HER2 Clinical Trial - Indiana University

I'm on this clinical trial and will find out at some point soon what group I am to be in. There are three - one that gets 4 A/C and 12 Taxol and follow up only; one that gets 4 A/C, 12 Taxol with Herceptin and follow up; one that gets 4 A/C, 12 Taxol followed by a year of Herceptin. I am concerned about the Taxol. If I were not on the clinical trial, I would be getting the 4 A/C and 6.5 weeks of daily radiation. I have had 2 A/C treatments and have been lucky enough to have tiredness as my only side effect. I will also get the radiation on the trial. Do all of you think this clinical trial sounds like it is worth it? My cancer was 2 cms, ER/PR negative, HER2 positive, no node involvement. I am 66 years old and wonder if the trial is worth it for someone like me. My daughter thinks it is overkill. I really think the opinions of other cancer patients are the ones that count.

Hi Kalford3:

Your diagnosis is very similar to what mine was. (1.7 cm tumour, no nodes, HER2 +) As a treatment I received 4 A/C plus 4 taxol treatments last year. On this trial you are receiving 3 times the regular taxol treatments (unless the protocol has changed very recently). I found the A/C treatments not too bad to take - same as you - mostly tiredness. The taxol treatments caused physical pain in my lower joints somewhat like arthritis as well as numbness and I nearly lost my fingernails. I think that on longer taxol treatment from what I have read on this board that fingernail loss is a real possibility.

As a note: you have described one of your trial arms twice: "4 A/C, 12 Taxol followed by a year of Herceptin" so you should add to your post to describe what the third option is.

My opinion: If you are in good physical shape, I would try to go through with the treatments. I understand that herceptin and taxol together have "synergy" so that you will likely get far superior results than just herceptin or taxol separately. It is possible that the taxol dose that you are getting is less than normal which is why they are giving so many doses to you and therefore it would be physically easier to take. I would check that possibility.

At 60, you have a statistical probability of living into your 80's which is at least 20 years more if you lick this. Although it is horrible going through chemo, it is only a tiny fraction of time compared to all those potential years. If you don't have over-riding health concerns in addition to cancer I would encourage you to brave the trial.

Trials are cutting-edge and particularly phase 3 trials have hopeful stats to back them up from the phase 1 & 2 parts that indicate superior survival chances to conventional treatment. The other thing to consider... your doctor wouldn't have suggested this trial if s/he didn't think you could do it.

Regards,
Merridith

I think it is a very good idea to go full steam ahead, go at it with all you got and participate! I am doing a trial at the same hospital.

It's a hard decision to make. You have to understand, there are no guarantees either way. It is *possible* that the surgery and radiation would be enough w/o any chemo at all. Then, of course, your daughter would be right. It is also possible that w/ a tumor that size, some cells escaped and are settled in somewhere to make an appearance sometime in the future. That does happen, even w/o positive nodes.

In my own case, I wouldn't have had chemo at all if I had my way. My daughters bullied me into it. I was convinced I was as good as gone already. I had a 2 cm tumor, 7/11 nodes+, ErPr-, Her2+ in '99; had AC x 4 and Taxotere x 4 followed by radiation, and am, so far, (knock wood) NED. From a recent study, it looks as if the 5 year survival on this regimen is better than the previous treatments. The proposed Indiana study may be able to show if the addition of Herceptin makes a significant difference. I don't know how much your age has to do with it. I've noticed that the older I get, the younger the older people seem to be...<g>, and I really think that nowadays one doesn't get 'elderly' until older than 85 or so. Up 'til recently, docs didn't treat older women aggressively, (one theory is that cancer in older women tends to grow more slowly but I'm not sure if that holds for ErPr- people; another theory is that 'old' people couldn't tolerate the treatment, but recent studies have shown that to be NOT true). The Taxotere (only slightly different from Taxol) wasn't the most pleasant thing in the world, but survivable. I have to say, I am very glad I listened to my daughters: I've consciously enjoyed my life since then.

An article by Donald Gleason in 1992 says:
"There are now reliable data about cure rates for breast cancer from mastectomy (surgical removal of the breast). Half of all women who are treated with mastectomy [or w/ the lumpectomy + radiation option] will be completely cured by the operation alone. The odds go up to about 80% if the cancer hasn't spread beyond the breast. If the cancer has spread(metastasized) beyond the breast, the cure rate drops to about 30%. The presence of metastasis to the lymph nodes is not --repeat, is not-- a death sentence. Three out of ten women with metastasis to the lymph nodes will be completely cured by surgery alone. These odds may be improved with chemotherapy.

"The most difficult thing for patients and therapists to accept is the fact that a small percentage of breast cancers will have spread beyond the breast and lymph nodes by the time that they are detected. These are usually incurable. Chemotherapy and radiation can give some women some extra years, but will rarely cure. About 20% or so of breast cancers don't metastasize readily and are curable by surgery even if the cancer is large when removed. The majority of cancers are curable if caught early and incurable if caught late. The problem is that it is impossible to tell which tumors will metastasize and which ones won't until they do it."

That article is over ten years old and the numbers have improved a tiny bit but that's about it. Over a hundred years ago Halstead invented the radical mastectomy, and his 5 year survival rates were said to have been about 50%. So, there has been some improvement overall. But there's still no way to tell if you or I or anyone on this forum is going to survive the beast. Researchers are working, and progress is being made, slowly. Being in the trial would be a way of possibly helping other women down the line, which is something to be very proud of. None of us can tell you if it actually will help you, though.

I have to say, I am not sure that anyone should ever use the word 'cure' in regard to BC. I have known women who truly believed they were cured, only to find the beast gnawing at them again even 15 or 20 yrs later, so I disagree w/ the author I quoted about that. The women I know who have had BC (and I now know more women who've had that diagnosis than 'healthy' women) say "the only way I'll know I'm cured is when I die
of something else". May we all live long enough to die of something else!!

Please excuse the length of this post--I do tend to be wordy, and apologize for that. Whatever your decision, let us know. We'll all be rooting for you--either way!

JoAnn

Thank you all for your comments. They have been the best advice I have had so far. I think I will continue with the trial, if nothing else it might help someone else (like JoAnn said). Anyway, I will keep you updated. And, I appreciate your advice very much.