The Taylor-RX Trial Study
I am new so I probably posted this in the wrong area. I am sorry if I have. What I would like to know if there are others that are enrolled in The Taylor-RX Trial study. It is for patients with breast cancer that is estrogen receptor and/or progesterone receptor positive that has not spread to the axillary lymph nodes. It is for patients who doctors think they are candidates for both chemotherapy and hormone therapy to reduce risk of reoccurence. Even though 80 to 85 percent of patients with this stage of disease are expected to be alive in 10 years with hormonal therapy alone this study is attempting to identify those who benefit from chemotherapy and those that receive it unneccessarily. I am looking for others in this study. I signed up for it yesterday and I am having a lot of second thoughts. Would love to hear from others.
Comments
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My understanding of the Taylor RX trial was that it is designed to assess the benefits of chemo for women whose Oncotype DX score is in the intermediate risk group. My score was 24 which is right in the middle of that group.
I'm not in the study but am very interested in its methods and outcome. I have a neurologically based disability (since birth) and was advised against chemo by two doctors (breast surgeon and oncologist).
If you would care to share your feelings, why are you having second thoughts? Have you had the Oncotype DX test yet?
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Hi Carol: They sent my tissue samples to California today to determine my score. I signed up for the study yesterday. I am worried that if I am in the middle...the grey area of 11 to 25 that I will not be given the option for chemo. As I understand if you are in the middle of the 3 groups that a computer, more or less a coin toss, will decide if you take the hormone therapy alone or get the chemo and hormone therapy. I do not like not having control over the medication I will receive. I also am having trouble finding which phase this study is in. I read that in the earlier stages that side effects are worse than in studies that have been going on longer. At any rate I am probably just being overly worried. I am actually a nurse and like the idea of helping gain information about this horrid disease to help others however I also want to be with my family as long as possible. You might say I am torn at the moment. Our diagnosis is almost identical. Good luck to you and I will post when I find out my score. Thanks for your reply. --- Pam
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Pam,
Thanks for the clarification re: the "gray area". I was under the impression that they considered that area to be the entire intermediate risk range (18-30) but, clearly, that's not the case. It's interesting that the gray area extends down into the low risk range.
My husband suggested that I contact the Tailor-RX contact here in Las Vegas and volunteer myself as a data point even though I'm not in the study. I may still do that, at some point.
I couldn't take a chance on enrolling in the study and getting randomized to have chemo with my condition. It's too risky, from what my doctors told me. I'm therefore putting all my eggs in the "Arimidex basket", so to speak. We'll see how that turns out.
Yes, please do keep me posted when you find out your score.
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Carol I have decided that I am found to be in the grey area and chosen not to have chemo that I am going to drop out of the study which I can do at any time. I want to take the chemo unless I am in the bottom group and will pursue that avenue of treatment. I certainly understand you not wanting to do chemo however with the health considerations you have. Take care and God Bless.
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Pam, I too applied for the Taylor trial. Sent my Oncotype DX sample on 07/07/09 and still haven't received results. The trial is a partially randomized study which means that your onco can choose what treatment plan will apply to you and data will be used in the study. I particularly wanted to be sure that the participation did not reduce my treatment strategy. The only thing that would make my onco consider changed our treatment plan was if the Oncotype DX score was exceptionally low. However, even if it does come in low (below 11) I still have the option of continuing with the original treatment plan. Hope this info helps. If you have a different understanding from your onco, please let me know and I can reconfirm with my onco that my treatment will not be changed from the full charge chemo (4-4), rads, hormone therapy plan.
More info on this trial at: NCI's website www.cancer.gov
Love & Hugs,
DeniseM
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Pam
I was reading a bit more about the Tailorx study and see that the hormonal therapies used are based on menopausal status. My docs both told me that the 15% recurrence risk associated with my Oncotype score of 24 is cut in half for me (to 7.5%) because I'm taking an AI and not Tamoxifen. According to the Oncotype report I received, chemo would have brought my risk down to 6%, thereby buying me about 1.5% over an AI alone. Their reasoning was that this wasn't enough of a difference to risk the side effects of chemo, in my case. I agreed with their reasoning
These numbers are all approximate so it's difficult to assess the benefit or risk, IMO.
Good luck with your decision.
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Count me in on the TailorX Study. My sample was sent in on July 16th. My next app't with my ONC is July 30 and I will get my results then. I was under the impression that we could opt out at any time? Like everyone, I'm hoping that I my score is low...
Terri
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Terri (my560sel) - yes, you can opt out of the clinical trial at any time. Also hoping you receive good news at your July 30th appt!
Wishing you wellness,
DeniseM
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Yes i was told I could opt out however that is not what they encourage...at least the person I talked to didn't. They want people who will comply with the study and I understand that, however, if I get a high score and the computer choses me to not have chemo then I am dropping out and pursuing the chemo anyway. Hopefully I will get my score July 28, I am rather nervous abiout it.
CW i see you said you were taking AL insead of tamoxifen. What is AL? I am new to this and have a lot to learn. Just wondering if that is something I should consider. Hardly worth the chemo for 1.5 percent. I just know I want to do everything I can. Making all these decisions is so stressful. I had a lumpectomy May 29 and now I wish i would have had the mastectomy. I had a surgical biopsy in 2007 that showed pre cancer and two years later I was diagnosed with IDC. All this could drive you nuts worrying about if you made the right decision. Thanks to all of you who have walked this path before me for all your information and support.
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Pam,
I am taking an Aromatase Inhibitor (AI -- not AL
). Specifically, I'm taking Arimidex and will be taking it for at least five years. AI's are prescribed for post menopausal women.
http://arimidex.com/index.aspx
There are several other AI's, as I understand it - Femara and Aromasin. They are all in the same drug class but are manufactured by different companies.
What is your menopausal status? My understanding is that Tamoxifen is used for pre menopausal women.
The Oncotype DX report shows "average rate of distant recurrence in 10 years after five years of Tamoxifen [underlining is mine] treatment". It does not show statistics for AI's. As I said, both of my docs said the Tamoxifen numbers are cut in half for AI patients.
Hope this helps.
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Pam's Promise - not sure if I'm still in the study or just got randomized for the treatment I wanted or if the oncologist has more "say" in treatment than appears from the study information. Part of the study reads "Group 2 (Primary study group; ODRS 11-25): Patients are stratified according to..." and then lists tumor size, menopausal status, and then various planned treatment options, then Oncotype DX scores and ends with "Patients are then randomized to receive either hormonal therapy alone or combination chemotherapy and hormonal therapy."
I ended up with an Oncotype DX Recurrence Score of 11 which is the primary study group AND will be starting my Dose Dense chemotherapy next week Wed., July 29th @ 9am. It will be followed by hormonal therapy and radiation therapy. I am in the application for another trial, the CTSU Protocol E5103: A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab...". The TAILORx Study allows for concurrent enrollment in another CTSU study and perhaps because the second study does not have a hormonal therapy only arm it "forces" the TAILORx to place me into the "having chemotherapy" group.
Not entirely sure as it's getting a bit confusing with all the tests, procedures, doctors, and trail applications being done with me right now. Something to discuss with your doctor at any rate.
Love, Hugs, and Aloha from Hawaii,
DeniseM
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Carol: I am 55, post menopausal. I was fairly certain my doctor said I would take Tamoxifen for 5 years and then switch to Femara. However, I would not swear to anything at this point. My next appointment is Tuesday and I am hoping to get some of this cleared up. We are still waiting on the lumpectomy wound to close that had to be reopened and drained due to infection a month and a half ago. It is almost closed now however. I do have an appt with the doc in the Taylor study August 11. Hopefully my Onco score will be back and we can get on with this. My lumpectomy was May 29 and because of the infection I am behind in treatment. Carol I do appreciate you clearing this up for me. I have a lot of things going on right now. My mother has moderate Alzheimers and my dad is 91 and they are both still living on their own which is taking up a lot of my time. I am in the process of admitting my mother to a alzheimer's unit next week. I can't seem to focus on my health issues when I have theirs that are more pressing . I have not had a lot of time to research on my own my diagnosis and without this website I am sure I would be lost. Thanks again.
Thank you too Denise. Your post was very helpful also. You did get a good Onco score and I am thankful you did. I am certainly going to talk to my doc about this study as I would be interested in it also. I am just so afraid not to take the chemo if I am in the middle group and not chosen so this would be an option for me. In fact I am printing it out and taking it with me at my next appointment.
Thanks to all of you. I so much appreciate you both taking the time to write. What they say is true....God doesn't put more on you that you can handle, however, don't we all wish he didn't think we could handle so much.
Take care and hugs,
Pam
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Hi everyone!
Based on the string of messages, I question if they will ever recruit enough intermediate risk women willing to 'not do chemo'.
I did not get the oncotype test because my cancer was multi-focal -- one primary tumor at 1.5cm and two smaller tumors < . 4cm. I was told sending in one tumor sample would not be predictive of the others and I suppose sending all three would be too expensive. Despite this, being multi-focal and grade 3 likely puts me at intermediate risk anyway, and I would then want the chemo.
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Hi Pam,
You certainly have a "full plate" right now. I wish you the best in getting your parents' situation resolved. Just remember that your health counts too.
Please post back, or PM me, if you have any other questions. I'm no expert on breast cancer, by any stretch of the imagination, but I'm pretty good at researching things. I've been through my treatment (lumpectomy, Mammosite (accelerated) radiation and Arimidex daily for five years) so I guess that makes me a veteran of these wars
.
Best of luck,
Carol
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Just trying to keep this thread alive. I started my chemo August 18 and have had no side effects I am on CMF chemo. So far so good.
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Good to hear from you, Pam.
Glad that you don't have any side effects from the chemo. If I may ask, what is CMF chemo? How many treatments will you have?
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Carol CMF chemo is cytoxan, methotrexate and 5-FU. It only takes about 1 hour and 10 minutes to do and that includes the Aloxi they give me at the beginning for nausea and then the decadron. Both take 11 minutes a piece IV. After that I get 2 IV pushes.....methotrexate and 5-FU. After all of that they hang the Cytoxan and it takes 30 minutes to run. CMF is good for those with no positive lymph nodes. I was told I will not lose my hair and today is day 14 and I have not lost any. They said it may thin a small amount with each treatment which I will have a total of 6, one every three weeks. This is very doable. I have had no nausea, bad taste in my mouth or anything. There was a small mouth ulcer that came up inside my bottom lip on day 2 but I used Biotene mouthwash and toothpaste and 2 days later is was gone. It was hardly a bother however I didn't want to get anymore so I attacked it head on. I have been able to eat anything I want and not have any problems. I have rheuamtoid arthritis so the methotrexate given with the CMF has really helped with that. I hope you are doing well. Take care, Pam
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Hi everyone,
My results are in and I had good news. My score came back as 9 (7%) so I'm on Tamoxifen only. I started 11 days ago and so far so good. I don't really have any bad side effects so far other than a nagging headache and the other night I was dizzy, really dizzy....
I'm hoping that this Tamox is enough to get me through this and praying for all of you who are on chemo and rads that things go smoothly for you. We are all in this together, bonded by chance, friend by choice. Lets beat this thing into the ground forever!
Terri
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I agreed and then was second guessing myself while waiting for the results to come in, I guess it's the feeling of losing control. I would have had the Oncotype test anyway though. I was ecstatic when the score came back as a 6. I am still part of the study but in the "A" group, which I guess represents participants with a score <11.
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