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All TopicsForum: Clinical Trials, Research News, Podcasts, Study Results → Topic: Hormone Therapy with/without Afinitor (everolimus) SWOG-S1207

Topic: Hormone Therapy with/without Afinitor (everolimus) SWOG-S1207

Forum: Clinical Trials, Research News, Podcasts, Study Results —

Share your research articles, interpretations and experiences here. Let us know how these studies affect you and your decisions.

Posted on: Jul 16, 2014 01:55PM

Bec65 wrote:

I started this clinical trial in May 2014 and would like to connect with anyone else who is on it.  It's a Phase III trial for high risk hormone-positive, HER2- patients to see if adding one year of everolimus to hormone therapy improves disease-free survival.  Anyone?  

Also did one year clinical trial of Afinitor or placebo May 2014-15, and I think I got the drug! Dx 8/21/2013, ILC, Left, 4cm, Stage IIIA, Grade 2, 6/18 nodes, ER+/PR+, HER2- (FISH) Surgery 9/27/2013 Lymph node removal: Left; Mastectomy: Left; Prophylactic mastectomy: Right Chemotherapy 10/30/2013 AC + T (Taxol) Radiation Therapy 2/25/2014 Whole-breast: Breast, Lymph nodes Hormonal Therapy 4/10/2014 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone) Surgery 12/18/2014 Prophylactic ovary removal Hormonal Therapy 12/29/2014 Femara (letrozole)
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Jan 13, 2018 05:41PM DodgersGirl wrote:

cindysmom, I meet with MO Monday to talk about this trial. Can you tell me what the trial pays for in regards to tests and doctor visits?

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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Jan 13, 2018 05:42PM DodgersGirl wrote:

KPW3– so sorry you had progression. I hope you respond well to your next treatment.

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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Jan 13, 2018 07:25PM cindysmom wrote:

DodgersGirl-As far as I know it only pays for the drug everything else is considered normal care and they bill it to your insurance. Your responsible for anything they don't cover (insurance).

Dx 11/6/2016, IDC, Right, 1cm, Stage IIA, Grade 2, 2/9 nodes, ER+/PR+, HER2- Chemotherapy 11/26/2016 AC + T (Taxol) Surgery 4/5/2017 Lumpectomy; Lymph node removal: Sentinel, Underarm/Axillary Radiation Therapy 6/19/2017 Whole-breast: Breast, Lymph nodes Hormonal Therapy Femara (letrozole)
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Jan 14, 2018 05:36AM DodgersGirl wrote:

cindysmom, did you talk with your insurance before going on the study? If you did, wondering what kind of info did they ask you for?

Do you know if there are any CTs or scans done over the year for the clinical trial?

Sorry for all the questions.... just trying to wrap my head around all of this.

Thank you!!

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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Jan 14, 2018 07:42AM KPW3 wrote:

DodgersGirl, I didn't check with my insurance before hand....the study coordinator might have. I didn't have to have any additional scans, there were regular labs done, which I think my insurance covered-my cholesterol went up quite a bit, but did return to normal after the end of the trial (54 weeks is what I remember). I felt much better when the study was over...I had quite a bit of fatigue with the drug, but didn't realize how much until I was off the med. I think you cover any expenses like travel....

Dx 10/2014, IDC, 2cm, Stage IIB, Grade 3, 2/3 nodes, ER+/PR-, HER2- Surgery 1/28/2015 Lumpectomy Chemotherapy 3/2/2015 AC + T (Taxol) Surgery 7/22/2015 Lymph node removal: Underarm/Axillary Radiation Therapy 9/16/2015 Dx 11/29/2017, IDC, Left, Stage IV, metastasized to liver, Grade 3, ER-/PR-, HER2- Chemotherapy 6/13/2018 Halaven (eribulin) Chemotherapy Abraxane (albumin-bound or nab-paclitaxel) Hormonal Therapy Femara (letrozole), Zoladex (goserelin)
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Jan 14, 2018 07:51AM DodgersGirl wrote:

KWP3– thank you for sharing your experien

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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Jan 14, 2018 11:22AM cindysmom wrote:

DodgersGirl: I didn't check with my insurance company either, I know there are lots of labs and I'm scheduled for a PET scan in February. The only real problem I have is my blood sugar levels. Sometimes extra tired, sometimes kinda feel blah.

Dx 11/6/2016, IDC, Right, 1cm, Stage IIA, Grade 2, 2/9 nodes, ER+/PR+, HER2- Chemotherapy 11/26/2016 AC + T (Taxol) Surgery 4/5/2017 Lumpectomy; Lymph node removal: Sentinel, Underarm/Axillary Radiation Therapy 6/19/2017 Whole-breast: Breast, Lymph nodes Hormonal Therapy Femara (letrozole)
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Jan 14, 2018 12:14PM DodgersGirl wrote:

cindysmom— will keep you in my prayers for good PET results in February. Hope the blood sugar spikes go down after the trial.


Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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Jan 16, 2018 07:39AM DodgersGirl wrote:

cindysmom- had meeting with clinical trial nurse this week. Asked about glucose rises due to Everolimus. She said it is a know side effect and that they have a range you A1C needs to fall in so that you can continue with the trial. I don’t have the time can’t numbers but thought she said A1C had to be below 7.x.

I have the paperwork to review. I think I will do this trial even though a year of chemo pills doesn’t sound fun.

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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Jan 16, 2018 04:06PM cindysmom wrote:

DogersGirl: Your right a1c needs to be 7 or less, which it normally is but it just goes high with that medicine. I added a new drug to the rest of my meds hoping to get it down. I had to stop the Afintor until its under control again, I want to stay on this trial since I'm pretty sure I actually got the real drug. Outside of blood sugar levels I'm not having any other side effects. It sure beat IV chemo. Good luck if you decide to go for it, I hope all you se are minimal.



Dx 11/6/2016, IDC, Right, 1cm, Stage IIA, Grade 2, 2/9 nodes, ER+/PR+, HER2- Chemotherapy 11/26/2016 AC + T (Taxol) Surgery 4/5/2017 Lumpectomy; Lymph node removal: Sentinel, Underarm/Axillary Radiation Therapy 6/19/2017 Whole-breast: Breast, Lymph nodes Hormonal Therapy Femara (letrozole)
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Jan 16, 2018 04:12PM DodgersGirl wrote:

cindysmom— hope you get to continue with the trial.

I think I will sign up later this month. I have an appt with a surgeon next week. Need to see if clinical trial is a problem with a pending surgery

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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Jan 30, 2018 06:57PM SkiChick86 wrote:

Hi ladies! I’m so glad to find this thread and to see that it’s still somewhat active! I started on the Everolimus trial in early December. I knew right away I had the drug because the SEs were unreal. I got horrible mouth sores (my MO saw them and said “well, so much for the placebo!”) that were so bad we stopped the drug for about two weeks over Christmas. When I started back up I used the mouth wash which helped but the fatigue was debilitating. I also lost almost 10 pounds in a month because I have found the drug to be an appetite suppressant as well. Anyway I ended up having a breakdown in my oncologists office because I basically couldn’t function I was so tired and they gave me a weeklong break from the drug and then dropped me down to a half dose (5 mg). So far the reduced dose has been much more manageable.

I’m so glad to connect with others on this drug and it was SO helpful to read the experiences of those who are already done

Dx at 30 while 20 weeks pregnant with my second child Dx 1/4/2017, IDC, Left, 2cm, Stage IIIA, Grade 3, 4/8 nodes, ER+/PR+, HER2- Dx 1/4/2017, DCIS, Left, 6cm+, Stage 0, Grade 3, ER+/PR+, HER2- Chemotherapy 1/24/2017 AC Surgery Mastectomy: Left
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Jan 31, 2018 06:44AM DodgersGirl wrote:

SkiChick86– glad to see there are others on this trial. I will have a blood test to make sure my sugars are low enough to start the trial. So if all goes well, I should start this spring. I see the research nurse in a couple of weeks to sign the paperwork. I am concerned about the mouth sores. Was pleased to see you were able to continue on the trial with a lesser dose. That’s encouraging to me

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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Feb 2, 2018 07:15AM SkiChick86 wrote:

Dodgers - they were happy to lower the dose which made a HUGE difference. And not everyone gets the mouth sores! My oncologist said she’s prescribed the drug to stage IV patients who she knows are getting the actual drug (not part of a trial) and they haven’t had any side effects.

Dx at 30 while 20 weeks pregnant with my second child Dx 1/4/2017, IDC, Left, 2cm, Stage IIIA, Grade 3, 4/8 nodes, ER+/PR+, HER2- Dx 1/4/2017, DCIS, Left, 6cm+, Stage 0, Grade 3, ER+/PR+, HER2- Chemotherapy 1/24/2017 AC Surgery Mastectomy: Left
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Feb 2, 2018 09:45AM DodgersGirl wrote:

SkiChick86–thanks for the update. I talked to the research nurse this week. Will take a blood test after surgery to make sure I qualify and will then sign up for the trial.

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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Mar 9, 2018 01:42AM live_deliciously wrote:

hi everyone. Glad to see this thread has helped others. Im not on here quite as often as I used to be as I'm trying to lead my normal. But I still immensely care about all others in this same trial and will continue to pop in to give an update. Right after I got released to 6 month visits from 3 month visits with my onc I had my annual pelvic ultra sound to check my uterus to make sure its not thickening. This year it changed significantly as my lining went from 3mm to 12 mm. They flag anything over 10mm as suspect. I've been wintering away in the warm weather and head back to the states end of march. First of April I go to the gyno to see what they want to do about it. They are sure its from the tamoxifen. I was told there is a 1% chance of tomixifen causing uterus cancer. It may mean taking out the girly parts and switching to an ai. Will post back what they find.

Otherwise all else is fine. Full recovery from the the trial drug and it will be 4 years since diagnosis the end of this year. Time is flying by. Love to all.

Dx 12/2014, IDC, Right, 5cm, Stage IIIA, Grade 2, 7/14 nodes, ER+/PR+, HER2- Surgery 1/16/2015 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right; Prophylactic mastectomy: Left; Reconstruction (left): Tissue expander placement; Reconstruction (right): Tissue expander placement Chemotherapy 2/24/2015 AC + T (Taxol) Radiation Therapy 7/6/2015 Whole-breast: Breast, Lymph nodes, Chest wall Hormonal Therapy 8/20/2015 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone) Targeted Therapy Afinitor (everolimus)
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Mar 11, 2018 01:09PM cajunqueen15 wrote:

hi live - I had all my lady parts removed, shoot me a message if you have any questions! X

35 @ dx. BRCA2. Disciple, wife, mother of twins (5) & son (3), attorney. e3 trial (complete). Blue/MammaPrint, High-risk Luminal B. Prolia (start 6/16). Dx 7/22/2015, DCIS, Left, <1cm, Stage 0, Grade 3, ER+/PR+, HER2- Dx 8/28/2015, IDC, Left, 1cm, Stage IIA, Grade 3, 2/11 nodes, ER+/PR+, HER2- Surgery 8/28/2015 Lymph node removal: Sentinel, Underarm/Axillary; Mastectomy: Left, Right; Reconstruction (left): Tissue expander placement; Reconstruction (right): Silicone implant Surgery 4/12/2016 Prophylactic ovary removal Hormonal Therapy 4/19/2016 Arimidex (anastrozole) Surgery 8/1/2017 Reconstruction (left): Silicone implant Radiation Therapy Whole-breast: Breast, Lymph nodes, Chest wall Chemotherapy AC + T (Taxol)
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Mar 28, 2018 11:46AM DodgersGirl wrote:

Signed the paperwork today for this study. Should know in the next week if my blood work was good enough to be accepted.

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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Apr 1, 2018 03:33PM DodgersGirl wrote:

Blood work ok to start the clinical trial. Pick up the meds on Wednesday

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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Apr 4, 2018 08:33AM DodgersGirl wrote:

started the trial this morning. Everolimus or placebo? Which will it be??

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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Apr 4, 2018 09:20AM cindysmom wrote:

Dodgers Girl: You'll know soon! Good Luck and easy side effects.

Dx 11/6/2016, IDC, Right, 1cm, Stage IIA, Grade 2, 2/9 nodes, ER+/PR+, HER2- Chemotherapy 11/26/2016 AC + T (Taxol) Surgery 4/5/2017 Lumpectomy; Lymph node removal: Sentinel, Underarm/Axillary Radiation Therapy 6/19/2017 Whole-breast: Breast, Lymph nodes Hormonal Therapy Femara (letrozole)
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Apr 4, 2018 09:29AM DodgersGirl wrote:

cindysmom— thanks!!

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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Apr 26, 2018 11:27AM DodgersGirl wrote:

Been taking my trial meds now for 3 weeks and have a few mouth sores developing. So far, they are tolerable.

Developed a bit of a dry cough 10 days ago or so. Have some leg cramps and back pain but nothing really awful.

Three weeks down and 51 more to go.

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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May 5, 2018 03:18PM cajunqueen15 wrote:

You got this, Dodgers!!!

35 @ dx. BRCA2. Disciple, wife, mother of twins (5) & son (3), attorney. e3 trial (complete). Blue/MammaPrint, High-risk Luminal B. Prolia (start 6/16). Dx 7/22/2015, DCIS, Left, <1cm, Stage 0, Grade 3, ER+/PR+, HER2- Dx 8/28/2015, IDC, Left, 1cm, Stage IIA, Grade 3, 2/11 nodes, ER+/PR+, HER2- Surgery 8/28/2015 Lymph node removal: Sentinel, Underarm/Axillary; Mastectomy: Left, Right; Reconstruction (left): Tissue expander placement; Reconstruction (right): Silicone implant Surgery 4/12/2016 Prophylactic ovary removal Hormonal Therapy 4/19/2016 Arimidex (anastrozole) Surgery 8/1/2017 Reconstruction (left): Silicone implant Radiation Therapy Whole-breast: Breast, Lymph nodes, Chest wall Chemotherapy AC + T (Taxol)
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May 5, 2018 04:24PM DodgersGirl wrote:

cajunqueen15– thanks. I think I will be ok if the rest of the trial continues as what I have so far. Very doable after a month on the trial

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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May 12, 2018 04:42AM live_deliciously wrote:

hi everyone I haven't posted here for a while. I wanted to give an update that I had my check for my thickened uterus lining. I had a biopsy done and it all came back negative the doctor suggested several things for me for weight loss,preventing return of cancer Etc. He suggested intermittent fasting and time restricted diet and told me to look it up online. he was a gynecologist and I ran what he said by my oncologist and learned that she had just gone on the same program that's called fat for fuel by dr. McCullough. she said it would be safe for me to be on as well. So i did it and I've been on it for about 3 weeks now and it has really made a huge difference for me.


Dx 12/2014, IDC, Right, 5cm, Stage IIIA, Grade 2, 7/14 nodes, ER+/PR+, HER2- Surgery 1/16/2015 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right; Prophylactic mastectomy: Left; Reconstruction (left): Tissue expander placement; Reconstruction (right): Tissue expander placement Chemotherapy 2/24/2015 AC + T (Taxol) Radiation Therapy 7/6/2015 Whole-breast: Breast, Lymph nodes, Chest wall Hormonal Therapy 8/20/2015 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone) Targeted Therapy Afinitor (everolimus)
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May 14, 2018 03:30PM DodgersGirl wrote:

live_deliciously— woot woot on clear biopsy!!!


Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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May 18, 2018 02:46AM DodgersGirl wrote:

just had my first blood work since starting SWOG Trial. I haven’t seen the full report yet as it isn’t on my patient portal yet. MOs office called yesterday to tell me my cholesterol numbers went down slightly and blood sugar was elevated. (I started taking a cholesterol lowering non prescription med just before starting this trial so thinking that is why my numbers were slightly lower).

I had have 2 mouth sores and many occasions of my mouth feeling sore but no sores appearing. Don’t know if that is because I am using a prescribed mouthwash or because I am on the placebo???

My throat has been sore for weeks. No fever just spots like the Everolimus is causing them where the mouth wash doesn’t reach? MO prescribed something to swallow to help with sore throat.

I am feeling tired but not sure it’s Everolimus related.

Sinuses are dry like when on chemo. Dry cough, too.

Overall, I don’t see an issue with making it thru this trial if these are the side effects to live through

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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Jun 6, 2018 10:16AM DodgersGirl wrote:

have 2 active mouth sores right now. Using the special mouthwash and Orajel

Otherwise, symptoms remain stable—. Dry sinuses, occasional night sweats, mouth sores, fatigue.

Dx 3/10/2017, IDC, Right, Stage IIIB, Grade 2, ER+/PR+, HER2- Chemotherapy 4/5/2017 AC + T (Taxol) Surgery 9/11/2017 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right Radiation Therapy 10/23/2017 Whole-breast: Breast, Lymph nodes
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Jun 24, 2018 02:19PM live_deliciously wrote:

Dodgers girl. Sounds like you are well on your way to the end of the trial. Best of luck.



Dx 12/2014, IDC, Right, 5cm, Stage IIIA, Grade 2, 7/14 nodes, ER+/PR+, HER2- Surgery 1/16/2015 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right; Prophylactic mastectomy: Left; Reconstruction (left): Tissue expander placement; Reconstruction (right): Tissue expander placement Chemotherapy 2/24/2015 AC + T (Taxol) Radiation Therapy 7/6/2015 Whole-breast: Breast, Lymph nodes, Chest wall Hormonal Therapy 8/20/2015 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone) Targeted Therapy Afinitor (everolimus)

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