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Old 08-22-2013, 05:14 PM   #1
Mtngrl
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Location: Denver, CO
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New Vaccine Trials for Metastatic Breast Cancer

The other day MedPage Today had an article on novel immune therapies for metastatic breast cancer. I was particularly intrigued by the one that is designed for HER-2 cancers (not just in the breast) that involves a custom-made vaccine from the patient's own tissues.

I told my oncologist I'm still interested in doing a vaccine trial, and she replied that the HER-2 study is being done where I get treated. She said they use tumor tissue to generate the vaccine. I have never had surgery, so if she means live tissue from the original tumor, I can do that. She asked me if I wanted to talk to the study folks and I said yes.

Here's how the article describes it:
An NCI-sponsored MBC trial is testing a therapeutic cancer vaccine designed to stimulate the immune system to recognize human epidermal growth factor receptor 2 (HER2).3 The vaccine, called AdHER2/neu dendritic cell vaccine, is custom-made using an individual patient's own immune cells. This 1-year, phase I trial will determine the immunogenicity related to anti-HER2/neu antibody concentrations and the impact of the autologous AdHER2 dendritic cell vaccine on tumor growth and regression rates, disease status, and vaccine-induced antibody profiles. The vaccine is being studied in HER2-positive breast cancer as well as other types of HER2-positive solid tumors.
Here's the link: http://www.medpagetoday.com/resource...&mu_id=5390856

I'll keep you posted.
__________________
Amy
_____________________________
4/19/11 Diagnosed invasive ductal carcinoma in left breast; 2.3 cm tumor, 1 axillary lymph node, weakly ER+, HER2+++
4/29/11 CT scan shows suspicious lesions on liver and lungs
5/17/11 liver biopsy
5/24/11 liver met confirmed--Stage IV at diagnosis
5/27/11 Begin weekly Taxol & Herceptin for 3 months (standard of care at the time of my DX)
7/18/11 Switch to weekly Abraxane & Herceptin due to Taxol allergy
8/29/11 CT scan shows no new lesions & old lesions shrinking
9/27/11 Finish Abraxane. Start Herceptin every 3 weeks. Begin taking Arimidex
10/17/11--Brain MRI--No Brain mets
12/5/11 PET scan--Almost NED
5/15/12 PET scan shows progression-breast/chest/spine (one vertebra)
5/22/12 Stop taking Arimidex; stay on Herceptin
6/11/12 Started Tykerb and Herceptin on clinical trial (w/no chemo)
9/24/12 CT scan--No new mets. Everything stable.
3/11/13 CT Scan--two small new possible mets and odd looking area in left lung getting larger.
4/2/13--Biopsy of suspicious area in lower left lung. Mets to lung confirmed.
4/30/13 Begin Kadcyla/TDM-1
8/16/13 PET scan "mixed," with some areas of increased uptake, but also some definite improvement, so I'll stay on TDM-1/Kadcyla.
11/11/13 Finally get hormone receptor results from lung biopsy of 4/2/13. My cancer is no longer ER positive.
11/13/13 PET scan mixed results again. We're calling it "stable." Problems breathing on exertion.
2/18/14 PET scan shows a new lesion and newly active lymph node in chest, other progression. Bye bye TDM-1.
2/28/14 Begin Herceptin/Perjeta every 3 weeks.
6/8/14 PET "mixed," with no new lesions, and everything but lower lungs improving. My breathing is better.
8/18/14 PET "mixed" again. Upper lungs & one spine met stable, lower lungs less FDG avid, original tumor more avid, one lymph node in mediastinum more avid.
9/1/14 Begin taking Xeloda one week on, one week off. Will also stay on Herceptin and Perjeta every three weeks.
12/11/14 PET Scan--no new lesions, and everything looks better than it did.
3/20/15 PET Scan--no new lesions, but lower lung lesions larger and a bit more avid.
4/13/15 Increasing Xeloda dose to 10 days on, one week off.
7/1/15 Scan "mixed" again, but suggests continuing progression. Stop Xeloda. Substitute Abraxane every 3 weeks starting 7/13.
10/28/15 PET scan shows dramatic improvement everywhere. All lesions except lower lungs have resolved; lower lungs noticeably improved.
12/18/15 Last Abraxane. Continue on Herceptin and Perjeta alone beginning 1/8/16.
1/27/16 PET scan shows cancer is stable.
5/11/16 PET scan shows uptake in some areas that were resolved on the last two scans.
6/3/16 Begin Kadcyla and Tykerb combination
6/5 - 6/23 Horrible diarrhea from K&T together. Got pneumonia.
7/15/16 Begin Kadcyla only every 3 weeks.
9/6/16 Begin radiation therapy on right lung lesion that caused the pneumonia.
10/3/16 Last of 12 radiation treatments to right lung.
11/4/16 Huffing and puffing, low O2, high heart rate, on tiniest bit of exertion. Diagnosed as radiation pneumonitis. Treated with Prednisone.
11/11/16 PET scan shows significant improvement to radiated part of right lung BUT a bunch of new lung lesions, and the bone met is getting worse.
11/22/16 Begin Eribulin and Herceptin. H every 3 weeks. E two weeks on, one week off.
3/6/17 Scan shows progression in lungs. Bone met a little better.
3/23/17 Lung biopsy. Tumor sampled is ER-, PR+ (5%), HER2+++. Getting Herceptin and Perjeta as a maintenance treatment.
5/31/17 Port placement
6/1/17 Start Navelbine & Tykerb
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Old 08-22-2013, 06:15 PM   #2
jacqueline1102
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Posts: 183
Re: New Vaccine Trials for Metastatic Breast Cancer

Thanks so much for this, Amy. Hope you are well. I always enjoy reading your posts.

Take care,

Jackie
__________________
10/11 IBC Stage IV; 1 liver met 4.6 cm.
10/11-2/12 TCH for 6 rounds
3/12 Right MRM
5/12-7/12 33 Radiation treatments
8/1/12 Started Perjeta along with the Herceptin
10/12 Scans said NED for first time
5/15 UWSeattle Vaccine Trial 3 months
12/16 Scans still show NED. Herceptin and Perjeta continue indef.
8/17 Taken off Perjeta;staying on Herceptin. Still NEAD.
3/18 Still NEAD
8/19 Now on Subcutaneous Herceptin
10/21 Remain on Subcutaneous Herceptin (Hylecta)
11/21 CT showed possible lung mets. Was told to wait and see until scan
1/22 CT shows continued growth
03/22 Lung Biopsy said sample was too small but nodules keep growing and IR is convinced that it is indeed cancer
04/22 Oncologist referred for consult for a transbronchial biopsy. This does not sound pleasant
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Old 08-23-2013, 07:51 AM   #3
Rolepaul
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Location: Boulder Colorado as of January 2013
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Re: New Vaccine Trials for Metastatic Breast Cancer

http://regulatoryaffairs.pharmaceuti...-neuvax-220813
Another vaccine that was approved in Europe.
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Old 08-23-2013, 11:17 AM   #4
'lizbeth
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Re: New Vaccine Trials for Metastatic Breast Cancer

Amy,

I am so pleased that you are considering a dendritic vaccine trial. I had the impression that it was created from a blood draw, not the tumor tissue. So am quite curious to learn how the vaccine actually works.

I'm really excited that this is available for stage IV. I hope that you find it is perfect for you, and it takes out those pesky cancer cells cold with minimal side effects.

@RolePaul - I thought the same at first. This is one of the vaccines I follow closely because I know some of the clinical trial doctors and nurse from my own treatments. I see Galena Biopharma received a patent, expanding intellectual property which I believe is different than a drug approval.

Neuvax is in Phase III trials in the US. The PRESENT trial for low and intermediate expressors: Her2 1+ and Her2 2+. It has also entered a Phase IIb trial with Herceptin and Neuvax for the low and intermediate expressors.

Based on a successful Phase 2 trial, which achieved its primary endpoint of disease-free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study. The PRESENT trial is ongoing and additional information on the study can be found at www.neuvax.com. A randomized, multicenter investigator sponsored, 300 patient Phase 2b clinical trial is also enrolling patients to study NeuVax in combination with Herceptin(R) (trastuzumab; Genentech/Roche).

I personally hope that we high expressors will be included in the final drug approval. But I do not see clinical trials for the HER2 3+ with the vaccines I follow. There is some enrollment is specific locations for the Phase IIa AE37 clinical trial, which is a second generation vaccine after Neuvax. But I expect AE37 to switch to the larger market of low and intermediate expressors.

I am not that familiar with the FDA approval process, but am starting to feel that I was lucky enough to receive a vaccine. But will other Her2 3+ survivors miss out because the market is too small?
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