Do what you'd advise a friend to do...

Wish I could find a nice succinct way of saying what I want, but I fail in that department hugely... Sorry.

Re: how long is too long to wait for a trial?
 

THANKS to all of you! I spent today lining up new mammograms and possibly MRI. Mammo for sure is set. My oncologist from Mayo said it should show any progression since my "variety of cancer" has a ton of calcification that show up under mammo conditions. Hopefully more calc's would indicate the rate of growth. At least my onc thought so. It is a place to start. Depending on the outcome of this, will determine which scan to do next. At least I have some action going! Finally. I should hear about the clinical trial by the end of January and it will probably take that long for all the new tests and scans. So they should coincide and at least I'll have some idea of what I am facing NOW. (instead of what I was facing in November) Thanks guys! Any other suggestions? I don't mind bluntness at all. I'm a pretty blunt gal myself. ;-) Any tests or scans that you would recommend? I am new to this and don't mind more information. I'm also a scientist by trade so I don't scare easily....and I research much!

Re: how long is too long to wait for a trial?
 

When you say surgery -- do you mean surgical biopsy?

How do they know DCIS? From looking at calcifications? On CT? On mammo?

Re: how long is too long to wait for a trial?
 

Andrea,
No I had two stereotactic biopsies. The first was local and diagnosed my calcifications as DCIS ER-, PR-, Grade 3 with necrosis.

After a "run in" with the local facility I flew to Rochester Minnesota Mayo Clinic and requested a second biopsy to confirm and run further tests. This stereotactic biopsy also said DCIS ER-, PR-, Grade 3 with necrosis, BUT it also added Her2 3+ and KI-67 20% Nice.....more "good"news.

The surgery I refer to is lumpectomy to be followed by radiation. Not a excisional biopsy. Of course the difference between the two is negligible. Mayo does a great job during their lumpectomies and the removed tissue is tested by the pathologist while you are still under anesthesia so that if the margins aren't clean they can remove more before closing you up! Sounded like a good plan to me.