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Topic: Bazedoxifene stops breast cancer resistant growth

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

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

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Jun 17, 2013 12:01PM cp418 wrote:

There is no United States FDA approval for bazedoxifene to date..



HERE Is the problem....

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Jun 17, 2013 12:18PM blainejennifer wrote:

As best as I can tell, Pfizer was going for approval for bazodoxifene as an osteoporosis drug, and the SEs were a little wacky, and there were other drugs that did just as well for bone strengthening, so it wasn't approved.

Given its recently discovered ability to destroy estrogen receptor sites, I'm hoping Pfizer puts in for expedited review by the FDA, or I'm gonna have to do some traveling.

ER/PR+, HER2-, Grade 3. Stage 4, July 2012. Currently on Gemzar/Carboplatin Dx 5/2006, IDC, 4cm, Stage IIB, Grade 3, 4/12 nodes, ER+/PR+, HER2- Dx 3/2012, IDC, Stage IV, 4/12 nodes, ER+/PR+, HER2- Chemotherapy 6/28/2012 Taxol (paclitaxel) Hormonal Therapy 6/5/2013 Faslodex (fulvestrant) Chemotherapy 7/1/2014 Xeloda (capecitabine) Hormonal Therapy 8/14/2015 Femara (letrozole) Chemotherapy 1/31/2016 Halaven (eribulin) Chemotherapy 8/31/2016 CMF Chemotherapy 11/1/2016 Halaven (eribulin) Chemotherapy Carboplatin (Paraplatin), Gemzar (gemcitabine)
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Jun 17, 2013 04:39PM mike3121 wrote:

Wow, isn't this like major news. My wife was diagnosed Stage 4 BC, estrogen type with mets to the spine. They tried taxol but she almost died from an adverse reaction. AC did the trick and she's in remission. Her oncologist told her that her blocker tamoxifen would work for 2 to 5 years then the cancer would come back. This new discovery for the use of this unpronounceable drug from Europe sounds like a major, MAJOR discovery. Why haven't their been like 90 comments to this thread?

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Jun 17, 2013 05:09PM hopefour wrote:

I am excited about this...gives us ER+PR+ a new treatment and hope!! Hope all goes well with it being approved in the US; and all ER+ PR+ BC patients see this and can pursue this knowledge for their own health care!!

Dx 5/2011, IDC, 1cm, Stage IIIA, Grade 1, 4/22 nodes, ER+/PR+, HER2-
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Jun 17, 2013 07:56PM beckylynn wrote:

I would like to see a comparison between Bazedoxifene and Zometa.  This is not the first bone-strengthening drug to be used for breast cancer, in addition to helping with bone loss.  I just wonder if this is TRULY a novel thereapy.  Hopeful, but not getting my hopes WAY up just yet.

Dx 3/2003, ILC, 5cm, Stage IIIC, 1/11 nodes, ER+/PR+, HER2- Surgery 4/6/2003 Mastectomy: Right Chemotherapy 5/5/2003 Adriamycin (doxorubicin), Cytoxan (cyclophosphamide), Taxotere (docetaxel) Radiation Therapy 8/1/2003 Breast, Lymph nodes Hormonal Therapy 9/13/2003 Surgery 4/22/2004 Prophylactic mastectomy: Left; Reconstruction (left): IGAP flap; Reconstruction (right): IGAP flap Dx 9/2005, ILC, Stage IV, mets, ER+/PR+, HER2- Surgery 9/21/2005 Prophylactic ovary removal Hormonal Therapy 10/20/2005 Faslodex (fulvestrant) Dx 8/2011, ILC, 6cm+, Stage IV, mets, ER-/PR-, HER2- Chemotherapy 9/28/2011 Xeloda (capecitabine) Hormonal Therapy 8/21/2012 Femara (letrozole) Hormonal Therapy 2/5/2013 Aromasin (exemestane) Targeted Therapy 2/5/2013 Afinitor (everolimus) Chemotherapy 7/24/2013 Xeloda (capecitabine) Chemotherapy 3/24/2014 Halaven (eribulin)
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Jun 18, 2013 01:26PM Husband11 wrote:

Very interesting.  But I didn't see any mention of it's testing on humans for cancer treatment, it just says animal and in vitro studies.  Anyone find anything showing application to human cancer patients?

beckylynn, it works very differently than the bisphosphonate bone strengthening drugs like zometa.  The bisphosponates interupt the reuptake and turnover of calcium containing bone cells.  This Bazedoxifene acts instead like estrogen, as it is a SERM, mimicking estrogen in bone tissue and thus acting like hormone replacement therapy to the bones.  Tamoxifen does the same thing, strengthening bones by mimicking estrogen.

I hope they can do some retrospective analysis of women who were previously on Bazedoxifene and see if it impacted those who had breast cancer, or perhaps reduced the rate of breast cancer in women on it.

Concerned husband Dx 2008, Left, Stage IIIB, Grade 3, 7/14 nodes, ER+/PR+, HER2- Dx 5/2016, Stage IV, metastasized to liver, ER+/PR+, HER2- Hormonal Therapy Femara (letrozole) Targeted Therapy Ibrance (palbociclib) Chemotherapy Xeloda (capecitabine)
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Jun 22, 2013 02:58PM Happy4Hanna wrote:

No human trials appear to have been published for bazedoxifene yet. The preclinical experiments have popped up from time to time over the past several years. Most interesting were studies n immune suppressed mice carrying grafted human breast tumours. The new study has additional information, that BZE may be able to prevent resistance to a treatment drug.
BZE has only been approved as a bone density drug for a couple of years, in a few European and Asian markets, so it is unlilkely that there are any human data for breast cancer yet. Let's hope that clinicians who are prescribing this drug will begin to track this data now. Pfizer may have human studies in mind, as they have funded the preclinical research.
Our best bet for the moment is to hope for speedy FDA approval of Aprela which has been submitted by Pfizer. It is a combination of BZE and estrogen, possibly safe as the BZE is believed to suppress the estrogen receptors in breast (based on preclinical studies) and uterine tissue but not bone.

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Jun 22, 2013 04:19PM sciencegal wrote:

Hi girls, there is another post about this called, "did anyone see this", and the scientist who has done the study, Dr. Wardell, was nice enough to post on that board. Maybe check it out.

It is in the "stage 4 only" board so I did not post back, out of respect for them, but had wanted to say how nice it was for him to post. He said other drugs are coming too.

It is always so great to read these new developments that might help us.

Peace and Hugs to all.

My friends saved my hair through chemo with Penguin Cold Caps. Thank you capping crew!! Now NED 5 years out. Hang in there! Dx 10/19/2012, IDC, 6cm+, Stage IIB, Grade 3, 3/4 nodes, ER-/PR-, HER2+ Surgery 11/1/2012 Lymph node removal: Left, Sentinel Targeted Therapy 11/6/2012 Herceptin (trastuzumab) Chemotherapy 11/6/2012 Carboplatin (Paraplatin), Taxotere (docetaxel) Surgery 3/18/2013 Lymph node removal: Left, Underarm/Axillary Surgery 3/18/2013 Mastectomy: Left; Reconstruction (left): Tissue expander placement Surgery 5/22/2013 Reconstruction (left) Radiation Therapy 6/26/2013 Breast Surgery 9/25/2014 Reconstruction (left); Reconstruction (right)
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Jun 23, 2013 08:49AM Heidihill wrote:

I don't have the link anymore but I seem to remember seeing something to the effect that BZA combined with conjugated estrogen had no effect on breast cancer recurrence.

Dx 8/2007, IDC, Left, 2cm, Stage IV, metastasized to bone, Grade 2, 2/19 nodes, mets, ER+/PR+, HER2- (FISH) Hormonal Therapy 3/25/2015 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Jun 28, 2013 05:06PM - edited Jun 28, 2013 05:16PM by jenrio

This is the post sciencegal mentioned: 

http://community.breastcancer.org/forum/8/topic/806200

Pfizer is in the process of deciding whether to allow this drug be tested for MBC patients or neoadjuvantly.   

So let us early stagers help ourselves out by helping the metsters,   here is Pfizer's contact information:

Customer Service and Product Inquiries: 
1-800-TRY-FIRST (1-800-879-3477) 
Monday through Friday 8:00 a.m. to 8:00 p.m. EST 

Corporate Office: 
1-212-733-2323 
235 East 42nd Street 
New York, NY 10017

Call/email and mention this drug and ask for a clinical trial to start for breast cancer.



iir@pfizer.com

http://www.pfizer.com/contact/email_contact.jsp?inquiry=Clinical+Research&x=20&y=18



more details in my blog killerboob.blogspot.com
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Jul 11, 2013 10:43AM hopefour wrote:

Thank you for this information, well for sure call...hope this drug is another tool in the fight!

Dx 5/2011, IDC, 1cm, Stage IIIA, Grade 1, 4/22 nodes, ER+/PR+, HER2-
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Jul 11, 2013 04:54PM - edited Jul 12, 2013 11:11AM by TarheelMichelle

Sciencegal, you are such a smart cookie, I thought you were Stage IV. I guess I didn't pay as much attention as I should have to your diagnosis details. (Not trying to say that lower stagers are dummies, of course!) Thanks for redirecting these ladies to the other post. I'm not sure who got Dr. W. to post (was it you?) but her experience, wisdom and kindness are exceptional. Even if a lady is not interested in the specific treatment, I urge everyone to read it, to get an idea of the journey treatments take from the lab to our dr.'s office.

Ronda - Extensive mets to lungs & bones. My life is Stage IV precious. Celebrating 8 years with Stage IV 12/2019 Dx 2/14/2008, IDC, Left, 1cm, Stage IA, Grade 2, 0/3 nodes, ER+/PR+, HER2- Surgery 3/11/2008 Lumpectomy: Left; Lymph node removal: Left, Sentinel Radiation Therapy 4/17/2008 Dx 12/19/2011, Stage IV, metastasized to bone/lungs, mets, ER+/PR+, HER2- Hormonal Therapy 1/31/2012 Aromasin (exemestane) Hormonal Therapy 12/19/2012 Faslodex (fulvestrant) Hormonal Therapy 7/16/2013 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone) Surgery 4/24/2014 Reconstruction (left) Radiation Therapy 11/21/2014 External: Bone Targeted Therapy 11/17/2015 Afinitor (everolimus) Targeted Therapy 5/20/2016 Hormonal Therapy 6/1/2016 Femara (letrozole) Hormonal Therapy Faslodex (fulvestrant) Targeted Therapy Ibrance (palbociclib)
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Jul 22, 2013 02:32PM cp418 wrote:

http://community.breastcancer.org/forum/8/topic/806200?page=3#post_3635619

Please read further VERY IMPORTANT ongoing research regarding Bazedoxifene and preventing mets.  As patients we need to be aware of current treatments and ongoing research BUT ALSO possible life saving medications that may be hung up by BIG PHARMA.  

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Jul 22, 2013 04:00PM - edited Jul 22, 2013 04:02PM by cp418

http://www.medicalnewstoday.com/articles/262039.php

Osteoporosis Drug Bazedoxifene Stops Growth Of Breast Cancer Cells

Bazedoxifene, an osteoporosis medication which is approved in Europe, stops the growth of breast cancer cells, including those that are resistant to current medications, researchers from the Duke Cancer Institute reported at ENDO 2013 - The Endocrine Society's Annual Meeting in San Francisco, California, June 15th, 2013.



http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3383524/

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Jul 22, 2013 05:13PM geewhiz wrote:

It's very fascinating isn't it? Hard not to get goose bumps.
Thanks as always cp418. I read everything you post and alter course occasionally as a result. Your hard work is so appreciated!

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Jul 22, 2013 05:23PM geewhiz wrote:

Am I reading all these posts clearly?
It's approved here in the US as an osteoporosis drug?
My onc gave me zometa for a year citing "osteoporosis" after a scan, cough. So I could theoretically get baz here for that same reason?

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Jul 22, 2013 05:41PM cp418 wrote:

http://community.breastcancer.org/forum/8/topic/806200?page=3#post_3635619

This link is from our Stage 4 forum.

geewhiz - if you go to this link there is much information about the development history of this drug. It is currently aprroved and used in Europe to treat osteoporosis but is NOT available for use in the USA.  Dr Wardells one of the key researcher kindly posted details about their Bazedoxifene research and how it destroys estrogen resceptors - - possibly preventing mets.  This is MAJOR research break through but for some reason the Pharma Companies are not pursuing it's approval for use here.  As breast cancer patients in the USA  - we need to be heard to make it available here.

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Jul 22, 2013 06:25PM LtotheK wrote:

What can we do??

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Jul 22, 2013 06:59PM geewhiz wrote:

I can't seem to find it as available in Canada either.
Frustrating.

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Jul 22, 2013 08:27PM cp418 wrote:

In Dr Wardells replies he described the following situation. - "Pfizer currently has no plans to either evaluate this drug in breast cancer treatment or to license it as an osteoporosis treatment in the USA.  That being said, if there is medical justification, the drug might be obtained from Pfizer through compassionate use.  You can address that with your Dr.

I would emphasize that their decision was based on sound reasoning from their perspective, and that NONE of that had to do with the potential usefulness of BZA.  If Pfizer chooses to change their plan, it will be because enough people asked them to."

--------------------------------------------------------------------------

I think because there is much interest and activity on this topic in the Stage 4 forum link - maybe we should contain our replies there.

I'm wondering if setting up an online Petition (some how?) to get the attention of Pfizer and the FDA??  Show numbers of patients who want this drug made available in USA, Canada, Australia in addition to writing individual letters.  We need to make a lot of noise to get noticed I think......

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Jul 23, 2013 09:57PM cp418 wrote:

http://community.breastcancer.org/forum/8/topic/806200?page=3#post_3637684

I would like to start a petition to Pfizer to get BZA registered in the USA. We need to get the same access to this drug as patients in Europe treated for osteoporosis.  This first step in access may help get additional clinical trials started for use in breast cancer. 

Please post or forward to me your wording, ideas, suggestions for how to write and word this petition.  Writing is not my strength and I want to clearly communicate and include your thoughts, feelings, concerns for breast cancer patients in the USA to get the same access to this medication.  I feel it is critical that the Pfizer executives hear us loud and clear, in addition to our individual letters.  We need to get their attention to hear our request. 

If getting this drug available in the USA will benefit patients like in Europe - - it will be well worth our efforts. 

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Jul 24, 2013 10:46PM hopefour wrote:

cp418..thank you for the many insightful posts. I have been following this thread as well as the thread on stage IV...out of respect for them I have not posted there...but very much support the idea of being heard.  I want this drug for my stage IV sisters as well as all BC patients in the USA. I have sent a email, but am interested to know if there is any further action I can take. Thank you again for your passion for knowledge in the BC fight and your willingness to share it with us. 

Dx 5/2011, IDC, 1cm, Stage IIIA, Grade 1, 4/22 nodes, ER+/PR+, HER2-
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Jul 25, 2013 02:20PM LtotheK wrote:

I googled petitions online, and found something I think may be usable to "plug and play".  I tweaked it a bit. Let's do this.

I hereby urge Pfizer corporation leaders (?), to act immediately to treat women with resistant breast cancers, by making the drug Bazidozefine available as quickly as possible.  This drug is used for osteoporosis in Europe, and according to Duke University Medical Center Cancer Institute's study, has been shown to stop the growth of breast cancer cells.  This is a major breakthrough for breast cancer patients.

We petition you to begin immediate approval for the drug Bazidoxefine which has been proven to halt resistant cancer growth, even in cancers that have become resistant to current targeted therapies. Without this medication, women will die.

We further insist that you find ways to bring this medication to the market for all patients who can benefit from its safe usage. We beg you to allow further trials for this drug following FDA guidelines and to encourage further research to determine genetic markers for women who might benefit from it.

 

Thanks to a provision in the FDA Safety and Innovation Act of 2012 that compels the FDA to create a new status, known as a “breakthrough” designation, for treatments for life-threatening diseases where “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies, making this drug available should be easier for Pfizer than ever.

Because bazedoxifene has already undergone safety and efficacy studies as a treatment for osteoporosis, it may be a viable option for patients with advanced breast cancer whose tumors have become resistant to other treatment options.

We are a civilized society that values life. We also cherish individual freedom and the right of a patient to choose her medical options with her physician. By acting on this, you will confirm our belief that Life, Liberty and the Pursuit of Happiness is an inalienable right for all, including the seriously ill.

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Jul 25, 2013 08:35PM hopefour wrote:

Thank you for taking the time to research and write this. I am not one to articulate a letter to send to a large corporation in hopes to persuade them to make this drug available. I hope this idea does move forward and is effective in achieving the goal of allowing this drug to be used in the USA. If it moves forward I'll post it on the stage III thread to hopefully gain support. Thank you again.

Dx 5/2011, IDC, 1cm, Stage IIIA, Grade 1, 4/22 nodes, ER+/PR+, HER2-
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Jul 25, 2013 10:04PM Denise-G wrote:

LtotheK - great job.  I will be watching this and getting the word out.

www.denise4health.wordpress.com my BC Blog with over 200 informative posts about all aspects of BC - stop by! Myself, my mom, and sister were all diagnosed with BC within 3 years. What a ride! Dx 10/10/2011, IDC, Left, 6cm+, Stage IIIA, Grade 2, 9/14 nodes, ER+/PR+, HER2+ (FISH) Surgery 11/22/2011 Lymph node removal: Left, Underarm/Axillary; Mastectomy: Left Chemotherapy 12/26/2011 AC + T (Taxol) Targeted Therapy 2/27/2012 Herceptin (trastuzumab) Hormonal Therapy 10/10/2012 Arimidex (anastrozole)
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Jul 25, 2013 10:29PM cp418 wrote:

THanks LtotheK!  This is an excellent petition!  I'm just waiting to hear back from another poster who has some pharma contacts in Europe.  Then consolidate any additional feedback we get to setup a draft --review ---> push GO button.  I am very glad to see the interest and hope we can get Pfizer's attention to help patients here.  I'm not sure how it works but maybe a USA registration would also impact availability for patients in Canada too.

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Jul 26, 2013 01:56PM cp418 wrote:

http://www.ncbi.nlm.nih.gov/pubmed/23165656

Cost-effectiveness of bazedoxifene compared with raloxifene in the treatment of postmenopausal osteoporotic women.

Abstract

Bazedoxifene is a novel selective estrogen receptor modulator (SERM) for the prevention and treatment of osteoporosis. In addition to the therapeutic value of a new agent, evaluation of the cost-effectiveness compared with relevant alternative treatment(s) is an important consideration to facilitate healthcare decision making. This study evaluated the cost-effectiveness of bazedoxifene compared with raloxifene for the treatment of postmenopausal women with osteoporosis. The cost-effectiveness of treatment for 3 years with bazedoxifene was compared with raloxifene using an updated version of a previously validated Markov microsimulation model. Analyses were conducted from a Belgian healthcare payer perspective and, the base-case population was women (aged 70 years) with bone mineral density T-score ≤ -2.5. The effects of bazedoxifene and raloxifene on fracture risk were derived from the 3-year results of a randomized, double-blind, placebo-controlled and active-controlled study, including postmenopausal women with osteoporosis. The cost-effectiveness analysis based on efficacy data from the overall clinical trial indicated that bazedoxifene and raloxifene were equally cost-effective. When the results were examined based on the subgroup analysis of women at higher risk of fractures, bazedoxifene was dominant (lower cost for higher effectiveness) compared with raloxifene in most of the simulations. Sensitivity analyses confirmed the robustness of the results, which were largely independent of starting age of treatment, fracture risk, cost, and disutility. In addition, when the cost of raloxifene was reduced by one-half or when incorporating the raloxifene effects on reducing breast cancer, bazedoxifene remained cost-effective, at a threshold of €35,000 per quality-adjusted life-years gained, in 85% and 68% of the simulations, respectively. Under the assumption of improved antifracture efficacy of bazedoxifene over raloxifene in women with high risk of fractures, this study suggests that bazedoxifene can be considered cost-effective, and even dominant, when compared with raloxifene in the treatment of postmenopausal osteoporotic women.

Copyright © 2013 American Society for Bone and Mineral Research.

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Jul 26, 2013 01:58PM - edited Jul 29, 2013 09:14AM by cp418

http://www.news-medical.net/news/20130617/Bazedoxifene-used-for-treating-osteoporosis-stops-growth-of-breast-cancer-cells.aspx

A drug approved in Europe to treat osteoporosis has now been shown to stop the growth of breast cancer cells, even in cancers that have become resistant to current targeted therapies, according to a Duke Cancer Institute study.



http://www.sciencedaily.com/releases/2013/06/130615152341.htm

Osteoporosis Drug Stops Growth of Breast Cancer Cells, Even in Resistant Tumors, Study Suggests

A drug approved in Europe to treat osteoporosis has now been shown to stop the growth of breast cancer cells, even in cancers that have become resistant to current targeted therapies, according to a Duke Cancer Institute study.

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Jul 28, 2013 09:13PM hopefour wrote:

Thank you for staying on top of this!!

Dx 5/2011, IDC, 1cm, Stage IIIA, Grade 1, 4/22 nodes, ER+/PR+, HER2-
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Jul 30, 2013 04:59PM Denise-G wrote:

There is a petition on these boards...

www.denise4health.wordpress.com my BC Blog with over 200 informative posts about all aspects of BC - stop by! Myself, my mom, and sister were all diagnosed with BC within 3 years. What a ride! Dx 10/10/2011, IDC, Left, 6cm+, Stage IIIA, Grade 2, 9/14 nodes, ER+/PR+, HER2+ (FISH) Surgery 11/22/2011 Lymph node removal: Left, Underarm/Axillary; Mastectomy: Left Chemotherapy 12/26/2011 AC + T (Taxol) Targeted Therapy 2/27/2012 Herceptin (trastuzumab) Hormonal Therapy 10/10/2012 Arimidex (anastrozole)

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