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11-04-2009, 03:11 PM
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#21
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Senior Member
Join Date: Oct 2007
Posts: 1,851
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Re: Neratinib Trial 09
Mary Anne,
Great news that you're in the trial.
Joan
__________________
Diagnosed stage 2b in July 2003 (2.3 cm, HER2+, ER-/PR-, 7+ nodes). Treated with mastectomy (with immediate DIEP flap reconstruction), AC + T/Herceptin (off label). Cancer advanced to lung in Jan. 2007 (1 cm nodule). Started Herceptin every 3 weeks. Lung wedge resection April 2007. Cancer recurred in lung April 2008. RFA of lung in August 2008. 2nd annual brain MRI in Oct. 2008 discovered 2.6 cm cystic tumor in left frontal lobe. Craniotomy Oct. 2008 (ER-/PR-/HER2-) followed by targeted radiation (IMRT). Coughing up blood Feb. 2009. Thoractomy July 2009 to cut out fungal ball of common soil fungus (aspergillus) that grew in the RFA cavity (most likely inhaled while gardening). No cancer, only fungus. Removal of tiny melanoma from upper left arm, plus sentinel lymph node biopsy in Feb. 2016. Guardant Health liquid biopsy in Feb. 2016 showed mutations in 4 subtypes of TP53. Repeat of Guardant Health biopsy in Jana. 2021 showed 3 TP53 mutations, BRCA1 mutation and CHEK2 mutation. Invitae genetic testing showed negative for all of these. Living with MBC since 2007. Stopped Herceptin Hylecta (injection) treatment in March 2020. Recent 2021 annual CT of chest, abdomen and pelvis and annual brain MRI showed NED. Praying for NED forever!!
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11-04-2009, 04:11 PM
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#22
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Senior Member
Join Date: Jun 2006
Location: San Antonio, TX
Posts: 2,357
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Re: Neratinib Trial 09
Thank you Joan! So far no Side Effects. Maybe I got the ol' Placebo! ma
__________________
MA in TX.
Grateful for each and every day....
Diag. 12/05 at age 60
Stage II, Grade 3, 4.5 cm primary tumor
ER/PR- Her2 +3 strongly positive
Her2 by FISH 7.7 amplified
vascular invasion
Ki67 20% borderline
Jan - March '06 Taxotere/Adriamycin X 3 to try to shrink tumor - it grew
April '06 Rt Modified Radical Mas, 7 of 9 nodes positive
April - Aug. '06 Herceptin/Taxol/Carboplatin X 8 (dose dense)
Sept - Dec. '06 Navelbine/Herceptin x 8 (dose dense)
Radiation & Herceptin Jan. 22 - March 1, 2007
Finished Herceptin Dec. 10 '08! One extra year.
Port removed August, 2012.
8 1/2 years since diagnosis! 5 1/2 Years NED!
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11-06-2009, 09:26 AM
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#23
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Member
Join Date: Jun 2009
Posts: 7
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Re: Neratinib Trial 09
In response to Laurel's recent post and Rich's comments, wouldn't Zometa every 6 months be standard of care anyway, especially if you are receiving an AI? Not sure how they can prohibit this in the Neratinib study. I am on the SWOG307 study but if I had not gone on this, I would have been taking Zometa every 6 months anyway. The SWOG307 study is looking at higher doses of bisphosphonates in early stage disease to see if there is a survival benefit. There is an afternoon of bisphosphonate discussion planned for the San Antonio conference so I'm interested in any results that are presented. Neratinib may be a hot topic, too, so it should be an interesting conference. Will anyone be live blogging from the conference?
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11-06-2009, 10:06 AM
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#24
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Senior Member
Join Date: May 2008
Location: Hershey, PA. Live The Sweet Life!
Posts: 2,005
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Re: Neratinib Trial 09
The folks administering the Neratinib trial will allow bisphosphonates outside of the SWOG trial in cases of "documented" osteopenia or osteoporosis. No one may remain in SWOG and participate in the Neratinib trial. If you have a bone density test result that supports the diagnosis of osteopenia/porosis you may continue the bisphosphonate prescribed by your M.D., and even began receiving one for the condition. They are insisting you begin your bisphosphonate treatment for the documented osteopenia/porosis 2 weeks prior to beginning the Neratinib trial. I have not been able to secure a method around this restriction, so I will not participate in this trial and will remain in SWOG. I did have a bone density this week which in the words of my trial nurse at Hershey who reviewed the scans, "your bones are so tough nothing is going to break them!"
If I wish to pursue the Neratinib trial I must discontinue the Clondronate, wash out, and begin the trial. If after several months on an A.I. without a bisphosphonate I develop osteopenia, I would be permitted a bisphosphonate to treat the condition, at least that is my understanding, but I'd verify this if you are on an A.I. or are menopausal. To answer your question whether it is protocol to prescribe a bisphosphanate in conjunction with an A.I. in the absence of documented osteopenia, it is not. You can talk your Onc. into giving it to you "off label" which leaves you at the mercy of your insurance carrier to approve payment or not. Capital Blue Cross would approve Fosamax under these conditions for me.
I suggest you call a center where they are running this trial and begin a dialog and let me know if you are encountering the same restrictions.
__________________
Smile On!
Laurel
Dx'd w/multifocal DCIS/IDS 3/08
7mm invasive component
Partial mast. 5/08
Stage 1b, ER 80%, PR 90%, HER-2 6.9 on FISH
0/5 nodes
4 AC, 4 TH finished 9/08
Herceptin every 3 weeks. Finished 7/09
Tamoxifen 10/08. Switched to Femara 8/09
Bilat SPM w/reconstruction 10/08
Clinical Trial w/Clondronate 12/08
Stopped Clondronate--too hard on my gizzard!
Switched back to Tamoxifen due to tendon pain from Femara
15 Years NED
I think I just might hang around awhile....
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11-16-2009, 01:29 PM
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#25
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Member
Join Date: Nov 2009
Posts: 11
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Re: Neratinib Trial 09
Hello Everyone,
I am new to the boards and am in the neratinib trial- I started Oct 7. We are pretty sure I am getting the real drug because I am dealing with severe side effects- but we are working on managing them and I continue on.
Diagnosed 3/18/08
Mastectomy, TCH -6 rounds
Herceptin 1 year
Radiation - 33 rounds
Neratinib- current
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11-16-2009, 02:27 PM
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#26
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Senior Member
Join Date: Jun 2006
Location: San Antonio, TX
Posts: 2,357
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Re: Neratinib Trial 09
KristyAnn, sorry you are having bad side effects, but so glad you got in the trial. Will you let us know what you do to help with the symptoms?
Oh, yes, where are you doing the trial?
ma
__________________
MA in TX.
Grateful for each and every day....
Diag. 12/05 at age 60
Stage II, Grade 3, 4.5 cm primary tumor
ER/PR- Her2 +3 strongly positive
Her2 by FISH 7.7 amplified
vascular invasion
Ki67 20% borderline
Jan - March '06 Taxotere/Adriamycin X 3 to try to shrink tumor - it grew
April '06 Rt Modified Radical Mas, 7 of 9 nodes positive
April - Aug. '06 Herceptin/Taxol/Carboplatin X 8 (dose dense)
Sept - Dec. '06 Navelbine/Herceptin x 8 (dose dense)
Radiation & Herceptin Jan. 22 - March 1, 2007
Finished Herceptin Dec. 10 '08! One extra year.
Port removed August, 2012.
8 1/2 years since diagnosis! 5 1/2 Years NED!
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11-18-2009, 01:12 PM
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#27
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Member
Join Date: Nov 2009
Posts: 11
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Re: Neratinib Trial 09
Hi Mary Anne,
I am in the trial at the Tyler Cancer Center in Tyler, Texas- my onc is very active and last time I saw her, she told me she had the most patients in the trial at that time- she is VERY excited about neratinib.
Currently I take immodium often and on a schedule to try to manage the side effects- I am on where near controlling them. I also eat a diet high in potassium and magnesium since I ended up on IV potassium after the first month on neratinib. Hopefully things will settle down a bit- another online friend in the Stage 3 trial said it took her side effects about 2 months to become manageable.
Kristy
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11-20-2009, 12:58 PM
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#28
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Senior Member
Join Date: Sep 2008
Location: Eugene, Oregon
Posts: 347
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Re: Neratinib Trial 09
Hi all,
I pulled this thread up because I just found out I might be able to take part in this trial. Any more info on your side effects or possible risks?
Celeste
__________________
"Dancers Against Cancer" in the Eugene, OR Komen Race for the Cure 2010
Diagnosed 8/7/08 with stage 3 invasive ductal carcinoma, micropapillary pattern, Her2 3+, ER+,PR-, grade II, positive lymph nodes.
Received 6doses of Taxotere, Carboplatin with Herceptin continuing for a year...DONE.
1/28/09 Left Modified Radical Mastectomy, Right Simple Mastectomy.
Surgery pathology: No invasive carcinoma present and 17 lymph nodes removed all negative! Only small amount of carcinoma in situ in left breast.
March/April '09, Radiation to left chest wall.
Currently involved in Neratinib clinical trial.
"Well being I won
and wisdom too,
I grew and joyed in my growth;
from a word to a word
I was led to a word
from a deed to another deed." (Odin)
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11-23-2009, 11:42 AM
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#29
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Member
Join Date: Nov 2009
Posts: 11
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Re: Neratinib Trial 09
The most common side effect is diarrhea- in my case severe diarrhea but I dont think my severity is all that common. Ive been on since Oct 7 and am just now getting the diarrhea under management- I am also taking potassium supplements as the constant side effects were leaving me severely depleted.
Another patient in the same center where I go, has loose stools around 3 a day- so she has the side effect but she is on the really mild side.
Kristy
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11-26-2009, 01:47 PM
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#30
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Senior Member
Join Date: Jun 2006
Location: San Antonio, TX
Posts: 2,357
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Re: Neratinib Trial 09
Good News with some not so good news!
I got put out of the neratinib trial because they couldn't get a good EKG. They did about 6 on Nov. 2 and about 4 more yesterday. They had the same trouble before my surgery but didn't think it was real. They thought I was just to stressed then....well, I was!
Anyway, I'm sad to be out, but incredibly glad they saw the problem. I go to the cardiologist on Dec. 7! I seem to have "electrical" problems!
Next!
Happy Turkey Day to all, ma
__________________
MA in TX.
Grateful for each and every day....
Diag. 12/05 at age 60
Stage II, Grade 3, 4.5 cm primary tumor
ER/PR- Her2 +3 strongly positive
Her2 by FISH 7.7 amplified
vascular invasion
Ki67 20% borderline
Jan - March '06 Taxotere/Adriamycin X 3 to try to shrink tumor - it grew
April '06 Rt Modified Radical Mas, 7 of 9 nodes positive
April - Aug. '06 Herceptin/Taxol/Carboplatin X 8 (dose dense)
Sept - Dec. '06 Navelbine/Herceptin x 8 (dose dense)
Radiation & Herceptin Jan. 22 - March 1, 2007
Finished Herceptin Dec. 10 '08! One extra year.
Port removed August, 2012.
8 1/2 years since diagnosis! 5 1/2 Years NED!
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11-26-2009, 02:21 PM
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#31
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Senior Member
Join Date: Sep 2008
Location: Eugene, Oregon
Posts: 347
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Re: Neratinib Trial 09
Sorry to hear that Mary Anne, and also glad for you that you were able to find out about that. I've been thinking that may be one of the advantages of consenting to the trial is the chance to be monitored closely and thoroughly examined, again. It seems like once you're out of regular treatment they don't really want to see much of you until you have something nasty pop up. I for one would rather be vigilant now, than sit and wait.
Keep us updated on your "electrical" issues. Would be interesting to learn more about that, for sure. Wonder if it's from Herceptin?
Enjoy your Thanksgiving and all the love in your life,
Celeste
__________________
"Dancers Against Cancer" in the Eugene, OR Komen Race for the Cure 2010
Diagnosed 8/7/08 with stage 3 invasive ductal carcinoma, micropapillary pattern, Her2 3+, ER+,PR-, grade II, positive lymph nodes.
Received 6doses of Taxotere, Carboplatin with Herceptin continuing for a year...DONE.
1/28/09 Left Modified Radical Mastectomy, Right Simple Mastectomy.
Surgery pathology: No invasive carcinoma present and 17 lymph nodes removed all negative! Only small amount of carcinoma in situ in left breast.
March/April '09, Radiation to left chest wall.
Currently involved in Neratinib clinical trial.
"Well being I won
and wisdom too,
I grew and joyed in my growth;
from a word to a word
I was led to a word
from a deed to another deed." (Odin)
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11-26-2009, 04:38 PM
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#32
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Senior Member
Join Date: Jun 2006
Location: San Antonio, TX
Posts: 2,357
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Re: Neratinib Trial 09
I would recommend anyone go for this trial....the drug is so promising. Of course, it has to be appropriate in all the right ways, but I would do it again if I could. They marked my chart to allow me to take the drug as soon as it is approved as along as my heart issues get solved. I'll look forward to seeing more people get involved in trials.
I wanted to be in the trial so that I would be observed carefully and that I would have a "reason" (I don't always take good care of me) to go faithfully for the next 5 years! It's hard to go from such incredible care to being a "well" person!
Best wishes to all those volunteering. ma
__________________
MA in TX.
Grateful for each and every day....
Diag. 12/05 at age 60
Stage II, Grade 3, 4.5 cm primary tumor
ER/PR- Her2 +3 strongly positive
Her2 by FISH 7.7 amplified
vascular invasion
Ki67 20% borderline
Jan - March '06 Taxotere/Adriamycin X 3 to try to shrink tumor - it grew
April '06 Rt Modified Radical Mas, 7 of 9 nodes positive
April - Aug. '06 Herceptin/Taxol/Carboplatin X 8 (dose dense)
Sept - Dec. '06 Navelbine/Herceptin x 8 (dose dense)
Radiation & Herceptin Jan. 22 - March 1, 2007
Finished Herceptin Dec. 10 '08! One extra year.
Port removed August, 2012.
8 1/2 years since diagnosis! 5 1/2 Years NED!
Last edited by Mary Anne in TX; 11-27-2009 at 07:15 AM..
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11-26-2009, 05:08 PM
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#33
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Senior Member
Join Date: Feb 2006
Location: Southern, CA
Posts: 2,511
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Re: Neratinib Trial 09
Awwww MA...I swear it's always something! I agree it's a good thing they found out there might be another problem before you got started on this trial...but I can sure imagine the disappointment you must feel.  I so admire the way you and your onc work together and stay on top of your bc. It's awful to have have a plan of action and have it fold like that. (As you know I've had alot of monkey wrenches thrown in my plans the last few months...it's so frustrating!) So my heart really goes out to you. But that being said I really do believe something good will come out of this. Something even better! At least this trial brought this to your attention now so that your cardio doc can tweak a few things and get you back in good shape.
Hang in there MA...keeping you in my thoughts & prayers always.
Chelee
__________________
DX: 12-20-05 - Stage IIIA, Her2/Neu, 3+++,Er & Pr weakly positive, 5 of 16 pos nodes.
Rt. MRM on 1-3-06 -- No Rads due to compromised lungs.
Chemo started 2-7-06 -- TCH - - Finished 6-12-06
Finished yr of wkly herceptin 3-19-07
3-15-07 Lt side prophylactic simple mastectomy. -- Ooph 4-05-07
9-21-09 PET/CT "Recurrence" to Rt. axllia, Rt. femur, ilium. Possible Sacrum & liver? Now stage IV.
9-28-09 Loading dose of Herceptin & started Zometa
9-29-09 Power Port Placement
10-24-09 Mass 6.4 x 4.7 cm on Rt. femur head.
11-19-09 RT. Femur surgery - Rod placed
12-7-09 Navelbine added to Herceptin/Zometa.
3-23-10 Ten days of rads to RT femur. Completed.
4-05-10 Quit Navelbine--Herceptin/Zometa alone.
5-4-10 Appt. with Dr. Slamon to see what is next? Waiting on FISH results from femur biopsy.
Results to FISH was unsuccessful--this happens less then 2% of the time.
7-7-10 Recurrence to RT axilla again. Back to UCLA for options.
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11-26-2009, 05:19 PM
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#34
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Senior Member
Join Date: May 2008
Location: Hershey, PA. Live The Sweet Life!
Posts: 2,005
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Re: Neratinib Trial 09
Mary Anne, I am very sorry to hear your news! Hopefully they can get your circuits back in sync without much ado! It's always something, isn't it? Dang this mortal coil!
__________________
Smile On!
Laurel
Dx'd w/multifocal DCIS/IDS 3/08
7mm invasive component
Partial mast. 5/08
Stage 1b, ER 80%, PR 90%, HER-2 6.9 on FISH
0/5 nodes
4 AC, 4 TH finished 9/08
Herceptin every 3 weeks. Finished 7/09
Tamoxifen 10/08. Switched to Femara 8/09
Bilat SPM w/reconstruction 10/08
Clinical Trial w/Clondronate 12/08
Stopped Clondronate--too hard on my gizzard!
Switched back to Tamoxifen due to tendon pain from Femara
15 Years NED
I think I just might hang around awhile....
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11-27-2009, 03:35 AM
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#35
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Senior Member
Join Date: Feb 2009
Posts: 1,526
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Re: Neratinib Trial 09
Mary-Anne soo sorry to hear for the moment that you can't join the trial but very glad they picked up the heart issue so it can be sorted quickly.
Could you tell me if neratinib is showing any promise for stage 4 bc?
Chelee, glad to hear from you and glad you're on the mend!
Ellie
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11-27-2009, 07:20 AM
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#36
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Senior Member
Join Date: Jun 2006
Location: San Antonio, TX
Posts: 2,357
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Re: Neratinib Trial 09
Neratinib is the same "kind" of drug as tykerb. It is very promising and the researchers are very excited because it too crosses the blood brain barrier and seems to work very well. I understand that if it trials well, it will get consideration to be hurried up thru getting to all us patients. I just wanted to be part of finding out if it will help us destroy the "evil BC"! But the answer is yes, I think so. I'll bet some of the others will know more than me. ma
__________________
MA in TX.
Grateful for each and every day....
Diag. 12/05 at age 60
Stage II, Grade 3, 4.5 cm primary tumor
ER/PR- Her2 +3 strongly positive
Her2 by FISH 7.7 amplified
vascular invasion
Ki67 20% borderline
Jan - March '06 Taxotere/Adriamycin X 3 to try to shrink tumor - it grew
April '06 Rt Modified Radical Mas, 7 of 9 nodes positive
April - Aug. '06 Herceptin/Taxol/Carboplatin X 8 (dose dense)
Sept - Dec. '06 Navelbine/Herceptin x 8 (dose dense)
Radiation & Herceptin Jan. 22 - March 1, 2007
Finished Herceptin Dec. 10 '08! One extra year.
Port removed August, 2012.
8 1/2 years since diagnosis! 5 1/2 Years NED!
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11-27-2009, 10:08 AM
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#37
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Senior Member
Join Date: Oct 2007
Posts: 1,851
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Re: Neratinib Trial 09
Mary Anne,
I'm sorry to hear that you're no longer in the Neratinib trial over a heart complication. But perhaps you were "lucky" that the trial discovered the problem and it can be remedied.
Joan
__________________
Diagnosed stage 2b in July 2003 (2.3 cm, HER2+, ER-/PR-, 7+ nodes). Treated with mastectomy (with immediate DIEP flap reconstruction), AC + T/Herceptin (off label). Cancer advanced to lung in Jan. 2007 (1 cm nodule). Started Herceptin every 3 weeks. Lung wedge resection April 2007. Cancer recurred in lung April 2008. RFA of lung in August 2008. 2nd annual brain MRI in Oct. 2008 discovered 2.6 cm cystic tumor in left frontal lobe. Craniotomy Oct. 2008 (ER-/PR-/HER2-) followed by targeted radiation (IMRT). Coughing up blood Feb. 2009. Thoractomy July 2009 to cut out fungal ball of common soil fungus (aspergillus) that grew in the RFA cavity (most likely inhaled while gardening). No cancer, only fungus. Removal of tiny melanoma from upper left arm, plus sentinel lymph node biopsy in Feb. 2016. Guardant Health liquid biopsy in Feb. 2016 showed mutations in 4 subtypes of TP53. Repeat of Guardant Health biopsy in Jana. 2021 showed 3 TP53 mutations, BRCA1 mutation and CHEK2 mutation. Invitae genetic testing showed negative for all of these. Living with MBC since 2007. Stopped Herceptin Hylecta (injection) treatment in March 2020. Recent 2021 annual CT of chest, abdomen and pelvis and annual brain MRI showed NED. Praying for NED forever!!
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11-28-2009, 08:11 AM
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#38
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Senior Member
Join Date: Feb 2009
Posts: 1,526
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Re: Neratinib Trial 09
Thanks Mary Anne
You have jogged my memory, my onc said exciting developments were happening with the p13k pathway and I think this may have been when he referred to it saying if we could block this we would have it under control.
Let's keep praying
Ellie
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11-28-2009, 09:26 AM
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#39
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Senior Member
Join Date: Jul 2006
Posts: 869
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Re: Neratinib Trial 09
Please excuse my ignorance, but I am confused, are those who are NED pursuing this trial or is it for continued disease progression? Ceesun
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11-29-2009, 06:05 AM
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#40
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Member
Join Date: Nov 2009
Posts: 11
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Re: Neratinib Trial 09
There is a trial for Stafe 3 and 4, but they recently opened a trial for Stage 1 and 2, NED, women who have finished Herceptin within 24 months- looking to see if neratinib can help prevent recurrence given after Herceptin. Im in the Stage 1/2 trial but Im not sure about everyone else on the board.
Kristy
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