Stef...aka Fauxma
So can you tell me a little bit about your experience with it...
Thanks..
~T
Comments
-
It is the Tailor X or Taylor
It is the Tailor X or Taylor X, can't remember which is the right spelling, study? I have only been in since the beginning of the year (maybe February). I had to wait to start rads until they got the results because if I had to have chemo that would have come before rads. As you know I am not doing the chemo. I am being treated at Kaiser and they have a large number of people in this study. So far, I saw my oncologist and then the clinical study person. I had a blood draw done by her. There were about 6 or 7 of those vials that they filled and they are sent to the trial. Not sure what for (I'm sure I was told but I didn't really care). It's their blood now. Oh, and I got pages and pages of information and a release that I signed before this happened. Basically it tells you about the study in general and giving blood etc. and being followed by your team and by the clinical study person (these can even be the same person) and that you can opt out anytime you want etc. You sign it and then they send all your information (diagnosis) and this in to the trial. If you are accepted (and I think that is a given because our oncologists knows the critia for the study) then you get randomized (think that took a couple of weeks or maybe just one) and then you give the blood. Then I started my rads. When they were done, I started on the arimidex. I just had my three month check up with my oncologist in June which was just a breast exam, bp, weight, temperature, blood tests to check stuff for the arimidex. I don't know when I will be giving blood again for the trial, they will let me know. I go for my mammo in September and for my next 3 month check up. I am also doing another study (not cancer related) for Kaiser. I got a kit in the mail to collect my saliva. I spent 5 minutes spitting into a little container, then sealed it with a solution and mailed it back. God knows what they needed the spit for. I also did blood tests for that. I honestly don't remember what the study is, but it seemed important at the time. You would think I had chemo brain. My mind is so much of a sieve. Let me know when you start and what goes on for you and if you are chemo or not. We can compare notes. I can't believe that we even had the same number. So far there isn't too much to the study. I think that they mostly receive the information from our oncologists about our check ups. These are the statistics that they are looking at. This goes on for 10 years and maybe longer. I think they look at recurrences, spread, new breast cancers, other cancers, if someone dies and what they died from and that will allow them to determine if chemo is useful for the people in the this gray area. Hope this helps. Gosh, I rambled.
Stef0 -
Thanks Stef... That isfauxma said:It is the Tailor X or Taylor
It is the Tailor X or Taylor X, can't remember which is the right spelling, study? I have only been in since the beginning of the year (maybe February). I had to wait to start rads until they got the results because if I had to have chemo that would have come before rads. As you know I am not doing the chemo. I am being treated at Kaiser and they have a large number of people in this study. So far, I saw my oncologist and then the clinical study person. I had a blood draw done by her. There were about 6 or 7 of those vials that they filled and they are sent to the trial. Not sure what for (I'm sure I was told but I didn't really care). It's their blood now. Oh, and I got pages and pages of information and a release that I signed before this happened. Basically it tells you about the study in general and giving blood etc. and being followed by your team and by the clinical study person (these can even be the same person) and that you can opt out anytime you want etc. You sign it and then they send all your information (diagnosis) and this in to the trial. If you are accepted (and I think that is a given because our oncologists knows the critia for the study) then you get randomized (think that took a couple of weeks or maybe just one) and then you give the blood. Then I started my rads. When they were done, I started on the arimidex. I just had my three month check up with my oncologist in June which was just a breast exam, bp, weight, temperature, blood tests to check stuff for the arimidex. I don't know when I will be giving blood again for the trial, they will let me know. I go for my mammo in September and for my next 3 month check up. I am also doing another study (not cancer related) for Kaiser. I got a kit in the mail to collect my saliva. I spent 5 minutes spitting into a little container, then sealed it with a solution and mailed it back. God knows what they needed the spit for. I also did blood tests for that. I honestly don't remember what the study is, but it seemed important at the time. You would think I had chemo brain. My mind is so much of a sieve. Let me know when you start and what goes on for you and if you are chemo or not. We can compare notes. I can't believe that we even had the same number. So far there isn't too much to the study. I think that they mostly receive the information from our oncologists about our check ups. These are the statistics that they are looking at. This goes on for 10 years and maybe longer. I think they look at recurrences, spread, new breast cancers, other cancers, if someone dies and what they died from and that will allow them to determine if chemo is useful for the people in the this gray area. Hope this helps. Gosh, I rambled.
Stef
Thanks Stef... That is exactly the information I was looking for... I can handle blood draws... Yes, I did notice our numbers were the same... I am just wondering if I will qualify for the study... I hope so... It just seems it would make the treatment decision easier...although I will do whatever my NEW onco recommends.... The only questionable are seems to be conflicting HER2 results.... one came back just over the positive mark... one came back just over the negative mark... and the third came back equivicable... (which is right in the middle)... I guess my doctor can interpret them better than I can....
Thank you again..
Hugs,
~T0 -
Yes you quality!taleena said:Thanks Stef... That is
Thanks Stef... That is exactly the information I was looking for... I can handle blood draws... Yes, I did notice our numbers were the same... I am just wondering if I will qualify for the study... I hope so... It just seems it would make the treatment decision easier...although I will do whatever my NEW onco recommends.... The only questionable are seems to be conflicting HER2 results.... one came back just over the positive mark... one came back just over the negative mark... and the third came back equivicable... (which is right in the middle)... I guess my doctor can interpret them better than I can....
Thank you again..
Hugs,
~T
Taleena, this is the study I originally was in but got booted once my score came back. It is a phase III trial and the numbers for the grey area are different for the trial then they are for Geromic labs. The grey area for the trial is between 11-25. The correct name of the trial is the TAILORx trial. Everything else Stef said is pretty much accurate.
Also, just wanted you to know....I have a two week repreve waiting on BRCA results, so that moves me 14 spaces on the board!! Evens out the playing field alittle bit more!! The soonest I could possibly start rads is the 27th!! This gives you time to catch up!
Pammy 0 -
Oh my dear friend Pammy...Akiss4me said:Yes you quality!
Taleena, this is the study I originally was in but got booted once my score came back. It is a phase III trial and the numbers for the grey area are different for the trial then they are for Geromic labs. The grey area for the trial is between 11-25. The correct name of the trial is the TAILORx trial. Everything else Stef said is pretty much accurate.
Also, just wanted you to know....I have a two week repreve waiting on BRCA results, so that moves me 14 spaces on the board!! Evens out the playing field alittle bit more!! The soonest I could possibly start rads is the 27th!! This gives you time to catch up! Pammy
Oh my dear friend Pammy... we really are in a game of "Shoots and Ladders" aren't we... well, I meet with my onco again on the 28th... so that puts me one space behind you... (however I get extra spaces back points because I don't have those stylish tatoos..)lol.. Yes.. I think I will qualify for the trial.. the only question is going to be on the HER2 status... can you believe 3 different tests.... 3 different results... I can only say that Murphy's Law couldn't be any closer in my book... I fall into it every darned time...lol 1st test shows +.... 2nd test shows -.... and 3rd shows equivatable... (which is right in the middle) once again... the only ones that can take part in the trial, I believe are, HER2 negative... I guess I will leave it up to Dr. Kaun to decide.
Well... I guess my roll is over... your turn!
Hugs to you my friend.
~T0 -
Now I know why my numberstaleena said:Oh my dear friend Pammy...
Oh my dear friend Pammy... we really are in a game of "Shoots and Ladders" aren't we... well, I meet with my onco again on the 28th... so that puts me one space behind you... (however I get extra spaces back points because I don't have those stylish tatoos..)lol.. Yes.. I think I will qualify for the trial.. the only question is going to be on the HER2 status... can you believe 3 different tests.... 3 different results... I can only say that Murphy's Law couldn't be any closer in my book... I fall into it every darned time...lol 1st test shows +.... 2nd test shows -.... and 3rd shows equivatable... (which is right in the middle) once again... the only ones that can take part in the trial, I believe are, HER2 negative... I guess I will leave it up to Dr. Kaun to decide.
Well... I guess my roll is over... your turn!
Hugs to you my friend.
~T
Now I know why my numbers were in the middle. Murphy's Law. I will give you one guess what my last name is. Murphy.
Stef0 -
Oh my Stef... well then ..fauxma said:Now I know why my numbers
Now I know why my numbers were in the middle. Murphy's Law. I will give you one guess what my last name is. Murphy.
Stef
Oh my Stef... well then .. yes, I guess Murphys law would definately apply to you...
LOL..
~T0 -
Everything you ever wanted to know about Tailor X
Looked it up and thought I would post it.
TAILOR X ECOG-PACCT's Phase III Trial: Personalizing Adjuvant Breast Cancer Treatment
The National Breast Cancer Coalition Fund (NBCCF) is partnering with the Eastern Cooperative Oncology Group (ECOG) and the National Cancer Institute (NCI) on a clinical trial in order to determine whether certain women with early stage breast cancer can forego chemotherapy without having to worry about their breast cancer recurring. Currently, most women with early-stage breast cancer are advised to receive chemotherapy in addition to radiation and hormonal therapy, even though research has not demonstrated that chemotherapy benefits all of them equally.
The trial, known as TAILORx (Trial for Assigning IndividuaLized Options for Treatment (Rx)), will use a laboratory test (Oncotype DX™) to determine the best individual therapy for women with early stage, node-negative, and estrogen receptor-positive breast cancer. The results from this study will allow women and clinicians to make more objective and informed decisions about adjuvant treatment, helping target therapies to those women more likely to benefit from them and sparing women unlikely to benefit.
The TAILORx trial will enroll over 10,000 patients from 900 clinical sites in the United States and Canada.
What is the Oncotype DX™ test?
Oncotype DX™ is a laboratory test that can be used on preserved (formalin-fixed, paraffin-embedded) Stage I or II, hormone receptor-positive breast cancer tumor specimens from women whose tumors have not spread to their axillary lymph nodes. Oncotype DX™ measures the level of activity (or "expression") of 21 specific genes within a tumor in order to determine how aggressive the tumor is as well as how likely a patient is to respond to certain treatments. Based on those measurements, a "Recurrence Score" (RS) is assigned to the individual tumor.
For more information on the Oncotype DX™ test, see NBCCF's fact sheet "Prediction of Recurrence Using the Oncotype DX™ Test."
How is the TAILORx Trial Designed?
This is a multicenter, partially randomized study. Patients are assigned to one of three treatment groups based on their risk of recurrence as determined by the Oncotype DX™ test. Group 2 will include women at intermediate risk of recurrence and is the primary group being studied in this trial. Groups 1 and 3 are considered to be secondary study groups.
Group 1 (Oncotype DX recurrence score < 11: Includes patients considered at low risk of recurrence. Women will receive standard hormonal therapy (e.g., tamoxifen or an aromatase inhibitor [e.g., anastrozole, letrozole, or exemestane], or tamoxifen followed by an aromatase inhibitor) at the discretion of the treating physician for 5 or 10 years.
Group 2 (Oncotype DX recurrence score 11 - 25) Includes patients considered at intermediate risk of recurrence. Women will be divided based on their tumor size, menopausal status, planned chemotherapy, and planned radiation therapy. Patients are then randomized to receive either hormonal therapy alone or chemotherapy plus hormonal therapy:
Arm I (Experimental): Women will receive hormonal therapy, as in Group 1.
Arm II (Standard): Women will receive chemotherapy followed by hormonal therapy, as in Group 3.
Group 3 Oncotype DX recurrence score > 25): Includes patients considered at high risk of recurrence. Women will receive chemotherapy followed by hormonal therapy.
All women will be followed periodically for up to 20 years following completion of treatment.
The primary endpoint1 of this study is to compare disease free survival and overall survival among women at intermediate risk of breast cancer recurrence who were treated either with hormonal therapy alone or chemotherapy plus hormonal therapy (Group 2).
The secondary endpoints include evidence on whether adjuvant hormonal therapy alone is sufficient treatment for patients at low risk of breast cancer recurrence (Group 1), as well as data on the disease free survival and overall survival rates for this group.
Who is Eligible for the TAILORx Trial?
This trial is for women who have been recently diagnosed with early-stage breast cancer. A woman must meet all of the following characteristics to be eligible for this study:
Age: 18 - 75 years
Disease Characteristics:
Estrogen and/or Progesterone Receptor Positive
Her2/neu Negative by either fluorescent in situ hybridization (FISH) or immunohistochemistry (IHC) (e.g., 0 or 1+ by DAKO HercepTest)
Surgery:
Either a modified radical mastectomy or a lumpectomy, plus an acceptable axillary procedure (i.e., sentinel lymph node biopsy and/or axillary dissection) within the past 84 days
Must have adequate tumor-free margins for invasive and ductal carcinoma in situ
Lobular carcinoma in situ involving the resection margins is allowed
Negative axillary nodes as determined by a sentinel lymph node biopsy and/or axillary dissection
Tumor size 1.1-5.0 cm
Tumors that measure 5 mm-1.0 cm are allowed if characteristics are associated with a high risk of relapse
If microscopic measurement is used and tumor includes ductal carcinoma in situ, the measurement should include only the invasive component of the tumor
Breast Cancer Specimen:
Tissue specimen from the primary tumor must be available for diagnostic testing with Oncotype DX to determine Oncotype Recurrence Score
No prior Oncotype DX Assay unless patient has a recurrence score of 11-25
Prior/Concurrent Therapy:
Patients who developed breast cancer while receiving a selective estrogen-receptor modulator (SERM) (e.g., tamoxifen, toremifene, or raloxifene) or an aromatase inhibitor (e.g., anastrozole, letrozole, or exemestane) for breast cancer prevention, or a SERM for other indications (e.g., raloxifene for osteoporosis), are INELIGIBLE
Prior SERM or aromatase inhibitor therapy that was administered for up to 8 weeks for this cancer is allowed
No prior chemotherapy or radiation therapy for breast cancer
No concurrent radiation therapy with chemotherapy
Previous Breast Cancer Diagnosis:
No prior ipsilateral or contralateral invasive breast cancer, bilateral synchronous cancers, or prior ipsilateral or contralateral ductal carcinoma in situ are allowed
How is NBCCF involved?
NBCCF is involved in many aspects of the design and implementation of the TAILORx trial. Representatives of NBCCF are serving on the Steering Committee and Data Monitoring Committee; attending and participating in the investigator meetings; and are helping to accrue patients for the trial.
For more information about the TAILORx trial, including clinical site locations, visit NCI's website or ClinicalTrials.gov.
Footnote
1 National Breast Cancer Coalition Fund. Outcomes in breast cancer clinical trials. Fact sheet, October 2004.0 -
Thank you...phoenixrising said:Everything you ever wanted to know about Tailor X
Looked it up and thought I would post it.
TAILOR X ECOG-PACCT's Phase III Trial: Personalizing Adjuvant Breast Cancer Treatment
The National Breast Cancer Coalition Fund (NBCCF) is partnering with the Eastern Cooperative Oncology Group (ECOG) and the National Cancer Institute (NCI) on a clinical trial in order to determine whether certain women with early stage breast cancer can forego chemotherapy without having to worry about their breast cancer recurring. Currently, most women with early-stage breast cancer are advised to receive chemotherapy in addition to radiation and hormonal therapy, even though research has not demonstrated that chemotherapy benefits all of them equally.
The trial, known as TAILORx (Trial for Assigning IndividuaLized Options for Treatment (Rx)), will use a laboratory test (Oncotype DX™) to determine the best individual therapy for women with early stage, node-negative, and estrogen receptor-positive breast cancer. The results from this study will allow women and clinicians to make more objective and informed decisions about adjuvant treatment, helping target therapies to those women more likely to benefit from them and sparing women unlikely to benefit.
The TAILORx trial will enroll over 10,000 patients from 900 clinical sites in the United States and Canada.
What is the Oncotype DX™ test?
Oncotype DX™ is a laboratory test that can be used on preserved (formalin-fixed, paraffin-embedded) Stage I or II, hormone receptor-positive breast cancer tumor specimens from women whose tumors have not spread to their axillary lymph nodes. Oncotype DX™ measures the level of activity (or "expression") of 21 specific genes within a tumor in order to determine how aggressive the tumor is as well as how likely a patient is to respond to certain treatments. Based on those measurements, a "Recurrence Score" (RS) is assigned to the individual tumor.
For more information on the Oncotype DX™ test, see NBCCF's fact sheet "Prediction of Recurrence Using the Oncotype DX™ Test."
How is the TAILORx Trial Designed?
This is a multicenter, partially randomized study. Patients are assigned to one of three treatment groups based on their risk of recurrence as determined by the Oncotype DX™ test. Group 2 will include women at intermediate risk of recurrence and is the primary group being studied in this trial. Groups 1 and 3 are considered to be secondary study groups.
Group 1 (Oncotype DX recurrence score < 11: Includes patients considered at low risk of recurrence. Women will receive standard hormonal therapy (e.g., tamoxifen or an aromatase inhibitor [e.g., anastrozole, letrozole, or exemestane], or tamoxifen followed by an aromatase inhibitor) at the discretion of the treating physician for 5 or 10 years.
Group 2 (Oncotype DX recurrence score 11 - 25) Includes patients considered at intermediate risk of recurrence. Women will be divided based on their tumor size, menopausal status, planned chemotherapy, and planned radiation therapy. Patients are then randomized to receive either hormonal therapy alone or chemotherapy plus hormonal therapy:
Arm I (Experimental): Women will receive hormonal therapy, as in Group 1.
Arm II (Standard): Women will receive chemotherapy followed by hormonal therapy, as in Group 3.
Group 3 Oncotype DX recurrence score > 25): Includes patients considered at high risk of recurrence. Women will receive chemotherapy followed by hormonal therapy.
All women will be followed periodically for up to 20 years following completion of treatment.
The primary endpoint1 of this study is to compare disease free survival and overall survival among women at intermediate risk of breast cancer recurrence who were treated either with hormonal therapy alone or chemotherapy plus hormonal therapy (Group 2).
The secondary endpoints include evidence on whether adjuvant hormonal therapy alone is sufficient treatment for patients at low risk of breast cancer recurrence (Group 1), as well as data on the disease free survival and overall survival rates for this group.
Who is Eligible for the TAILORx Trial?
This trial is for women who have been recently diagnosed with early-stage breast cancer. A woman must meet all of the following characteristics to be eligible for this study:
Age: 18 - 75 years
Disease Characteristics:
Estrogen and/or Progesterone Receptor Positive
Her2/neu Negative by either fluorescent in situ hybridization (FISH) or immunohistochemistry (IHC) (e.g., 0 or 1+ by DAKO HercepTest)
Surgery:
Either a modified radical mastectomy or a lumpectomy, plus an acceptable axillary procedure (i.e., sentinel lymph node biopsy and/or axillary dissection) within the past 84 days
Must have adequate tumor-free margins for invasive and ductal carcinoma in situ
Lobular carcinoma in situ involving the resection margins is allowed
Negative axillary nodes as determined by a sentinel lymph node biopsy and/or axillary dissection
Tumor size 1.1-5.0 cm
Tumors that measure 5 mm-1.0 cm are allowed if characteristics are associated with a high risk of relapse
If microscopic measurement is used and tumor includes ductal carcinoma in situ, the measurement should include only the invasive component of the tumor
Breast Cancer Specimen:
Tissue specimen from the primary tumor must be available for diagnostic testing with Oncotype DX to determine Oncotype Recurrence Score
No prior Oncotype DX Assay unless patient has a recurrence score of 11-25
Prior/Concurrent Therapy:
Patients who developed breast cancer while receiving a selective estrogen-receptor modulator (SERM) (e.g., tamoxifen, toremifene, or raloxifene) or an aromatase inhibitor (e.g., anastrozole, letrozole, or exemestane) for breast cancer prevention, or a SERM for other indications (e.g., raloxifene for osteoporosis), are INELIGIBLE
Prior SERM or aromatase inhibitor therapy that was administered for up to 8 weeks for this cancer is allowed
No prior chemotherapy or radiation therapy for breast cancer
No concurrent radiation therapy with chemotherapy
Previous Breast Cancer Diagnosis:
No prior ipsilateral or contralateral invasive breast cancer, bilateral synchronous cancers, or prior ipsilateral or contralateral ductal carcinoma in situ are allowed
How is NBCCF involved?
NBCCF is involved in many aspects of the design and implementation of the TAILORx trial. Representatives of NBCCF are serving on the Steering Committee and Data Monitoring Committee; attending and participating in the investigator meetings; and are helping to accrue patients for the trial.
For more information about the TAILORx trial, including clinical site locations, visit NCI's website or ClinicalTrials.gov.
Footnote
1 National Breast Cancer Coalition Fund. Outcomes in breast cancer clinical trials. Fact sheet, October 2004.
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