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Old 06-18-2008, 05:51 PM   #1
Joe
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ALTTO Trial - Herceptin / Tykerb

New Study of Targeted Therapies for Breast Cancer Establishes Model for Global Clinical Trials
Two targeted medications designed to treat an aggressive form of breast cancer are being tested in a new study involving 8,000 participants in 50 countries across six continents -- a clinical trial that investigators hope will provide a new model for global cancer research.

This trial, dubbed ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization study), will be one of the first global initiatives in which two large, academic breast cancer research networks covering different parts of the world have jointly developed a study in which all care and data collection are standardized, regardless of where patients are treated. The networks are The Breast Cancer Intergroup of North America (TBCI), based in the United States, and the Breast International Group (BIG) in Brussels, Belgium. TBCI consists of six National Cancer Institute (NCI)-funded clinical trials cooperative groups. NCI is part of the National Institutes of Health.

ALTTO is designed to answer the most pressing questions regarding use of two widely used cancer agents: whether one agent is more effective, which agent is safer for patients, and what benefit will be derived by taking the drugs separately, in tandem order, or together? The trial is a randomized, Phase III study, which is considered a gold standard method for proving drug effectiveness.

The two agents tested in ALTTO are drugs designed to treat HER2-positive tumors, which is a particularly aggressive form of cancer that affects approximately 20 percent to 25 percent of breast cancer patients. Both agents, trastuzumab (Herceptin) and lapatinib (Tykerb), have already been approved by the U.S. Food and Drug Administration for use for treatment of HER2-positive breast cancer. ALTTO will provide the first head-to-head comparison of trastuzumab and lapatinib in the earliest, most treatable stages of cancer. It will also be one of the first large-scale studies to evaluate lapatinib's effectiveness in treating early breast cancer.
HER2-positive breast cancer is caused by an excess of HER2 genes or by over-production of its protein, the HER2 cell surface receptor. Trastuzumab consists of large antibodies that once injected into patients, latch on to the portion of the HER2 protein that sits on the outer surface of the cancer cell whereas lapatinib acts by entering a cancer cell and binding to the part of the HER2 protein that lies beneath the surface of the cell.
The trial is unusual in that it has two different designs depending on whether patients with stage I or stage II breast cancer have already been treated with chemotherapy. The study thus will compare four different regimens of targeted therapy administered over a 52-week period. Patients will be randomized to receive either trastuzumab or lapatinib alone, or trastuzumab followed by lapatinib, or the two treatments in combination.

"There have been major improvements in the management of patients with early breast cancer in the last few years, so this new study builds on this knowledge and sets an example of the new era: good science, good worldwide collaboration," said Edith Perez, M.D., an oncologist in the North Central Cancer Treatment Group (NCCTG) at Mayo Clinic in Jacksonville, Fla., who will lead the study for TBCI. "It may be that using two treatments that work in different ways against HER2-positive breast cancer offers a complementary strategy that is more powerful than either drug alone."

ALTTO will be one of the first trials of its scope in which translational research -- taking science from bench to bedside -- plays a critical role, investigators say. In ALTTO, biological material will be collected from thousands of patients in order to determine a tumor profile that responds best to the drugs -- information that could lead to individualized patient care and, possibly, to development of next generation agents.
"The difference between this study and many that came before it is that the collection of biological materials occurs as the trial is being conducted, not as an afterthought. While there are exceptions, not many companies or organizations have been willing to invest in that kind of research before," said Martine J. Piccart, M.D., Ph.D., professor of oncology at the Université Libre de Bruxelles, Belgium, and lead investigator for BIG, which she founded in 1996. "Now we have the chance to optimize therapy with powerful drugs in order to provide the best treatment possible for each of our patients."

Perez and Piccart led the development team of the ALTTO trial and will act as the study's co-principal investigators. On behalf of BIG and TBCI, these two lead investigators have been working toward collaborative clinical studies for a number of years. The ALTTO study, they say, represents a new paradigm that blends the high standards of both systems in order to test the latest breast cancer treatments as efficiently as possible in thousands of women worldwide.

"The NCI greatly appreciates the work that Mayo Clinic, TBCI and BIG are doing to help advance our understanding of the complex mechanisms that underlie different types of breast cancer," said Jo Anne Zujewski, M.D., a senior investigator in the clinical investigations branch at NCI. "We hope that this model of international collaboration is one which we can build upon in the future."

Lapatinib, in combination with the chemotherapy drug capecitabine, was approved by the U.S. Food and Drug Administration in March 2007 for the treatment of advanced or metastatic HER2-positive breast cancer in patients who had received prior therapy with three agents -- an anthracycline, a taxane and Herceptin. GlaxoSmithKline is providing the study drug, as well as additional financial support for the ALTTO trial. All drugs carry potential side effects, and more information of side effects for lapatinib and trastuzumab can be found in the Q&A at http://www.cancer.gov/newscenter/pre...ses/ALTTOQandA. NCI and GSK also provided comment and input on the design of the study.

NCCTG will act as the treatment base for ALTTO in North America. BIG is a network of 41 non-U.S. research groups from around the world. Its Brussels-based BrEAST Data Center is providing centralized data management for the global study (including the United States). The other members of TBCI include the Eastern Cooperative Oncology Group (ECOG), the Cancer and Leukemia Group B (CALGB), the Southwest Oncology Group (SWOG), the American College of Surgeons Oncology Group (ACOSOG), and the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG).
To date, more than 300 centers around the world have enrolled patients into ALTTO. Full enrollment is expected to involve about 500 centers in the United States and more than 800 centers in Europe and the rest of the world. A complete listing of ALTTO participating sites can be found by searching for ALTTO at http://www.cancer.gov/clinicaltrials/EGF106708.


# # #


A Science Writer's seminar on International Breast Cancer Trials and ALTTO took place on Friday, February 29, 2008 in New York City. To view an archived Webcast of the event, go to http://videocast.nih.gov/PastEvents.asp?c=4.
For Broadcasters: Video soundbites from the lead investigators are available through Pathfire's Digital Media Gateway (DMG) or on the Web at <A href="http://www.thenewsmarket.com/nci">www.TheNewsMarket.com/nci.
For a Q&A on this trial, please go to http://www.cancer.gov/newscenter/pre...ses/ALTTOQandA.
For Spanish translations of the press release and Q&A, please go to http://www.cancer.gov/espanol/notici...SpanishRelease.
For more info on BIG, please go to http://www.breastinternationalgroup.org.
For more info on Mayo, please go to http://clinicaltrials.mayo.edu or contact the Mayo Clinic Cancer Center Clinical Trials Referral Office at 507-538-7623.
For more information about cancer, visit http://www.cancer.gov, or call NCI's Cancer Information Service at 1-800-4 CANCER.
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Old 09-28-2008, 02:11 PM   #2
Jackie07
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ALTTO Trial

Hi,

A new member(Lisa) was asking about the ALTTO Trial and wanted to find other members who are also on it. I saw the posting by Maripausa (?) and wondered if reviving this thread would garnar more response.

Please reply to this thread if you are on the ALTTO Trial or know someone who is. Thank you.
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Old 03-13-2010, 03:32 AM   #3
Wetherby44
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Re: ALTTO Trial - Herceptin / Tykerb

The Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation study, or ALTTO, is an international, phase III clinical trial of two targeted therapies for HER2-positive breast cancer. HER2 is a protein found in high levels on up to 25 percent of all breast cancers. Tumors that overproduce HER2 tend to be more aggressive and more likely to recur than those that do not.
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Old 05-30-2010, 06:44 AM   #4
Lena59
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Post Re: ALTTO Trial - Herceptin / Tykerb

Dear all,
I am taking part in the medical study comparing Herceptin + Xyloda vs Herceptin + Tyverb. I have finished one cycle (3 months) and scans revealed that 2 of 5 mets in lungs have shrunk and the other 3 are stable
I started on a dose of 4150 mg Xyloda but side effects were too severe; swollen dry hands, blisters under my feet, blisters in my mouth... After another try with 3150 I am now on 2150 mg and allthough it is tuff I think I can manage the two weeks this time.
I have no severe side effects from Herceptin, (which was given to me for one year when first treated for BC in 2008) but Xyloda is tuff. It makes me really tired and lethargic, I get sad and very sensitive after just a few days into the cycle. I have considered quitting the study - and Xeloda - a few times as I just can't bear to take it, but since results show it is effective I keep taking it and now only 2 more days of these 2 weeks, then one whole week's break - yes! My psychologist has said it is not uncommon to have these depressions due to Xeloda. I think it is good to be prepared for that and to realize that it really is due to the medication. I feel really strong and positive while having the break from it! I am starting taking anti depressants now to balance the ups and downs...
All the best to you all!
Lena
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Old 07-21-2010, 02:09 PM   #5
ksrachel
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Red face Re: ALTTO Trial - Herceptin / Tykerb

I start this trial on Monday, July 26, 2010. I got word today that I am in the group that will get a year of Tykerb with no Herceptin, which is a little scary.

I have IDC, with negative sentinel node biopsy, tumor size 1.8 cm. I had a lumpectomy and re-excision with clean margins. This makes it a Stage 1 cancer.

I am PR+ ER+ and Her2neu+++, with a Bloom Richardson cell grade of 3 (score of 8 of 9).


The other thing that is a little scary is that it appears that Tykerb is harder on your liver than Hrceptin. I have non-alcohol related fatty liver, with AST 37 and ALT 61. (I know those are a little high, but do not really know how high, risks, etc...)

I have "chemo class" tomorrow and will be able to talk to the clinical trials coordinator and oncologist then and may get some more information. Any insight appreciated. I was delighted to find this thread.


--
Rachel

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Old 07-24-2010, 06:35 AM   #6
Jackie07
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Re: ALTTO Trial - Herceptin / Tykerb

Lena and Rachel,

Thanks for the information. Please take good care of yourselves during the trial and keep us updated.

Best wishes,
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NICU 4.4 LB
Erythema Nodosum 85
Life-long Central Neurocytoma 4x5x6.5 cm 23 hrs 62090 semi-coma 10 d PT OT ST 30 d
3 Infertility tmts 99 > 3 u. fibroids > Pills
CN 3 GKRS 52301
IDC 1.2 cm Her2 +++ ER 5% R. Lmptmy SLNB+1 71703 6 FEC 33 R Tamoxifen
Recc IIB 2.5 cm Bi-L Mast 61407 2/9 nds PET
6 TCH Cellulitis - Lymphedema - compression sleeve & glove
H w x 4 MUGA 51 D, J 49 M
Diastasis recti
Tamoxifen B. scan
Irrtbl bowel 1'09
Colonoscopy 313
BRCA1 V1247I
hptc hemangioma
Vertigo
GI - > yogurt
hysterectomy/oophorectomy 011410
Exemestane 25 mg tab 102912 ~ 101016 stopped due to r. hip/l.thigh pain after long walk
DEXA 1/13
1-2016 lesions in liver largest 9mm & 1.3 cm onco. says not cancer.
3-11 Appendectomy - visually O.K., a lot of puss. Final path result - not cancer.
Start Vitamin D3 and Calcium supplement (600mg x2)
10-10 Stopped Exemestane due to r. hip/l.thigh pain OKed by Onco 11-08-2016
7-23-2018 9 mm groundglass nodule within the right lower lobe with indolent behavior. Due to possible adenocarcinoma, Recommend annual surveilence.
7-10-2019 CT to check lung nodule.
1-10-2020 8mm stable nodule on R Lung, two 6mm new ones on L Lung, a possible lymph node involvement in inter fissule.
"I WANT TO BE AN OUTRAGEOUS OLD WOMAN WHO NEVER GETS CALLED AN OLD LADY. I WANT TO GET SHARP EDGED & EARTH COLORED, TILL I FADE AWAY FROM PURE JOY." Irene from Tampa

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Old 07-24-2010, 08:14 AM   #7
Sandra in GA
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Re: ALTTO Trial - Herceptin / Tykerb

I was in the trial that preceeded the ALLTO trail. It was the phase II trial to evaluate the tolerability and cardiac safety of adjuntvant trastuzumab and lapatinib at Mayo Clinic in Jacksonville Florida under Dr. Edith Perez. She and a doctor from Denmark are the chairs for the ALLTO trial. I was the last patient to actually finish the phase II trial. I was very lucky because I would not have had a spot if there had not been women who dropped out because of the diarrhea. Rachel, I learned that a low fiber or low residue diet that avoided all dairy products was the answer for me. I have always eaten a high fiber diet, so not having my whole grains and raw veggies and fruits for a year took some getting used to. However, it was well worth the pay off. Good luck to you.

Sandra
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Diagnosed: 7/25/08 ~ age 63, no family history
Surgery: 8/14/08 Bilateral mastectomy; tumor left breast, node dissection; right prophylactic with expanders: 1/12/10 latisimuss dorsi flap on left side: 9/22/10 implants in
Pathology Report: ER/PR-; HER2+ (3+); Grade 3, StageIII; 3cm tumor plus 21/21 lymph nodes positive; 5cm DCIS
Chemo: A/C; Taxol/Herceptin/Tykerb; phase II study at Mayo adding Tykerb for early stage
Radiation: 25 rads
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Old 07-24-2010, 01:09 PM   #8
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Re: ALTTO Trial - Herceptin / Tykerb

Rachel---Almost exactly a year before you will start this trial I declined it. I had almost the exact same tumor type, stage and aggressiveness as you report. My reason for declining it then was the higher cardiac toxicity risk I would get by receiving Adriamycin as part of the chemo that was beginning required at the time . (I understand that the safer TC chemo regimen is now being accepted by the trial.)

But if I knew then as much as I do now about how the Her2 receptor can transmit its growth signals to the cancer cell's nucleus, I would have been jumping for the chance to receive Tykerb. I believe you could come to that same conclusion as you learn more about Her2 and the tyrosine kinase inhibitors, Tykerb and Neratinib. Read as much as you can on this and I believe you will feel more comfortable with your decision. Also, keep in mind that Herceptin would likely never be denied you in the future should the disease progress--but it shouldn't. We may all find one of these days that Tykerb becomes the first-line therapy for early-stage Her2+ breast cancer, equal to or surpassing Herceptin.

Now the side effects profile for Tykerb could be more severe for you than Herceptin would be, but you will be getting a very powerful Her2 blockade as a trade off, as well as be getting a drug that passes through the blood brain barrier. That is very important.

Good luck to you and thank you for being in this trial.
bird
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Male Breast Cancer, DX 5/15/09, IDC, STAGE 1, 1.7 cm, HER2+++, ER+(95%)/PR+(75%), Ki67 40%, grade 3, 0/5 nodes, TX: mastectomy, TCH finished 7/19/10, radiation 6 wks., Tamoxifen on going, bisphosphonate 24 mos.
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Old 07-30-2010, 09:37 AM   #9
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Re: ALTTO Trial - Herceptin / Tykerb

I have volunteered for the ALTTO trial. I will complete all of the consent forms today. My chemo meds will be 6 doses of TCH which should begin in the next week or two. I'm hoping that I get the Tykerb pill. I will let you know what "arm" I'm placed in as soon as it is decisioned.
__________________
6/14/2010 - Self discovered Lump; Age 39
6/24/2010 - Biopsy results confirm breast cancer
Right breast, invasive ductal adenocarcinoma
HER2neu positive, BRAC I & II negative
7/8/2010 - Lumpectomy right breast, sentinel lymph node biopsy, & port-a-cath installed on left
Stage II, Size 3.2cm, Clear Nodes, Clear Margins
8/19/2010 - Chemo begins - Taxotere, Carboplatin, Herceptin & Tykerb all simulanteously; ALTTO trial arm 4
9/9/2010 - Chemo dose #2
9/30/2010 - Chemo dose#3
10/21/2010 - Chemo dose#4
11/11/2010 - Chemo dose#5
12/02/1010 - Chemo dose #6 - WooHoo, it is complete!
12/14/2010 - Simulation & Planning session for radiation
02/18/2011 - Completed radiation treatment (33 rounds)
08/04/2011 - Completed Herceptin & Tykerb
09/30/2013 - ultrasound guided biopsy (following annual MRI)
10/1/2013 - new cancer in left breast. 6mm discovered via MRI
10/28/2013 - bilateral mastectomy - no reconstruction
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Old 07-30-2010, 06:39 PM   #10
1rarebird
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Re: ALTTO Trial - Herceptin / Tykerb

Leslie--Thank you for volunteering for this trial. It will shed extremely important information for one of these days. And that will occur sooner than otherwise because of brave souls like you. Even if you don't get the Tykerb that you want, the Herceptin should work wonders for you too. And you have the port---so you are ready to go either way.
Hoping for the best for you---

bird
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Old 08-07-2010, 11:08 PM   #11
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Re: ALTTO Trial - Herceptin / Tykerb

Best of luck to all on this trial. As you can see from my signature, I was on the Herceptin/Tykerb trial and it was a huge success for me. Wishing you all the very best and hoping for continued success "down the road".

I forget which phase I was on but it was not random. Herrceptin/Tykerb for 3 months.
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Age 47, TN, Diagnosed 05/09
Her2+, ER/PR-, Stage III, 2 tumors = 1 8cm tumor
Grade 3
Sentinel Node Biopsy-speck present in 1 node
Completed 3 month clinical trial of weekly Herceptin and 1000mg Tykerb daily
Tumor no longer present
Right mastectomy and lymph node removal 09/25/09
No cancer present at time of surgery, none in lymph nodes
Start TCH 10/15, every 3 weeks for 4 months followed by radiation
Finished chemo 01/28/10-YEAH!
Herceptin every 3 wks until end of June
Radiation begins 03/01, 6 1/2 weeks
Radiation complete--Yeah!!
Developed lymphedema after radiation
In hospital for 4 days with pneumonia:(
Herceptin done! 06/24/10
Port Removed 07/08/10
Still in PT for lymphedema and mobility issues
DIEP Reconstruction 05/11
I can be changed by what happens to me, but I refuse to be reduced by it~~Maya Angelou
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Old 08-16-2010, 04:27 PM   #12
msleslie
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Re: ALTTO Trial - Herceptin / Tykerb

I just received a call from the Research Nurse. I will be in arm 4 of the ALTTO trial which means I will take taxotere, carboplatin as chemo meds along with tykerb for 12 months. Also I will begin herceptin at the same time as my chemo on 8/19 rather than waiting for chemo to end. I'm excited about this treatment option although somewhat concerned about the amount of meds I will be introducing into my system at one time.
__________________
6/14/2010 - Self discovered Lump; Age 39
6/24/2010 - Biopsy results confirm breast cancer
Right breast, invasive ductal adenocarcinoma
HER2neu positive, BRAC I & II negative
7/8/2010 - Lumpectomy right breast, sentinel lymph node biopsy, & port-a-cath installed on left
Stage II, Size 3.2cm, Clear Nodes, Clear Margins
8/19/2010 - Chemo begins - Taxotere, Carboplatin, Herceptin & Tykerb all simulanteously; ALTTO trial arm 4
9/9/2010 - Chemo dose #2
9/30/2010 - Chemo dose#3
10/21/2010 - Chemo dose#4
11/11/2010 - Chemo dose#5
12/02/1010 - Chemo dose #6 - WooHoo, it is complete!
12/14/2010 - Simulation & Planning session for radiation
02/18/2011 - Completed radiation treatment (33 rounds)
08/04/2011 - Completed Herceptin & Tykerb
09/30/2013 - ultrasound guided biopsy (following annual MRI)
10/1/2013 - new cancer in left breast. 6mm discovered via MRI
10/28/2013 - bilateral mastectomy - no reconstruction
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Old 08-16-2010, 05:01 PM   #13
Sandra in GA
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Re: ALTTO Trial - Herceptin / Tykerb

The great thing is that you will get both Herceptin AND Tykerb. Here's wishing you all the best.
Sandra
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Diagnosed: 7/25/08 ~ age 63, no family history
Surgery: 8/14/08 Bilateral mastectomy; tumor left breast, node dissection; right prophylactic with expanders: 1/12/10 latisimuss dorsi flap on left side: 9/22/10 implants in
Pathology Report: ER/PR-; HER2+ (3+); Grade 3, StageIII; 3cm tumor plus 21/21 lymph nodes positive; 5cm DCIS
Chemo: A/C; Taxol/Herceptin/Tykerb; phase II study at Mayo adding Tykerb for early stage
Radiation: 25 rads
Vaccine: Walter Reed GP2/AE37 vaccine study ~ last booster 9/17/2012
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Old 08-16-2010, 06:20 PM   #14
msleslie
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Re: ALTTO Trial - Herceptin / Tykerb

@Sandra in GA - Thanks! I agree that this appears to be the best thing going right now. I'm also delighted that I don't have to wait until chemo is over before I begin. I'm ready to get this chapter behind me so I can continue with planning my big 40th bday party in March.
__________________
6/14/2010 - Self discovered Lump; Age 39
6/24/2010 - Biopsy results confirm breast cancer
Right breast, invasive ductal adenocarcinoma
HER2neu positive, BRAC I & II negative
7/8/2010 - Lumpectomy right breast, sentinel lymph node biopsy, & port-a-cath installed on left
Stage II, Size 3.2cm, Clear Nodes, Clear Margins
8/19/2010 - Chemo begins - Taxotere, Carboplatin, Herceptin & Tykerb all simulanteously; ALTTO trial arm 4
9/9/2010 - Chemo dose #2
9/30/2010 - Chemo dose#3
10/21/2010 - Chemo dose#4
11/11/2010 - Chemo dose#5
12/02/1010 - Chemo dose #6 - WooHoo, it is complete!
12/14/2010 - Simulation & Planning session for radiation
02/18/2011 - Completed radiation treatment (33 rounds)
08/04/2011 - Completed Herceptin & Tykerb
09/30/2013 - ultrasound guided biopsy (following annual MRI)
10/1/2013 - new cancer in left breast. 6mm discovered via MRI
10/28/2013 - bilateral mastectomy - no reconstruction
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Old 08-16-2010, 09:07 PM   #15
vlcarr
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Re: ALTTO Trial - Herceptin / Tykerb

I think you will definitely kick some cancer butt with Herceptin & Tykerb! As my friend's father told me, throw everything at it you can, and that is exactly what you will be doing.
__________________
Vicky
Age 47, TN, Diagnosed 05/09
Her2+, ER/PR-, Stage III, 2 tumors = 1 8cm tumor
Grade 3
Sentinel Node Biopsy-speck present in 1 node
Completed 3 month clinical trial of weekly Herceptin and 1000mg Tykerb daily
Tumor no longer present
Right mastectomy and lymph node removal 09/25/09
No cancer present at time of surgery, none in lymph nodes
Start TCH 10/15, every 3 weeks for 4 months followed by radiation
Finished chemo 01/28/10-YEAH!
Herceptin every 3 wks until end of June
Radiation begins 03/01, 6 1/2 weeks
Radiation complete--Yeah!!
Developed lymphedema after radiation
In hospital for 4 days with pneumonia:(
Herceptin done! 06/24/10
Port Removed 07/08/10
Still in PT for lymphedema and mobility issues
DIEP Reconstruction 05/11
I can be changed by what happens to me, but I refuse to be reduced by it~~Maya Angelou
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Old 08-17-2010, 07:29 AM   #16
ksrachel
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Re: ALTTO Trial - Herceptin / Tykerb

msleslie: Congratulations on getting arm 4. I have read some preliminary research that the combination Herceptin/Tykerb has the best odds. With my getting arm 2 of ALTTO, I only get Tykerb. I am a little concerned about not getting Herceptin, but so goes the random selection. I decided that once I agreed to participate in the trial, I would no drop out if I did not like the arm I was placed in. Besides, my only option if I dropped out would be to get just Herceptin and no Tykerb. Rachel
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Old 08-23-2010, 10:06 AM   #17
Jackie07
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Re: ALTTO Trial - Herceptin / Tykerb

Rachel,

Don't worry about only getting Tykerb in the trial. Usually the best medicine will be available for all when there's enough evidence showing its superior effect. The molecule of Tykerb is much smaller than Herceptin. As long as there's no progression and your liver reacts well, I think you can feel safe continuing the trial.

Tykerb is usually given along with xeloda. Are you getting xeloda as well?
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Old 09-03-2010, 02:02 PM   #18
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Re: ALTTO Trial - Herceptin / Tykerb

Side Effect: My tongue has dark spots on it similar to what happens when you take pepto bismol for a stomach ache. I did show my chemo nurse when I went for treatment this week. I'm not sure which drug is causing this Taxotere, ,Carboplatin, Hercecptin or Tykerb. Anyone else having this side effect?
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