Clinical trial for Pre menopausal Women who are ER+, PR+ to compare tamoxifen with ov

[astrid]

I am contemplating entering a clinical trial to compare ovarian function suppression (by triptorelin, oophorectomy, or ovarian irradiation) in combination with tamoxifen vs ovarian function suppression in combination with exemestane vs tamoxifen alone in patients with endocrine-responsive breast cancer in treating Premenopausal Women with Hormone-Responsive Breast Cancer.

I am 48 years old and still Premenopausal. I am ER+, PR+ and HER2+ (3.4). That combination is only about 15-20% of all breast cancers. The clinical trial does not specifically deal with the HER2+ aspect of my cancer. Susan Loves breast book says that tamoxifen is not very effective with HER2+ cancers, so I did some web research and have seen the following: The tumors most resistant to tamoxifen are those that contain not only estrogen receptors but also an overabundance of another growth factor receptor called HER2/neu and a molecule that activates the estrogen receptor called AIB1. Other studies suggest that some estrogen receptors may be located in the membrane, close to HER-2. “Tamoxifen binds to the estrogen receptor in those cells and instead of antagonizing it, it activates it. It acts like estrogen”.

I am scared to start tamoxifen alone because of what I read above and I am not aware of long term treatment for Premenopausal women other then tamoxifen. I am also scared of ovarian function suppression because my husband and I still have great sex and I do not want my drive to be decreased and this WILL happen. What do I do?? Go for the trial and leave the decision to fate or the lord? Do nothing and risk reoccurrence?? Do the standard treatment and risk a reoccurrence??

My sister died of BC at 40 and my grandmother died of BC at 53. I want live long then both of them. My sister died before they tested for HER2 and I would bet that both my sister and grandmother were ER+, PR+ and HER2+

[saleboat]

Hi Astrid--
I had the same tumor profile and have researched this subject to a good degree as well. I've been to three different Oncs, and they all recommend Tamox. I'm finally getting comfortable with it-- and I have the same quality of life concerns.

Here's a link to a thread that I started on my Tamox questions...there is an article that might interest you.

http://her2support.org/vbulletin/showthread.php?t=23729

You'll also find some good info/interviews on this site:
http://www.breastcancerupdate.com/

I hope this is helpful.

Jen

[Lori L]

Astrid

I wondered what your decision was on the clinical trial.

I am being given the option to participate in what sounds like the same trial and have the same concerns you expressed regarding tamoxifen and ovarian suppression. I just turned 40 yesterday, and I'm not sure I'm ready for how my body is going to function without ovaries and what other problems I could face if I go down that path.

I am HER-2/nue+ with FISH.

To further complicate things, I have had three pathologists review my tumor and come up with three different results (1 ER+/PR-, 2 ER-/PR- and 3 ER+/PR+).

I guess I'm also concerned about the exemestane arm of the trial, as I haven't yet done the research on what that is.

Any wisdom you have to offer would be appreciated. Thanks so much,

Lori L.

[astrid]

You have eight months to be eligible for the trial from the time you finish chemo. I see my ONC in 2 weeks and at that time, I will have my estrogen levels tested again. Right now I have not had a period since June and my estrogen levels show me in chemo pause. I am 48 years old, so I may really have been pushed in menopause. I am not eleigible for the trail unless I am truly pre menopausal. As, my estrogen levels are low, I am not worried about suppressing my ovaries. I am on tamoxifen and my breasts are smaller and far less dense so it seems to be doing it thing.



I want to tell you, that the lack of estrogen and the tamoxifen has NOT changed a great sex life. My husband and I just came back from vacation to celebrate our 20th wedding anniversary and we made love almost every day. We have NOT done that since we were in our 20s. Most have been the south pacific air and water???

[VirginiaGirl]

Just wanted to add my two cents regarding ovary suppression. I'm on herceptin 1x every 3 weeks & tamoxifen. Since I am ER+/PR+ it was strongly recommended that I shut down my ovaries through medicine or surgery. I was very afraid of messing w/ my hormones (refused tamoxifen after initial dx for that reason) and instant menopause (I'm 41) as I have struggled w/ hormonal mood swings in the past. I decided to have the oophorectomy since I didn't want to add medicinal side effects to the bag of stuff I might experience, and since I don't plan to have more children anyway. It's been a month and I'm happy to report I'm doing very well. Some mild hot flashes, but could be from tamoxifen, too. I had started an anti-depressant a few months ago to help me quit smoking (that was successful, yeah me!), stayed on it when I was dx with mets a week later (good reason to feel sad & depressed), and I really think that has helped a lot as well. Wellbutrin is my friend Good luck, and God bless!

[astrid]

I had my estrogen levels rechecked last week and on Tuesday I was randomized in the SOFT trial for hormone therapy. The SOFT trial is Suppression of Ovarian Function Trial (SOFT). The SOFT trial has three arms. One is Tamoxifen alone (which is the standard treatment used today for pre menopausal women and the treatment course I am currently on); the second is Tamoxifen plus ovarian suppression and the last is an experimental arm with a post menopausal drug called Exemestane plus ovarian suppression. The ovarian suppression can be done by surgery, radiation or a monthly shot of Triptorelin. For pre menopausal women with estrogen positive breast cancer, it is important to stop the estrogen. The estrogen in pre menopausal women is produced by the ovaries so shutting them down may be the right course of action. This trial is designed to test if the more aggressive approach will prevent reoccurrences and survival rates. The arm I was randomized to is Tamoxifen alone. I am not sure that is the best course of action, but I signed up for the clinical trial and some one has to be on that arm. I left it up the lords hands and this is the arm I received, so maybe I really don’t need to have my ovaries suppressed. I guess my concern is that Tamoxifen is supposed to shut down estrogen and when my levels were checked they were high. My level was 155. Since I am not getting a period it is hard to say what phase I am in. Normal Estrogen levels are:



Follic Phase (The first half of the menstrual cycle): 27-161
Periovulatory (Ovulation): +/-3 days: 187-382
Luteal Phase (The second half of the menstrual cycle): 33-201



This trial is a 5 year trial. I will have my estrogen levels checked periodically and I can drop from the study at any time if I want to be more aggressive with my treatment. Right now the quality of my life is very good on Tamoxifen alone and if I was one another arm of the trail, I may have to suffer unnecessary side effects.

[Lori L]

Thanks for the update Astrid. Its so helpful to hear the paths that others like me are taking.

For now, I think I have decided against the SOFT Trial because I am too much of a control freak to get comfortable with the randomization.

I am awaiting genetic testing results. Obviously, those results could make my decision for me.

In the meantime, other than recommending the SOFT Trial, the three oncologists I've seen have all recommended the Tamoxifen. I still have concern about the Tamoxifen resistence and cross-talk issues, but it seems like those issues are not as likely to arise while I'm on both Tamoxifen and Herceptin. That gives me until next summer to reevaluate and decide whether I want to continue on the Tamoxifen.

[Becky]

Dear Astrid


Tamoxifen does not suppress estrogen manufacture by the ovaries, adrenals or adipose tissue. Tamoxifen covers the estrogen receptor on the surface of breast/breast cancer cells so that estrogen cannot bind there. If estrogen does bind, it causes the excitation of the cell that leads to proliferation/reproduction.

This is why your estrogen levels are normal for a premenopausal/perimenopausal woman (because there is no ovarian suppression involved with Tamoxifen alone).

Kind regards

Becky