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Topic: < 5 mm HER2+ IDC...why NOT chemo???

Forum: HER2+ (Positive) Breast Cancer —

Testing, treatment, side effects, and more.

Posted on: Jan 27, 2012 10:57AM

dancetrancer wrote:

I've read thread after thread and all of the info, opinions are running together in my head.  I've only had since yesterday to absorb all of this (was up til 1 a.m reading).  I know this is a controversial topic, but I want to hear why you WOULDN'T recommend chemo for < 5 mm of IDC her2+ (mine is 3 mm).

I had my tests run at Emory (I was there for a 3rd opinion on radiation).  They found the IDC (3 other facilities missed it, including UAB) and tested it for Her2.  Transferred my results to UAB.  Found out I was HER2+ yesterday.

UAB told me yesterday afternoon, lets cancel your radiation, meet with onc to discuss chemo next week.  Go ahead and rip your rads stickers off.  So I did.

Today they call me and say, nope, we talked to the onc and they said chemo isn't warranted with your small cancer.  Come back in to get the marks drawn back on, b/c we want to start rads ASAP next week, you are already behind schedule.

So, I've got a call into Emory to see what their onc says.  WTF.  I'm so sick and tired of sleepless nights, changing opinions, thinking I'm going to die if I don't do chemo (OK, I know that's overreacting, but you all know how it goes) and convincing myself to do it, then I hear, nope, you don't need it.  I could do without this emotional rollercoaster, thank you very much.  Now I'm afraid to NOT have chemo and am paranoid about recurrence.

HELP talk me down off the ledge please!  (LOL, just kidding, but d*mn!) 

Cold caps work! coldcapphotos.shutterfly.com/p... TCH: 4/10 - 6/13/12; 33 rads; BMX w/fat grafting; DX: 7/29/11 @ age 43: Stage 1A on L (3 mm IDC w/ 6 cm DCIS, Gr 2 ER/PR+, HER2+) 0/3 nodes; Stage 0 on R (2 mm DCIS); see bio.
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Apr 9, 2012 01:35PM - edited Apr 9, 2012 01:36PM by vjm

Dear Chachamom - Mine was 4mm and no nodes and I too thought I would be done after my final radiation treatment on Thursday. The more research I did and upon further consult with my onc and three leading specialists in HER2+ the more I realized what an aggressive little bugger this was. For me, I felt I needed to do everything possible so I wouldn't look back with regrets and they supported this decision. Chemo/herceptin combined is recommeded as the chemo seems to bump up the effectiveness of herceptin. Although early stages, I am starting a 4 cycle chemo on Friday and herceptin for one year. The niggle I had since original treatment protocol has completely gone away and I am sleeping well at night - at peace with my decision. Good luck with making yours - you'll know if it's right for you and we will all support you on that journey. Cheers, vjm.

Dx 10/28/2011, IDC, <1cm, Stage IA, Grade 3, 0/2 nodes, ER+/PR+, HER2+ Surgery 11/29/2011 Lumpectomy: Right Surgery 12/28/2011 Lumpectomy: Right; Lymph node removal: Right, Sentinel Radiation Therapy 3/12/2012 Breast Targeted Therapy 4/13/2012 Herceptin (trastuzumab) Chemotherapy 4/13/2012 Cytoxan (cyclophosphamide), Taxotere (docetaxel) Hormonal Therapy
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Apr 9, 2012 02:04PM - edited Apr 9, 2012 02:05PM by not

Hi Chachamom. I called the cancer society (from phone book) and got in touch with a Nurse Navigator from the local hospital cancer center. She's very helpful if you want to go the allopathic route. She gave me a binder with lots of info and questions, and a BC book. It's free and they have a bunch of groups you can join.

She also knows all the doctors and got me in to see them sooner.

XO

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Apr 9, 2012 10:56PM chachamom wrote:

Thanks vim and not! I think I'm obsessing and making myself crazy!.....so I plan on trying to relax, get off the couch and stay busy (can these be oxymorons?) until I have my pathology report in hand on Thursday. I DID get off the couch long enough to buy a binder to start my book of knowledge!....now I just need to get motivated enough to take it out of the bag lol!

Jill. Age 59. "Life is a shipwreck, but we must not forget to sing in the lifeboats." - Voltaire. No chemo/herceptin and no radiation because the largest of multi focal tumors was 3mm Dx 3/12/2012, IDC, <1cm, Stage IA, Grade 2, 0/5 nodes, ER+/PR+, HER2+ Hormonal Therapy 5/30/2012
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Apr 9, 2012 11:45PM not wrote:

Join the club Chachamom!  I'm driving myself crazy about what treatment to do. We're both HER2+ and that makes me feel more pressured to decide quickly. You're lucky you had no nodes involved!

I got valium and buspar from my primary doc because I'm freaking out so much!

XO

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Apr 10, 2012 01:52AM AlaskaAngel wrote:

vjm,

Could you post the adjuvant studies that demonstrate that "chemo seems to bump up the effectiveness of herceptin"?

Thanks

Dx 12/3/2001, DCIS/IDC, Left, 1cm, Stage IA, Grade 3, 0/1 nodes, ER+/PR+, HER2+ (IHC) Surgery 1/2/2002 Lumpectomy: Left; Lymph node removal: Left, Sentinel Chemotherapy 3/11/2002 Adriamycin (doxorubicin), Cytoxan (cyclophosphamide), Fluorouracil (5-fluorouracil, 5-FU, Adrucil) Radiation Therapy 9/9/2002 Breast Hormonal Therapy 11/14/2002 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Apr 10, 2012 05:57AM dancetrancer wrote:

AA, I do believe I have that data somewhere...I don't have time to find it right now (starting chemo this morning), but feel free to bump this thread and remind me in a few days.  

Cold caps work! coldcapphotos.shutterfly.com/p... TCH: 4/10 - 6/13/12; 33 rads; BMX w/fat grafting; DX: 7/29/11 @ age 43: Stage 1A on L (3 mm IDC w/ 6 cm DCIS, Gr 2 ER/PR+, HER2+) 0/3 nodes; Stage 0 on R (2 mm DCIS); see bio.
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Apr 10, 2012 06:10AM suzieq60 wrote:

AA - here's a couple

http://www.sciencedaily.com/releases/2009/12/091212141414.htm

http://www.herceptin.com/hcp/treatment/adjuvant/studies.html

http://insciences.org/article.php?article_id=7915

2nd diagnosis October 2010 - IDC 5.8mm node negative - missed on mammogram in October 2009 Dx 10/13/2009, ILC, 1cm, Stage I, Grade 3, 0/5 nodes, ER+/PR+, HER2+
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Apr 10, 2012 07:35AM voraciousreader wrote:

Alaska Angel... YOU KNOW VERY WELL THAT THERE IS EXACTLY ONE STUDY THAT IS SEEKING TO DETERMINE THE EFFECTIVENESS OF HERCEPTIN MONOTHERAPY AND THAT INVOLVES A POPULATION OF HER2+ PATIENTS OVER THE AGE OF 70.  AND YOU ALSO KNOW THAT IT WOULD BE ETHICALLY CHALLENGING TO SUGGEST DOING JUST HERCEPTIN WITH YOUNGER PATIENTS.  YOU ALSO KNOW THAT BASED ON THE INFORMATION THAT DANCETRANCER HAS BEEN KIND ENOUGH TO PROVIDE HERE ON THIS THREAD THAT MANY DOCTORS ARE IN A QUANDRAY AS TO WHAT KIND OF THERAPY TO SUGGEST  FOR THE SMALLEST OF SMALL HER2+ TUMORS BECAUSE THERE ARE NO FORTHCOMING TRIALS.

HERE ARE THE CURRENT CLINICAL TRIALS THAT ARE UNDERWAY INVOLVING CHEMO AND HERCEPTIN:

Herceptin trials in early breast cancer

This page tells you about research into using trastuzumab (Herceptin) for early breast cancer to try to stop the cancer from coming back. There is information about

What Herceptin is

Trastuzumab (Herceptin) is a biological cancer treatment. It is a monoclonal antibody that attaches to the HER2 protein found on the cells of some breast cancers. Cancers that are HER2 positive tend to have a worse outlook than cancers that are HER2 negative. If the cells of your cancer aren't HER2 positive, Herceptin won't help to treat it. Between 20 to 25 out of every 100 early breast cancers (20 to 25%) have the HER2 protein on their cells.

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Trial results for Herceptin in early breast cancer

3 large trials looked into using Herceptin to treat HER2 positive early breast cancer. They aimed to try to stop the cancer from coming back. Two of the trials were American and one is a very large European and worldwide trial called HERA. The trials looked at giving Herceptin as well as chemotherapy to women after surgery to remove their breast cancer. The researchers wanted to see whether the combined treatment could reduce the risk of breast cancer coming back even more than chemotherapy on its own. This type of treatment is called adjuvant therapy.

All the trials were for women who had breast cancer that tested positive for HER2. And most of them had cancer spread to their lymph nodes. This meant that the women had a high risk of their breast cancer coming back. In the trials the women either had Herceptin after their chemotherapy or at the same time. The trials showed that the cancer came back in about half as many women when compared to chemotherapy given without Herceptin. But we'll have to wait a few more years yet to get longer term results for all the women who took part.

A smaller fourth trial gave a short course of trastuzumab to women with lymph node-positive tumours or tumours bigger than 2 cm. The women had nine weekly infusions of trastuzumab with their chemotherapy. The risk of the cancer coming back and the risk of dying was significantly reduced in the women who had Herceptin.

It is important to know that Herceptin can cause heart problems in some women. This is more likely if you have had chemotherapy with a drug that also causes heart problems. Doxorubicin (adriamycin) is one such drug and it was used with Herceptin in the early breast cancer trials because it is particularly good at preventing breast cancer recurrence.

There are clinical trials looking at treating early breast cancer with Herceptin. There is a phase 3 trial called EPHOS B looking at the effect of having trastuzumab (Herceptin) or lapatinib before surgery. Research has shown that having Herceptin after surgery lowers the risk of the cancer coming back in people with HER2 positive breast cancer. The researchers want to find out if having drugs that work by blocking HER2 protein before surgery may lower the risk more.

Another phase 3 trial called SOLD is looking at having Herceptin with chemotherapy for early breast cancer. The aim of this trial is to compare having Herceptin with chemotherapy to the same treatment followed by continued Herceptin for one year.

There is another phase 3 trial called PERSEPHONE. This trial is comparing 6 months and 12 months of trastuzumab for early breast cancer. The aim of this trial is to find out if 6 months of treatment works as well as 12 months. As Herceptin can cause heart problems in some women, the researchers also want to find out if having treatment for a shorter time can help lower the risk of damage to the heart.

APHINITY is a phase 3 trial looking at Herceptin and pertuzumab for HER2 positive breast cancer. Pertuzumab is another monoclonal antibody that also targets the HER2 protein. The researchers want to find out if giving pertuzumab and Herceptin is better than Herceptin alone for people who have had surgery for HER2 positive breast cancer.

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What we don't know yet

Although Herceptin has been shown to reduce the chance of cancer coming back in women with HER 2 positive breast cancer, there are still some questions about how best to use Herceptin, such as

  • When is the best time to have Herceptin
  • How long to prescribe it for
  • Whether any long term risks of this treatment could outweigh the benefits for some women
  • Whether the treatment just delays the breast cancer coming back rather than preventing it altogether

To answer these questions, research into Herceptin for early breast cancer is continuing. For now, the National Institute for Health and Clinical Excellence (NICE) have said that doctors should give it 3 weekly for a year (after surgery, chemotherapy and radiotherapy has finished). They may revise this in future depending on new research results.

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More information about Herceptin for early breast cancer

There is detailed information about the NICE guidance on Herceptin for early breast cancer in the biological therapy for early breast cancer section.

You can find out more about Herceptin trials for breast cancer on our clinical trials database. Choose 'breast cancer' from the dropdown menu of cancer types and type 'trastuzumab' into the text box. If you want to see all the trials, tick the boxes for closed trials and trial results.

______________________________________________________________________

 AND HERE'S THE STUDY FOR THE OVER 70 POPULATION USING HERCEPTIN AS MONOTHERAPY:

Evaluation of Trastuzumab Without Chemotherapy as a Post-operative Adjuvant Therapy in HER2-positive Elderly Breast Cancer                  Patients: Randomized Controlled Trial [RESPECT (N-SAS BC07)]
  1. Masataka Sawaki1,*,                     
  2. Nahomi Tokudome2,                     
  3. Toshiro Mizuno3,                     
  4. Takahiro Nakayama4,                     
  5. Naruto Taira5,                     
  6. Hiroko Bando6,                     
  7. Shigeru Murakami7,                     
  8. Yutaka Yamamoto8,                     
  9. Masahiro Kashiwaba9,                     
  10. Hiroji Iwata10,                     
  11. Yukari Uemura11 and                     
  12. Yasuo Ohashi11

+ Author Affiliations

  1. 1Department of Clinical Oncology and Chemotherapy, Nagoya University Graduate School of Medicine, Nagoya
  2. 2Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo
  3. 3Department of Medical Oncology, Mie University Hospital, Tsu
  4. 4Department of Breast and Endocrine Surgery, Osaka University Hospital, Osaka
  5. 5Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama
  6. 6Department of Breast and Endocrine Surgery, Graduate School of Comprehensive Human Science, University of Tsukuba, Tsukuba
  7. 7Department of Breast Surgery, Hiroshima City Asa Hospital, Hiroshima
  8. 8Department of Breast and Endocrine Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto
  9. 9Department of Surgery, Iwate Medical University, Morioka
  10. 10Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya
  11. 11Department of Biostatistics, School of Public Health, University of Tokyo, Tokyo, Japan                       
  1. *For reprints and all correspondence: Masataka Sawaki, Department of Clinical Oncology and Chemotherapy, Nagoya University                        Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan. E-mail: m-sawaki@med.nagoya-u.ac.jp
  1. † An abstract was presented in part at 2010 Breast Cancer Symposium, Washington, DC, 1-3 October 2010.                       

  • Received November 2, 2010.                    
  • Accepted January 14, 2011.                    
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Abstract

Objective This trial is conducted to investigate the benefit of trastuzumab monotherapy compared with a combination therapy of trastuzumab                        and chemotherapy in women over 70 years with human epidermal growth factor receptor type-2-positive primary breast cancer.                    

Methods Inclusion criteria are the following: histologically diagnosed as invasive breast cancer and received curative operation                        for primary breast cancer; Stage I, IIA, IIB or IIIA/M0; and baseline left ventricular ejection fraction is ≥55%. Patients                        are randomized to receive either trastuzumab (8 mg/kg loading dose, 6 mg/kg every 3 weeks for 1 year) plus chemotherapy selected                        from regimens specified on the protocol or trastuzumab monotherapy. The primary endpoint is disease-free survival. Secondary                        endpoints are overall survival, relapse-free survival, safety, health-related quality of life, comprehensive geriatric assessment                        and cost effectiveness.                    

Results Patients recruitment has been commenced in October 2009. Enrollment of 300 patients is planned during the 4-year recruitment                        period.                    

Conclusions We hereby report the study concept.                    

Key words

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INTRODUCTION

Trastuzumab with chemotherapy is the standard treatment as an adjuvant systemic therapy for human epidermal growth factor                     receptor type-2 (HER2)-positive primary breast cancer (1-4). Overexpression of HER2 has also been associated with potentially more aggressive tumors; therefore, trastuzumab is a key                     drug in the treatment of HER2-positive primary cancer. However, monotherapy of trastuzumab as an adjuvant treatment without                     concurrent or preceding chemotherapy is not conducted in clinical practice since its benefit has not been investigated as                     well as elderly patients (5). It has clinical significance to demonstrate the benefit of trastuzumab monotherapy without toxicity induced by chemotherapy,                     especially in elderly patients. Chemotherapy is not always a standard therapy in elderly patients based on the analysis of                     Early Breast Cancer Trialists' Collaborative Group (EBCTCG) because of limited data (6). Careful monitoring is necessary for elderly patients due to toxicity, cardiac toxicity associated with anthracycline-containing                     chemotherapy (7,8), increasing in acute myeloid leukemia (AML) after adjuvant chemotherapy (9).                 

This trial is conducted to investigate the clinical positioning between trastuzumab monotherapy (H group) and a combination                     therapy of trastuzumab and chemotherapy (H + CT group) based on a randomized controlled trial in women over 70 years with                     HER2-positive primary breast cancer.                 

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DIGEST OF THE STUDY PROTOCOL

Purpose

This study is conducted to investigate the clinical positioning between trastuzumab (Herceptin) monotherapy (H group) and                        a combination therapy of trastuzumab and chemotherapy (H + CT group) based on a randomized controlled trial in women over                        70 years with HER2-positive primary breast cancer (Fig. 1). Our hypothesis includes the following two points:                                            

  • (i) H group is non-inferior to the H + CT group in disease-free survival (DFS).

  • (ii) H group is superior in safety and health-related quality of life (HRQOL).

Figure 1.View larger version:

Figure 1.

Study schema. Evaluation of trastuzumab without chemotherapy as a post-operative adjuvant therapy in HER2-positive elderly                                 breast cancer patients: randomized controlled trial [RESPECT (N-SAS BC07)].                             

HER2, human epidermal growth factor receptor type-2; IHC, immunohistochemistry; FISH, fluorescence in situ hybridization; PTX, paclitaxel; DTX, docetaxel; AC, doxorubicin and cyclophosphamide; EC, epirubicin and cyclophosphamide;                                 CMF, cyclophosphamide, methotrexate and 5-fluorouracil.                             

Study Setting

This study is a multi-institutional prospective randomized controlled trial with 56 participating centers as of 31 August                        2010.                    

Study Support

This study was funded by Comprehensive Support Project for Oncology Research (CSPOR) of Public Health Research Foundation.                        All decisions concerning the planning, implementation and publication of this study were made by the executive committee of                        this study.                    

Endpoints

The primary endpoint is DFS. Secondary endpoints are overall survival, relapse-free survival, adverse events, HRQOL, comprehensive                        geriatric assessment and cost-effectiveness analysis.                    

Eligibility Criteria

Inclusion Criteria

  • (i) Histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer.

  • (ii) Stage I [tumor size (pT) ≥1 cm), IIA, IIB or IIIA/M0; female between 70 and 80 years old.

  • (iii) Primary cancer is HER2-positive (either 3+ overexpression or positive by fluorescence in situ hybridization).                             

  • (iv) Baseline left ventricular ejection fraction is ≥55% measured by echocardiography or multigated acquisition scan within                                 4 weeks before registration.                             

  • (v) Performance status (PS) 0-1.

  • (vi) Sufficient organ function meeting the following criteria within 4 weeks before registration:                                                              

    • (a) Leukocyte ≥2500 mm3

    • (b) Neutrophil ≥1500 mm3

    • (c) Platelet ≥100 000 mm3

    • (d) Serum total bilirubin ≤2.0× the upper limit of normal (ULN)

    • (e) Alanine aminotransferase (glutamic pyruvic transaminase) or aspartate aminotransferase (glutamic oxaloacetic transaminase)                                       ≤2.5× ULN                                   

    • (f) Serum creatinine ≤2.0× ULN

    • (g) Alkaline phosphatase ≤2.5× ULN

  • (vii) No previous endocrine therapy or chemotherapy for breast cancer.

  • (viii) Signed written informed consent.

Exclusion Criteria

  • (i) Active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs).

  • (ii) Post-operative histological axillary lymph node metastasis ≥4.

  • (iii) Axillary lymph node is not histologically evaluated.

  • (iv) Histologically confirmed positive margin in breast conservation surgery (evaluation of margin status is based on the                                 policy of site).                             

  • (v) History of drug-related allergy which could hinder planned treatment.

  • (vi) Any history or complication of the following cardiac disorders.

  • (vii) History of congestive heart failure, cardiac infarction.

  • (viii) Complication requires treatment such as ischemic cardiac disorder, arrhythmia and valvular heart disease.

  • (ix) Poorly controlled hypertension (e.g. systolic arterial pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg).

  • (x) Poorly controlled diabetes.

  • (xi) Continuous visit to a medial institution is considered difficult due to deterioration of activity of daily living.

  • (xii) Difficult to participate in the trial because of psychiatric disorder or psychiatric symptoms.

  • (xiii) Ineligible to the trial based on the decision of an investigator.

Patient Assignment

The CSPOR Data Center will confirm patient eligibility, and treatment will be automatically assigned according to the assignment                        adjustment factors for eligible patients. The following five variables will be used as assignment adjustment factors: age                        (70-75/76-80), PS (0/1), hormone sensitivity, lymph node metastasis and hospital.                    

Treatment

Combination Therapy of Trastuzumab and Chemotherapy Arm

The loading administration dose of trastuzumab is 8 mg/kg of body weight, and the maintenance dose is 6 mg/kg every 3 weeks                           for 1 year. Chemotherapy is selected from regimens specified on the protocol based on the decision of a physician or a patient.                                                  

  • (i) Paclitaxel (PTX) 80 mg/m2 weekly administered every week for 11 cycles.                             

  • (ii) Docetaxel (DTX) 75 mg/m2 every 3 weeks for four cycles.                             

  • (iii) Doxorubicin (A) 60 mg/m2 and cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles.                             

  • (iv) Epirubicin (E) 90 mg/m2 and cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles.                             

  • (v) Cyclophosphamide (C) 75-100 mg orally from days 1 to 14, methotrexate (M) 40 mg/m2 on days 1 and 8 intravenously, and 5-fluorouracil (F) 500-600 mg/m2 intravenously on days 1 and 8, every 4 weeks for six cycles.                             

Administration of trastuzumab initiates after completion of chemotherapy as a sequential combination. However, concomitant                           administration is allowed when combining trastuzumab with PTX, DTX and CMF.                       

If the hormone receptor is positive, hormone therapy is indicated. In the case of after breast conservative operation, irradiation                           for breast is indicated after chemotherapy.                       

Trastuzumab Monotherapy Arm

The loading dose of trastuzumab is 8 mg/kg of body weight, and the maintenance dose is 6 mg/kg every 3 weeks for 1 year.

If hormone receptor is positive, hormone therapy is indicated. In case of after breast conservative operation, irradiation                           for breast is indicated after surgery or concurrent with trastuzumab.                       

Stratification Factors

  • (i) Age at registration: 70-75/76-80

  • (ii) PS: 0/1

  • (iii) Hormone receptor status: positive/negative

  • (iv) Pathological nodal status: positive/negative

  • (v) Institution

Statistical Analysis

Main Analysis and Assessment Criteria

To evaluate the clinical position of each treatment, the estimated hazard ratio is compared with a threshold hazard ratio                           of 1.69. Concretely, the threshold will be used to determine whether the H + CT group is equivalent (not inferior) to the                           H group with regard to DFS. As an aid to interpret the trial result, we will estimate the three posterior probabilities between                           and outside the following two thresholds: ‘the upper threshold of hazard ratio (1.69) to select the combination therapy of                           trastuzumab and chemotherapy' and ‘the lower threshold (1.22) to select the monotherapy of trastuzumab', using the posterior                           distribution of log hazard ratio based on a non-informative prior.                       

Sample Size and Follow-up Period

The primary endpoint will require 120 events in total, given a power of 80% and a threshold hazard ratio of 1.69. Giving that                           the 3-year DFS probability in the study population is 68% and assuming that the survival time follows the exponential distribution,                           a total of 260 patients will be necessary for 3 years of follow-up after 4 years of registration to assess the 120 events.                           Therefore, the target number of registration was determined to be 300 since exponential distribution of survival might not                           be shown because of the elderly population and dropout patients were expected.                       

This study has been started from October 2009 and completion is scheduled in October 2016 with a registration period for 4                           years and a follow-up period for 3 years.                       

Registration of the Protocol

The protocol was registered at the website of the University Hospital Medical Information Network (UMIN), Japan (protocol                        ID UMIN000002349), on 1 September 2009. Details are available at the following address: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000002854&language=E.                    

And also registered at ClinicalTrials.gov (protocol ID NCT01104935), on 6 November 2009. Details are available at the following address: http://clinicaltrials.gov/show/NCT01104935NCT01104935.                    

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Funding

This study is supported by the Public Health Research Foundation, Japan. The corporate and individual sponsors of this study                     are listed on the CSPOR website (http://www.csp.or.jp/cspor/kyousan_e.html).                 

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Conflict of interest statement

Hiroji Iwata and Yasuo Ohashi receive honoraria for speaking events from Chugai Pharmaceutical Co., Ltd.

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References

    1. Romond EH,
    2. Perez EA,
    3. Bryant J,
    4. Suman VJ,
    5. Geyer CE Jr.,
    6. Davidson NE,
    7. et al
    . Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 2005;353:1673-84.CrossRefMedlineWeb of Science
    1. Piccart-Gebhart MJ,
    2. Procter M,
    3. Leyland-Jones B,
    4. Goldhirsch A,
    5. Untch M,
    6. Smith I,
    7. et al
    . Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005;353:1659-72.CrossRefMedlineWeb of Science
    1. Slamon D,
    2. Eiermann W,
    3. Robert N,
    4. Pienkowski T,
    5. Martin M,
    6. Pawlicki M,
    7. et al
    . Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC → T) with doxorubicin and                                    cyclophosphamide followed by docetaxel and trastuzumab (AC → TH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2                                    positive early breast cancer patients: BCIRG 006 study. Breast Cancer Res Treat 2005;94:S5.
    1. Smith I,
    2. Procter M,
    3. Gelber RD,
    4. Guillaume S,
    5. Feyereislova A,
    6. Dowsett M,
    7. et al
    . 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet 2007;369:29-36.CrossRefMedline
    1. Jahanzeb M
    . Adjuvant trastuzumab therapy for HER2-positive breast cancer. Clin Breast Cancer 2008;8:324-33.CrossRefMedlineWeb of Science
  1. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the                                    randomised trials. Lancet 2005;365:1687-717.CrossRefMedlineWeb of Science
    1. Pinder MC,
    2. Duan Z,
    3. Goodwin JS,
    4. Hortobagyi GN,
    5. Giordano SH
    . Congestive heart failure in older women treated with adjuvant anthracycline chemotherapy for breast cancer. J Clin Oncol 2007;25:3808-15.Abstract/FREE Full Text
    1. Du XL,
    2. Xia R,
    3. Liu CC,
    4. Cormier JN,
    5. Xing Y,
    6. Hardy D,
    7. et al
    . Cardiac toxicity associated with anthracycline-containing chemotherapy in older women with breast cancer. Cancer 2009;115:5296-308.CrossRefMedlineWeb of Science
    1. Patt DA,
    2. Duan Z,
    3. Fang S,
    4. Hortobagyi GN,
    5. Giordano SH
    . Acute myeloid leukemia after adjuvant breast cancer therapy in older women: understanding risk. J Clin Oncol 2007;25:3871-6.Abstract/FREE Full Text
Doctor told me regarding my prognosis that I WASN'T on the Titanic! Hmmm...Really?....Okay! 02/2010 Pure Mucinous Breast Cancer, Oncotype DX 15, Stage 1, Grade 1, 1.8 cm, 0/2 nodes, ER+ 90% /PR+ 70% HER2- (+1)
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Apr 10, 2012 07:45AM voraciousreader wrote:

For any "newbie" reading this, I wish to make clear that the question that Alaska Angel is asking is VERY deceptive.  She asks vjm, "Could you post the adjuvant studies that demonstrate that "chemo seems to bump up the effectiveness of herceptin"?

I wish to make clear that THERE ARE NO STUDIES THAT DEMONSTRATE THAT CHEMO BUMPS UP THE EFFECTIVENESS OF HERCEPTIN because there has NEVER been a trial of HERCEPTIN ALONE....that is until now.... with this group of patients over the age of 70.

For AA to ask this question of vjm is disingenuous because SHE KNOWS that the question she posed can NOT be answered at this time, nor is an answer forthcoming soon.

Doctor told me regarding my prognosis that I WASN'T on the Titanic! Hmmm...Really?....Okay! 02/2010 Pure Mucinous Breast Cancer, Oncotype DX 15, Stage 1, Grade 1, 1.8 cm, 0/2 nodes, ER+ 90% /PR+ 70% HER2- (+1)
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Apr 10, 2012 07:50AM suzieq60 wrote:

There have been trials of having herceptin following chemo and they did show that giving it concurrently improved the results.

Hey VR - what's with the large font - too funny - longest post I've ever seen :)

2nd diagnosis October 2010 - IDC 5.8mm node negative - missed on mammogram in October 2009 Dx 10/13/2009, ILC, 1cm, Stage I, Grade 3, 0/5 nodes, ER+/PR+, HER2+
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Apr 10, 2012 07:58AM voraciousreader wrote:

You are correct Susie.  Giving the Herceptin at the same time of chemo, rather than after completion of chemo does improve survival.  But that's NOT what AA is asking.  She's asking for data that proves the combination of Herceptin WITH chemo improves survival.  And the only way we would know that with certainty is by having a clinical trial of comparing Herceptin MONOTHERAPY to Herceptin WITH chemo.  And we don't know the answer to that question because the bottom line is that the standard of care is GIVING BOTH MEDS.  Alaska Angel knows that.

And I didn't get my capital letters stuck.  I was yelling.  Time to check my blood pressure now.

Doctor told me regarding my prognosis that I WASN'T on the Titanic! Hmmm...Really?....Okay! 02/2010 Pure Mucinous Breast Cancer, Oncotype DX 15, Stage 1, Grade 1, 1.8 cm, 0/2 nodes, ER+ 90% /PR+ 70% HER2- (+1)
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Apr 10, 2012 08:02AM suzieq60 wrote:

VR - I wasn't referring to your capitals - but the study at the end in very big font.

2nd diagnosis October 2010 - IDC 5.8mm node negative - missed on mammogram in October 2009 Dx 10/13/2009, ILC, 1cm, Stage I, Grade 3, 0/5 nodes, ER+/PR+, HER2+
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Apr 10, 2012 08:05AM voraciousreader wrote:

I know....That's cut and paste for you....It changed the font...not me.  But I was yelling!

Meanwhile, I wholeheartedly agree, that based on the current evidence, the combination of Herceptin AND chemo is compelling.

Doctor told me regarding my prognosis that I WASN'T on the Titanic! Hmmm...Really?....Okay! 02/2010 Pure Mucinous Breast Cancer, Oncotype DX 15, Stage 1, Grade 1, 1.8 cm, 0/2 nodes, ER+ 90% /PR+ 70% HER2- (+1)
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Apr 10, 2012 10:14AM vjm wrote:

Morning Dancetrancer - thinking of you on this day:)

vjm

Dx 10/28/2011, IDC, <1cm, Stage IA, Grade 3, 0/2 nodes, ER+/PR+, HER2+ Surgery 11/29/2011 Lumpectomy: Right Surgery 12/28/2011 Lumpectomy: Right; Lymph node removal: Right, Sentinel Radiation Therapy 3/12/2012 Breast Targeted Therapy 4/13/2012 Herceptin (trastuzumab) Chemotherapy 4/13/2012 Cytoxan (cyclophosphamide), Taxotere (docetaxel) Hormonal Therapy
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Apr 10, 2012 10:58AM chachamom wrote:

Thanks vjm. I'm one that NEVER IMAGINED I would EVER take an anti-depressant.....but right now I-m very grateful for the PROZAC prescribed by my PM...... And thanks voraciousreader for posting that information for us " newbies". BTW: my name is Jill and I'll try to update my profile when I get my final pathology report on Thursday.
Jill

Jill. Age 59. "Life is a shipwreck, but we must not forget to sing in the lifeboats." - Voltaire. No chemo/herceptin and no radiation because the largest of multi focal tumors was 3mm Dx 3/12/2012, IDC, <1cm, Stage IA, Grade 2, 0/5 nodes, ER+/PR+, HER2+ Hormonal Therapy 5/30/2012
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Apr 10, 2012 11:36AM - edited Apr 10, 2012 11:37AM by AlaskaAngel

My post asked for clarification. I didn't throw in any curves. It is an honest question. Sometimes the manner or the words used by which a patient is told information can be both confusing and misleading. The information is complicated, and there is a lot to take in at the time a person is discussing diagnosis and treatment. That seems to be the case over and over about what actual evidence has been acquired thus far about the comparative effect of these treatments.

Those who have a strong preference favoring the addition of chemotherapy do not point out the actual difference when other patients quite innocently assume and make the claim that chemo seems to improve the effectiveness of Herceptin.

People should choose whatever treatment is available that they feel they benefit from. I don't see any reason for all those who are in the process of making the choice not to be given the information that for supposedly "ethical" reasons, there has been no definitive adjuvant comparison use of Herceptin used alone vs Herceptin with chemotherapy.

So it remains a responsibility to not influence others to believe that there is definite evidence proving that "Herceptin and chemo have been proven to be better than Herceptin used alone."  That has not been proven. What has been proven is that "chemo plus Herceptin works better than chemo used alone.

If anyone feels defensive about making that distinction clear and favors the addition of chemo strongly enough to yell and make accusations about the reasons for someone like me to continue to point out the mistaken impression that is created and fostered by that bias, then patients should know that problem exists. It may well be that sometime down the road it will be proven that chemo plus X is better than X alone.  Right now all they have proven is that chemo plus X is better than chemo alone. What we don't know is what the long and short-term negative effects of adding chemo (such as on the immune system) are for early stage patients in comparison to using Herceptin without chemo (allowing a stronger immune system response to assist). Again, each of us is welcome to make our own decisions about treatment preferences. AlaskaAngel
Dx 12/3/2001, DCIS/IDC, Left, 1cm, Stage IA, Grade 3, 0/1 nodes, ER+/PR+, HER2+ (IHC) Surgery 1/2/2002 Lumpectomy: Left; Lymph node removal: Left, Sentinel Chemotherapy 3/11/2002 Adriamycin (doxorubicin), Cytoxan (cyclophosphamide), Fluorouracil (5-fluorouracil, 5-FU, Adrucil) Radiation Therapy 9/9/2002 Breast Hormonal Therapy 11/14/2002 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Apr 10, 2012 01:16PM - edited Apr 10, 2012 01:17PM by voraciousreader

Alaska Angel... I regret that you choose to go down a slippery path of smoke and mirrors. There needs to be NO clarification whatsoever. You knew the answer to the loaded question that you asked. Shame on you. You could have been forthright... But chose instead to be deceptive.

Doctor told me regarding my prognosis that I WASN'T on the Titanic! Hmmm...Really?....Okay! 02/2010 Pure Mucinous Breast Cancer, Oncotype DX 15, Stage 1, Grade 1, 1.8 cm, 0/2 nodes, ER+ 90% /PR+ 70% HER2- (+1)
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Apr 10, 2012 06:41PM vjm wrote:

Chachamom - In British Columbia I cannot get Herceptin alone as it is not funded that way. My choice was to either have both or none. I am choosing both. vjm

Dx 10/28/2011, IDC, <1cm, Stage IA, Grade 3, 0/2 nodes, ER+/PR+, HER2+ Surgery 11/29/2011 Lumpectomy: Right Surgery 12/28/2011 Lumpectomy: Right; Lymph node removal: Right, Sentinel Radiation Therapy 3/12/2012 Breast Targeted Therapy 4/13/2012 Herceptin (trastuzumab) Chemotherapy 4/13/2012 Cytoxan (cyclophosphamide), Taxotere (docetaxel) Hormonal Therapy
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Apr 10, 2012 07:40PM dancetrancer wrote:

Hi everyone!  I made it through today with flying colors!!!  I did my cold caps all day which went very well, and had NO allergic reactions whatsoever!!!  I'm thrilled!  I just did the Taxotere and Carboplatin today - doc infused very slowly with lots of fluids and premeds to try to prevent allergic reactions.  I will have the Herceptin tomorrow with more premeds and slow adminstration for the same reason.  If I continue to do well they may move it all faster and into one day like it is standardly done.  For now, I am happy to go the slow and safe approach, given my allergic reaction history. Smile  Thrilled to be done with one day!  

The worst part of the day was trying to make myself ice my toes and fingers to prevent nail issues and chew on ice to try to reduce mouth sores.  I was soooooooooo cold!  I just couldn't keep my fingers in the ice the entire time.  I still think it's better than nothing!  I was very, very happy I had brought lots of warm clothes and my electric blanket and heating pad!

As far as the discussion here, thank you VR for making all of the salient points that I would have regarding the research that is out there!!!  The evidence we do have is compelling enough for me to choose this path.  And my doc at MD Anderson was the icing on the cake for me.  I'm not playing around with a HER2+ cancer, no matter no small it is.  Give me the big guns and the best chance at a long, long life! 

Cold caps work! coldcapphotos.shutterfly.com/p... TCH: 4/10 - 6/13/12; 33 rads; BMX w/fat grafting; DX: 7/29/11 @ age 43: Stage 1A on L (3 mm IDC w/ 6 cm DCIS, Gr 2 ER/PR+, HER2+) 0/3 nodes; Stage 0 on R (2 mm DCIS); see bio.
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Apr 10, 2012 08:01PM lago wrote:

Dance so happy things went so smoothly for you. I hope this continues throughout the week.
DONE!! goo.gl/IoaN6U • Tattoos 2.7.2012 • Nipples 10.6.2011 • Exchange 6.24.2011 • Chemo 1.18. 2011 • BMX 8.31.2010 Dx 7/13/2010, IDC, 5cm, Stage IIB, Grade 3, 0/14 nodes, ER+/PR+, HER2+
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Apr 10, 2012 09:06PM fluffqueen01 wrote:

Hey Dance....when I started the hot flashes, I was really wishing that I had the cold caps going. Until I started effexor a couple weeks ago, there were nights when I stuck one of thos blue ice bags on my head to get to sleep.

Chacha...my name is Jill too!

BMX 2/10 w/TE Taxol 12 wkly/herceptin- 1 yr/ Tamoxifen now. TE’s fail/TE’s back in.  Implants 11/11- perky!" tatoo touchup remains. Be kind, for everyone you meet is fighting a hard battle. Plato Targeted Therapy 3/13/2011 Herceptin (trastuzumab)
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Apr 10, 2012 09:10PM Moonflwr912 wrote:

Yay, dance. First one done, now you are on the way to finishing!

Sometimes life SUCKS! Sometimes it doesn't. I prefer when it doesn't! If you're ever bored, read my biography. Bring snacks..... LOL Monica Dx 11/11/2011, DCIS, Right, 1cm, Stage 0, Grade 3, 0/2 nodes, ER+/PR+, HER2+ (FISH) Surgery 12/7/2011 Mastectomy: Right; Prophylactic mastectomy: Left; Reconstruction (left): Tissue expander placement; Reconstruction (right): Tissue expander placement Dx 12/8/2011, IDC, 1cm, Stage IA, Grade 3, 0/2 nodes, ER+/PR+, HER2+ Surgery 1/16/2012 Reconstruction (left) Targeted Therapy 2/15/2012 Herceptin (trastuzumab) Chemotherapy 2/15/2012 Carboplatin (Paraplatin), Taxotere (docetaxel) Surgery 8/12/2012 Reconstruction (left): Tissue expander placement Hormonal Therapy 8/19/2012 Arimidex (anastrozole) Surgery 9/9/2012 Reconstruction (left) Surgery 8/13/2013 Reconstruction (left): Tissue expander placement Surgery 9/3/2013 Reconstruction (left) Surgery 12/12/2013 Reconstruction (left): Saline implant; Reconstruction (right): Saline implant
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Apr 10, 2012 10:43PM voraciousreader wrote:

Dancetrancer... I wish you and all the other sisters here well who are beginning this latest chapter in active treatment.

Doctor told me regarding my prognosis that I WASN'T on the Titanic! Hmmm...Really?....Okay! 02/2010 Pure Mucinous Breast Cancer, Oncotype DX 15, Stage 1, Grade 1, 1.8 cm, 0/2 nodes, ER+ 90% /PR+ 70% HER2- (+1)
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Apr 10, 2012 11:26PM cookiegal wrote:

DT...I am always reading the threads of women who face tough decisions. I have been following your ups and downs. I am glad chemo #1 went so well.
You deserve a cookie!
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Apr 11, 2012 05:45AM suzieq60 wrote:

dancetrancer - great news you got through the first tx. My onc didn't give me herceptin until the second treatment so he could watch for reactions. Make sure you call your onc if you have any SE's - one from taxotere could be leg pain a couple of days after. Claratyne and a prescription pain killer fixes it. Hope you were given Emend too - all the best and hoping for minimal problems for you.

((((((((((((HUGS)))))))))))))

Sue

2nd diagnosis October 2010 - IDC 5.8mm node negative - missed on mammogram in October 2009 Dx 10/13/2009, ILC, 1cm, Stage I, Grade 3, 0/5 nodes, ER+/PR+, HER2+
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Apr 11, 2012 07:08AM Sugar77 wrote:

Dance - I know it s gets pretty cold with the ice on your toes and fingers (...and chomping for throat) but try to keep on as long as you can.  I did take mine off the ice intermittently and but since they were on ice for most of the time, I didn't have any problems at all. In fact, my nails never looked better :) lol

Glad to hear your first treatment went well. 

Surgery 9/24/2009 Lumpectomy: Right Dx 10/27/2009, IDC, Right, <1cm, Stage IA, Grade 3, 0/2 nodes, ER-/PR-, HER2- Chemotherapy 12/6/2009 Cytoxan (cyclophosphamide), Taxotere (docetaxel) Dx 12/5/2019, IDC, Right, 3cm, Stage IIA, Grade 2, 0/3 nodes, ER+/PR+, HER2- Surgery 1/26/2020 Mastectomy: Left, Right; Reconstruction (left): Tissue expander placement; Reconstruction (right): Tissue expander placement Chemotherapy 4/2/2020 Cytoxan (cyclophosphamide), Taxotere (docetaxel) Radiation Therapy Whole-breast: Breast Hormonal Therapy Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Apr 11, 2012 01:32PM chachamom wrote:

Fluff queen! So you're a Jill too? That's pretty cool!

Dance tracer: good news! I'm in your corner too! You are such a plosives inspiration! I'm going to a Image Reborn class tonight to hear about the options of reconstruction. I know it's really premature but it gives me something to look forward to.

Jill. Age 59. "Life is a shipwreck, but we must not forget to sing in the lifeboats." - Voltaire. No chemo/herceptin and no radiation because the largest of multi focal tumors was 3mm Dx 3/12/2012, IDC, <1cm, Stage IA, Grade 2, 0/5 nodes, ER+/PR+, HER2+ Hormonal Therapy 5/30/2012
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Apr 11, 2012 02:24PM AlaskaAngel wrote:

Dancetrancer,

Sounds like you are on a roll! Glad to hear your initial experience was so positive, and that you had no adverse reaction.

When chemo is used alone I understand that it generally provides some initial protection to about 20% of those who receive it, perhaps in part limited because it is not considered to be effective for stem cells. The trastuzumab provides protection for about 50% initially, and hopefully long-term for many. Your early diagnosis should be a plus.

I think it is quite a relief to move forward with treatment no matter what treatment one chooses.

AlaskaAngel

Dx 12/3/2001, DCIS/IDC, Left, 1cm, Stage IA, Grade 3, 0/1 nodes, ER+/PR+, HER2+ (IHC) Surgery 1/2/2002 Lumpectomy: Left; Lymph node removal: Left, Sentinel Chemotherapy 3/11/2002 Adriamycin (doxorubicin), Cytoxan (cyclophosphamide), Fluorouracil (5-fluorouracil, 5-FU, Adrucil) Radiation Therapy 9/9/2002 Breast Hormonal Therapy 11/14/2002 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Apr 11, 2012 02:41PM lago wrote:

AlaskaAngel the statistic(s) on how well chemo will work is best noted when looking at the individual. For some its 20% other it's less or more. The one blanket number isn't very valuable information. Also when combined with endocrine therapy (for hormone positive) it's even more effective according to the information my onc gave me bases on my diagnosis.

DONE!! goo.gl/IoaN6U • Tattoos 2.7.2012 • Nipples 10.6.2011 • Exchange 6.24.2011 • Chemo 1.18. 2011 • BMX 8.31.2010 Dx 7/13/2010, IDC, 5cm, Stage IIB, Grade 3, 0/14 nodes, ER+/PR+, HER2+
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Apr 11, 2012 02:51PM AlaskaAngel wrote:

Hi lago,

The numbers are general but we are not, and we hope for the best. Not all are able to tolerate the endocrine therapy, but it certainly improves the picture for many. The decision-making is a very difficult time for good reasons.

A.A.

Dx 12/3/2001, DCIS/IDC, Left, 1cm, Stage IA, Grade 3, 0/1 nodes, ER+/PR+, HER2+ (IHC) Surgery 1/2/2002 Lumpectomy: Left; Lymph node removal: Left, Sentinel Chemotherapy 3/11/2002 Adriamycin (doxorubicin), Cytoxan (cyclophosphamide), Fluorouracil (5-fluorouracil, 5-FU, Adrucil) Radiation Therapy 9/9/2002 Breast Hormonal Therapy 11/14/2002 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)

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