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Topic: Immunotherapy drugs for breast cancer

Forum: Immunotherapy - Before, During, and After —

Discuss your experiences with the benefits, risks, and side effects of immunotherapy treatment for breast cancer.

Posted on: Mar 18, 2015 03:13PM - edited Jan 2, 2017 10:50PM by JohnSmith

JohnSmith wrote:

Immuno-Oncology (IO) and Immunotherapy drugs are humanity's best shot at beating cancer.

During the last few years, IO has revealed impressive, durable responses in a variety of tumor types for which conventional therapies historically have had limited success (melanoma, leukemia, lymphoma, lung, liver, bladder, etc).
The power of this approach is highlighted in countless articles (like here and here) as well as a variety of TV broadcasts, including:
1. HBO's Vice TV special: "Killing Cancer", explored a subset of IO called "Virotherapy" and how the following three common viruses are genetically modified to find and kill cancer:
- A re-engineered Measles virus was used to treat patients with Multiple Myeloma.
- A re-engineered Adenovirus (like the common cold) to treat patients with Glioblastoma (GBM) brain tumors.
- A re-engineered HIV virus to treat patients with the blood cancer Leukemia.
2. 60 Minutes TV special: "Killing Cancer" focused on curing GBM by using a re-engineered Polio virus.
3. PBS TV special: "Cancer: The Emperor of All Maladies" tells the complete story of cancer, from its history to current breakthroughs. It's six hours long, broken into three videos, with the last part covering IO.

We've reached an inflection point to change the trajectory of breast cancer treatment.
In late 2015, an unprecedented coalition was formed to accelerate progress in IO.
Called the "Cancer Moon Shot 2020" (#CancerMoonShot), this endeavor will bring patients closer to Immunotherapies and precision medicine, by not only exploiting genetics (DNA), but also epigenetics (gene expression), proteomics (protein expression), metabolomics (cancer metabolism). Here's a couple video's discussing the effort:
4. Cancer MoonShot 2020, explained in very simple terms, here.
5. Cancer MoonShot 2020 Press Conference (Jan 2016), here. Listen to the experts.

If you're smart, you asked the question: how can immunotherapy be harnessed in Breast Cancer?

To answer this, I researched the usual resources and was surprised at the paucity of info.
Breastcancer.org's page, Using the Immune Response to Treat BC is outdated and extremely incomplete.
It only discusses these Monoclonal Antibodies (mAbs) used for HER2+ patients:
Herceptin (trastuzumab), Tykerb (lapatinib), Perjeta (pertuzumab), Kadcyla (Trastuzumab or T-DM1).

The Cancer Research Institute's webpage, "Immunotherapy for Breast Cancer", is the most comprehensive resource for US based research, although it was last updated Sept 2014. [Dr. Leisha Emens of John Hopkins reviewed and updated the webpage in March 2016].
It's written that "breast cancer has historically been considered immunologically silent". This statement may contribute to why breast cancer lags behind when compared to other cancers. This notion that breast cancer, in particular ER+ disease, is "not very immunogenic" is an antiquated view that needs to end.
I understand it's "early days", but the breast cancer industry needs a serious paradigm shift.
Listen to this comment at the 2016 CancerMoonShot press conference here). Priorities should be realigned towards the basic science of IO and then translated into cures that exceed the ~7% that standard therapies offer metastatic patients over 10 years (Source: Weissman, June 2015, ~10:00 minute mark).
As patients / caretakers, we should be discussing Immunotherapies with our doctors, encouraging breast cancer researchers to explore this approach and supporting funding efforts aimed at moving the field forward.

So, in a effort to advocate for this community, I wanted to start this topic and get others to ask these questions:

- What progress is being made in Breast Cancer Immunotherapy?
- Who are the thought leaders and researchers in Breast Cancer Immunotherapy?
- Most importantly, where are the Breast Cancer Immunotherapy clinical trials?

Who else shares this sense of urgency?

Wife was Age 45 at Dx 4/2014. BMX Surgery 6/2014 revealed: ILC, Stage 2 (Multifocal ILC, largest lesion 2.2 cm), Grade 2, ER+/PR+ (95%), HER2-, Ki-67 5-10%, Oncotype 11; Variant in the ATM gene Dx 4/8/2014, ILC, Left, 2cm, Stage IIA, Grade 2, 0/3 nodes, ER+/PR+, HER2- (IHC) Surgery 6/26/2014 Mastectomy; Reconstruction (left); Reconstruction (right)
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Mar 19, 2015 08:43AM wallycat wrote:

I'm no expert.

I found this and maybe it will be of some help.

https://www.breastcancertrials.org/bct_nation/brow...


Dx 4/07 1 month before turning 50; ILC 1.8cm, ER+/PR+, HER2 neg., Stage 1, Grade 2, 0/5 nodes. Onco score 20, Bilateral Mast., tamoxifen 3-1/2 years, arimidex-completed 4/20/2012
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Mar 19, 2015 09:02AM - edited Mar 19, 2015 09:03AM by SpecialK

The Her2+ recurrence prevention trial I did was for encouragement of the patient's immune system to fight recurrence through vaccines.

http://www.cancer.gov/clinicaltrials/search/view?c...


BMX w/ TE 11/1/10, ALND 12/6/10. 15 additional surgeries. TCHx6 2/17-6/2/11. Herceptin until 1/19/12. Femara 8/1/11, Arimidex 6/20/12, back to Femara 6/18/13-present. Dx 9/27/2010, IDC, Right, 2cm, Stage IIB, Grade 3, 2/14 nodes, ER+/PR+, HER2+ (IHC) Dx 9/27/2010, DCIS, Stage 0, Grade 3
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Apr 4, 2015 09:21AM chrissie29 wrote:


SpecialK what immune drug was part of your trial?

Dx 7/24/2014, IDC, Left, 6cm+, Grade 1, ER+/PR+, HER2+ (IHC) Dx 7/24/2014, DCIS, Grade 2, ER+/PR+, HER2+ Targeted Therapy 8/7/2014 Herceptin (trastuzumab) Targeted Therapy 8/7/2014 Perjeta (pertuzumab) Chemotherapy 8/7/2014 Taxotere (docetaxel) Chemotherapy 8/30/2014 Carboplatin (Paraplatin) Surgery 12/16/2014 Lymph node removal: Left, Right; Mastectomy: Left; Prophylactic mastectomy: Right; Reconstruction (left): Tissue expander placement; Reconstruction (right): Tissue expander placement Dx 12/17/2014, IDC: Mucinous, Left, 6cm+, Stage IIB, Grade 1, 0/5 nodes, ER+/PR+, HER2+ Radiation Therapy 2/1/2015 Breast, Lymph nodes Hormonal Therapy 3/12/2015 Arimidex (anastrozole), Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Apr 4, 2015 09:29AM SpecialK wrote:

chrissie - it was the GP2 peptide vaccine given with GM-CSF.  This was a two armed trial, and half were given GP2 and half AE37, and some placebo with no vaccine.  The placebo was the GM-CSF, so everybody got something, the GM-CSF is similar to Neulasta/Neupogen so it was potentially immune boosting by itself.  We were sorted into the arms by histological tissue type like for organ transplant compatability, which was independent of any cancer info.

BMX w/ TE 11/1/10, ALND 12/6/10. 15 additional surgeries. TCHx6 2/17-6/2/11. Herceptin until 1/19/12. Femara 8/1/11, Arimidex 6/20/12, back to Femara 6/18/13-present. Dx 9/27/2010, IDC, Right, 2cm, Stage IIB, Grade 3, 2/14 nodes, ER+/PR+, HER2+ (IHC) Dx 9/27/2010, DCIS, Stage 0, Grade 3
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Apr 4, 2015 02:07PM chrissie29 wrote:

SpecialK-are there results from your study yet?  What phase was it?

 

Dx 7/24/2014, IDC, Left, 6cm+, Grade 1, ER+/PR+, HER2+ (IHC) Dx 7/24/2014, DCIS, Grade 2, ER+/PR+, HER2+ Targeted Therapy 8/7/2014 Herceptin (trastuzumab) Targeted Therapy 8/7/2014 Perjeta (pertuzumab) Chemotherapy 8/7/2014 Taxotere (docetaxel) Chemotherapy 8/30/2014 Carboplatin (Paraplatin) Surgery 12/16/2014 Lymph node removal: Left, Right; Mastectomy: Left; Prophylactic mastectomy: Right; Reconstruction (left): Tissue expander placement; Reconstruction (right): Tissue expander placement Dx 12/17/2014, IDC: Mucinous, Left, 6cm+, Stage IIB, Grade 1, 0/5 nodes, ER+/PR+, HER2+ Radiation Therapy 2/1/2015 Breast, Lymph nodes Hormonal Therapy 3/12/2015 Arimidex (anastrozole), Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Apr 4, 2015 02:20PM SpecialK wrote:

I did phase II, which is now closed to enrollment. There is no word yet regarding the start of phase III. Here is the preliminary info:

http://www.mdanderson.org/newsroom/news-releases/2...


BMX w/ TE 11/1/10, ALND 12/6/10. 15 additional surgeries. TCHx6 2/17-6/2/11. Herceptin until 1/19/12. Femara 8/1/11, Arimidex 6/20/12, back to Femara 6/18/13-present. Dx 9/27/2010, IDC, Right, 2cm, Stage IIB, Grade 3, 2/14 nodes, ER+/PR+, HER2+ (IHC) Dx 9/27/2010, DCIS, Stage 0, Grade 3
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Apr 4, 2015 04:43PM chrissie29 wrote:


Thanks for the info.  There is a Phase 2 trial on Neuvax but I might be too late in inquiring because the treatment is supposed to start after the 3rd adjuvant Herceptin.

Dx 7/24/2014, IDC, Left, 6cm+, Grade 1, ER+/PR+, HER2+ (IHC) Dx 7/24/2014, DCIS, Grade 2, ER+/PR+, HER2+ Targeted Therapy 8/7/2014 Herceptin (trastuzumab) Targeted Therapy 8/7/2014 Perjeta (pertuzumab) Chemotherapy 8/7/2014 Taxotere (docetaxel) Chemotherapy 8/30/2014 Carboplatin (Paraplatin) Surgery 12/16/2014 Lymph node removal: Left, Right; Mastectomy: Left; Prophylactic mastectomy: Right; Reconstruction (left): Tissue expander placement; Reconstruction (right): Tissue expander placement Dx 12/17/2014, IDC: Mucinous, Left, 6cm+, Stage IIB, Grade 1, 0/5 nodes, ER+/PR+, HER2+ Radiation Therapy 2/1/2015 Breast, Lymph nodes Hormonal Therapy 3/12/2015 Arimidex (anastrozole), Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Apr 4, 2015 05:20PM SpecialK wrote:

Which trial are you looking at? I had thought that neuvax was for low Her2 expressors.

BMX w/ TE 11/1/10, ALND 12/6/10. 15 additional surgeries. TCHx6 2/17-6/2/11. Herceptin until 1/19/12. Femara 8/1/11, Arimidex 6/20/12, back to Femara 6/18/13-present. Dx 9/27/2010, IDC, Right, 2cm, Stage IIB, Grade 3, 2/14 nodes, ER+/PR+, HER2+ (IHC) Dx 9/27/2010, DCIS, Stage 0, Grade 3
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Apr 4, 2015 09:11PM chrissie29 wrote:


I saw that one but I also saw this one- Phase II Trial of
Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast
Cancer Patients.

Dx 7/24/2014, IDC, Left, 6cm+, Grade 1, ER+/PR+, HER2+ (IHC) Dx 7/24/2014, DCIS, Grade 2, ER+/PR+, HER2+ Targeted Therapy 8/7/2014 Herceptin (trastuzumab) Targeted Therapy 8/7/2014 Perjeta (pertuzumab) Chemotherapy 8/7/2014 Taxotere (docetaxel) Chemotherapy 8/30/2014 Carboplatin (Paraplatin) Surgery 12/16/2014 Lymph node removal: Left, Right; Mastectomy: Left; Prophylactic mastectomy: Right; Reconstruction (left): Tissue expander placement; Reconstruction (right): Tissue expander placement Dx 12/17/2014, IDC: Mucinous, Left, 6cm+, Stage IIB, Grade 1, 0/5 nodes, ER+/PR+, HER2+ Radiation Therapy 2/1/2015 Breast, Lymph nodes Hormonal Therapy 3/12/2015 Arimidex (anastrozole), Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Apr 4, 2015 09:12PM chrissie29 wrote:


SpecialK - maybe I am reading it wrong but I thought is was an active study.

Dx 7/24/2014, IDC, Left, 6cm+, Grade 1, ER+/PR+, HER2+ (IHC) Dx 7/24/2014, DCIS, Grade 2, ER+/PR+, HER2+ Targeted Therapy 8/7/2014 Herceptin (trastuzumab) Targeted Therapy 8/7/2014 Perjeta (pertuzumab) Chemotherapy 8/7/2014 Taxotere (docetaxel) Chemotherapy 8/30/2014 Carboplatin (Paraplatin) Surgery 12/16/2014 Lymph node removal: Left, Right; Mastectomy: Left; Prophylactic mastectomy: Right; Reconstruction (left): Tissue expander placement; Reconstruction (right): Tissue expander placement Dx 12/17/2014, IDC: Mucinous, Left, 6cm+, Stage IIB, Grade 1, 0/5 nodes, ER+/PR+, HER2+ Radiation Therapy 2/1/2015 Breast, Lymph nodes Hormonal Therapy 3/12/2015 Arimidex (anastrozole), Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Oct 15, 2015 05:57PM - edited Aug 6, 2016 11:38PM by JohnSmith

The following link appears to be the most up to date summary of Immunotherapy for breast cancer.
It's mostly a lot of big words that probably won't make much sense unless you're doing daily research.
Someday, I'll edit this post and attempt to match these therapies to the appropriate clinical trials.

"Will immunotherapy help us cure breast cancer?"

1. Monoclonal antibodies (mAbs) currently being researched in breast cancer clinical trials include:
- Avastin (bevacizumab), which targets the tumor growth factor VEGF-A
- Cyramza (ramucirumab), which targets the tumor growth factor VEGFR-2
- MGAH22 (margetuximab), which blocks the action of HER2 on tumor growth
- OMP-18R5 (vantictumab), which targets a tumor growth pathway known as the Wnt beta-catenin signaling pathway
- LJM716, which blocks a protein called HER3 that enables tumors to become resistant to treatment
- LY2875358, an anti-MET antibody
- CDX-011 (glembatumumab vedotin) and IMMU-132, which target cellular proteins that enable tumors to metastasize

2. Therapeutic cancer vaccines currently being researched in breast cancer clinical trials include:
- A HER2 peptide vaccine called NeuVax (nelipepimut-S) UPDATE - JUNE 2016: The NeuVax Phase 3 clinical trial (PRESENT) has been stopped (cancelled), due to futility. NeuVax was unable to prevent recurrence in this trial; a HER2-pulsed dendritic cell vaccine; and the peptide vaccines E39 and J65, which are being tested to prevent breast cancer recurrence
- AVX901, which helps the immune system destroy tumor cells that express HER2
- INO-1400 (by Inovio Pharmaceuticals), a synthetic DNA vaccine targeting the hTERT antigen.
hTERT = human telomerase reverse transcriptase [This is being explored for Triple Negative BC]

3. Checkpoint inhibitors/immune modulators currently being researched in breast cancer clinical trials include:
- The anti-CTLA-4 antibody Yervoy (ipilimumab)
- The anti-PD-1 antibodies Keytruda (pembrolizumab, MK-3475) and Opdivo® (nivolumab)
- The anti-PD-L1 antibodies MPDL3280A and MEDI4736
- The anti-OX40 antibodies MEDI6469 and MEDI6383

4. The following types of adoptive T cell transfer are being researched for patients with breast cancer:
- Tumor infiltrating lymphocytes (TILs) that are removed from a patient's tumor, boosted in the lab, then given back to the patient. This is essentially CAR-T Immunotherapy, which has cured a number of people with hematological malignancies like Leukemia & Lymphoma.
- T cells genetically engineered to target several cancer-associated antigens, including:
* HER2
* cMet protein
* CEA
* VEGFR-2
* MAGE-A3

5. Cytokines currently being researched in clinical trials of breast cancer include the following interleukins:
- Interleukin-2, an important growth factor for white blood cells
- Interleukin-7, an important growth factor for T cells and B cells

6. Adjuvant immunotherapies currently being researched in breast cancer clinical trials include:
- Indoximod, an IDO inhibitor, which blocks an immunosuppressive molecule produced by tumor cells
- Poly-ICLC, a Toll-like receptor (TLR) 3 agonist

Wife was Age 45 at Dx 4/2014. BMX Surgery 6/2014 revealed: ILC, Stage 2 (Multifocal ILC, largest lesion 2.2 cm), Grade 2, ER+/PR+ (95%), HER2-, Ki-67 5-10%, Oncotype 11; Variant in the ATM gene Dx 4/8/2014, ILC, Left, 2cm, Stage IIA, Grade 2, 0/3 nodes, ER+/PR+, HER2- (IHC) Surgery 6/26/2014 Mastectomy; Reconstruction (left); Reconstruction (right)
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Jan 17, 2016 01:15PM - edited Feb 6, 2016 01:15PM by JohnSmith

This is an update on the Immunotherpy drug "Keytruda" (AKA: Pembrolizumab, MK-3475).
Keytruda is a Monoclonal antibody and acts as a checkpoint inhibitor, specifically a PD1 inhibitor. It targets the PD-1 protein on T cells (a kind of immune cell). The drug removes the "brakes" (biological blockades) that keep T cells (also called T lymphocytes) from attacking cancer.
It's FDA approved for Lung cancer and Melanoma (think former President Jimmy Carter). As a single agent (monotherapy), it's shown to be useful in TNBC trials and has similar potential in ER+ disease, as just reported by Dr. Hope Rugo of UCSF, here, "Pembrolizumab's Potential in ER+ / HER2- patients".

As of Feb 2016, Keytruda is in at least 20 different clinical trials for breast cancer, listed below (This may not be a complete list and serves as a springboard to get you started. Please do your own due diligence)

01. metastatic ER+ [NCT02395627] This one deals with Epigenetics, and includes a HDAC inhibitor too!
02. metastatic ER+, HER2- [NCT02054806] KEYNOTE-28 trial. A basket trial evaluating 20 different types of cancer with PD-L1 expression. Results of the ER+, HER2- are here.
03. metastatic IBC [NCT02411656]
04. metastatic TNBC or metastatic ER+, HER2- [NCT02648477]
05. metastatic TNBC [NCT02513472] KEYNOTE-150 trial
06. metastatic TNBC [NCT02447003] KEYNOTE-086 trial
07. metastatic TNBC [NCT02555657] KEYNOTE-119 trial
08. metastatic HER2+ [NCT02129556] PANACEA trial
09. metastatic HER2+ [NCT02318901] PembroMab trial
10. metastatic TNBC & other solid tumors [NCT02646748] This one deals with the Tumor Microenvironment, and includes a JAK inhibitor, and a PI3K inhibitor.
11. TNBC & other solid tumors [NCT02452424] KEYNOTE-103 trial
12. TNBC & other solid tumors [NCT02644369] INSPIRE trial
13. TNBC & other solid tumors [NCT02432963]
14. TNBC [NCT02622074] KEYNOTE 173 trial
15. TNBC and/or HER2+ [NCT02178722] KEYNOTE-037 trial. This one includes a IDO Inhibitor.
16. ER+ & other solid tumors [NCT02331251] PembroPlus trial
17. oligometastatic breast cancer [NCT02303366] BOSTON II trial
18. Any invasive breast cancer [NCT01042379] I-SPY 2 trial. Evaluating numerous agents among 1,200 patients
19. Unknown types of breast cancer [NCT02009449] This one includes AM0010, a humanized version of the immune protein called interleukin-10 (IL-10) - No longer accepting breast cancer patients.
20. metastatic breast cancer & other solid tumors [NCT01174121] This one involves growing patient-extracted "Tumor Infiltrating Lymphocytes" (TILs).

Wife was Age 45 at Dx 4/2014. BMX Surgery 6/2014 revealed: ILC, Stage 2 (Multifocal ILC, largest lesion 2.2 cm), Grade 2, ER+/PR+ (95%), HER2-, Ki-67 5-10%, Oncotype 11; Variant in the ATM gene Dx 4/8/2014, ILC, Left, 2cm, Stage IIA, Grade 2, 0/3 nodes, ER+/PR+, HER2- (IHC) Surgery 6/26/2014 Mastectomy; Reconstruction (left); Reconstruction (right)
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Jan 18, 2016 02:54PM peacestrength wrote:

Thanks, JohnSmith

2013, IDC Stage 3a
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Jan 19, 2016 04:56AM cp418 wrote:

http://www.sciencedaily.com/releases/2016/01/16011...

The largest analysis of breast cancer cell function to date suggests dozens of new uses for existing drugs, new targets for drug discovery, and new drug combinations.

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Jan 28, 2016 02:55PM - edited Nov 30, 2016 10:32PM by JohnSmith

This is an update on the Immunotherapy drug "Opdivo" (AKA: Nivolumab, BMS-936558, MDX-1106)
Like Keytruda (see post above), Opdivo is a Monoclonal antibody and acts as a checkpoint inhibitor, specifically a PD1 inhibitor. It targets the PD-1 protein on T cells (a kind of immune cell). The drug removes the "brakes" (biological blockades) that keep T cells (also called T lymphocytes) from attacking cancer.

As of Nov 2016, Opdivo is approved by the FDA for 5 different cancers:
1. Melanoma.
2. Squamous non-small cell Lung cancer (NCSLC).
3. Kidney cancer (renal cell Kidney cancer - renal cell carcinoma or RCC).
4. Hodgkin Lymphoma (for those that relapsed or progressed after autologous hematopoietic stem cell transplantation [HSCT])
5. Head and Neck (SCCHN) (for recurrent or metastatic squamous cell carcinoma) [Head and neck cancer is a group of cancers that includes cancers of the oral cavity, larynx, pharynx, salivary glands, and nose/nasal passages.] This approval was based on the Phase III Head & Neck clinical trial called CheckMate -141, described here.

As of Feb 2016, Opdivo is being used in the following breast cancer clinical trials (This may not be a complete list and serves as a springboard to get you started. Please do your own due diligence)

1. metastatic TNBC [NCT01928394]
A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors
Estimated Enrollment: 1100
Study Start Date: October 2013
Estimated Primary Completion Date: August 2017
More info from Sloan Kettering, here.
Trial locations include: Colorado, Connecticut, Florida, Georgia, Maryland, Massachusetts, New York, North Carolina, Oregon, Tennessee, Texas, Washington; Canada, Denmark, Finland, Germany, Italy, Spain, United Kingdom, maybe more

2. All breast cancer patients, with exception to HER2+ [NCT02309177]
A Phase 1, Open-Label, Multicenter, Safety Study of Nivolumab (BMS-936558) in Combination With Nab-Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, Nab-Paclitaxel / Carboplatin in Stage IIIB/IV Non-Small Cell Lung Cancer or Nab-Paclitaxel in Metastatic Breast Cancer
Estimated Enrollment: 138
Study Start Date: December 2014
Estimated Primary Completion Date: July 2017
Trial locations include: Arizona, California, Connecticut, Florida, Illinois, Massachusetts, New Jersey, North Carolina, Ohio, Pennsylvania, Washington, Wisconsin, maybe more

3. All Stage III & IV breast cancer patients, with exception to HER2+ [NCT02453620]
A Phase 1 Study Evaluating Safety, Tolerability, and Preliminary Antitumor Activity of Entinostat and Nivolumab With or Without Ipilimumab in Advanced Solid Tumors
Estimated Enrollment: 45
Study Start Date: November 2015
Estimated Primary Completion Date: January 2017
Trial locations include: California, Connecticut, Maryland, Pennsylvania, maybe more

4. metastatic TNBC [NCT02499367]
Adaptive Phase II Randomized Non-comparative Trial of Nivolumab After Induction Treatment in Triple-negative Breast Cancer (TNBC) Patients: TONIC-trial
Estimated Enrollment: 84
Study Start Date: August 2015
Estimated Primary Completion Date: August 2019
Trial locations include: Netherlands, maybe more

** The following involve Opdivo with other experimental agents for various solid tumors (in theory, this includes breast cancer, but requires verification from the trial investigators):

5. metastatic breast cancer [NCT02009449]
A Phase 1, Open-Label Dose Escalation First-in-Human Study to Evaluate the Tolerability, Safety, Maximum Tolerated Dose, Preliminary Clinical Activity and Pharmacokinetics of AM0010 in Patients With Advanced Solid Tumors
Estimated Enrollment: 300
Study Start Date: November 2013
Estimated Primary Completion Date: December 2016
Trial locations include: California, Colorado, Florida, Massachusetts, New York, Oklahoma, Tennessee, Texas, maybe more

6. metastatic breast cancer [NCT02467361]
A Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Cancers
Estimated Enrollment: 120
Study Start Date: August 2015
Estimated Primary Completion Date: August 2017
Trial locations include: Georgia, Illinois, Massachusetts, New York, South Carlina, maybe more.

7. metastatic breast cancer [NCT02423954]
Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus) (NivoPlus)
Estimated Enrollment: 49
Study Start Date: April 2015
Estimated Primary Completion Date: April 2017
Trial locations include: Arizona, maybe more

8. metastatic breast cancer [NCT02483247]
A Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer
Estimated Enrollment: 200
Study Start Date: September 2015
Estimated Primary Completion Date: September 2017
Trial locations include: California, Illinois, Indiana, Louisiana, Massachusetts, Ontario Canada, maybe more

9. metastatic breast cancer & Lymphoma [NCT02253992]
Safety and Tolerability of Urelumab Administered in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkins Lymphoma
Estimated Enrollment: 200
Study Start Date: September 2014
Estimated Primary Completion Date: December 2016
Trial locations include: California, Florida, Illinois, Maryland, Massachusetts, New York, Oregon, Pennsylvania, Texas, France, Germany, Spain, maybe more

10. metastatic breast cancer [NCT02598960]
Study of BMS-986156 Given Alone and in Combination With Nivolumab in Subjects With Advanced Solid Tumors
Estimated Enrollment: 260
Study Start Date: October 2015
Estimated Primary Completion Date: May 2018
Trial locations include: Tennessee, Australia, Ontario Canada, maybe more

11. metastatic breast cancer [NCT02423343]
Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, Hepatocellular Carcinoma, or Glioblastoma
Estimated Enrollment: 100
Study Start Date: October 2015
Estimated Primary Completion Date: April 2018
Trial locations include: Alabama, California, Florida, Massachusetts, North Carolina, Texas, Spain, maybe more

12. metastatic breast cancer [NCT02614456]
Combination of Interferon-gamma and Nivolumab for Advanced Solid Tumors
Estimated Enrollment: 15
Study Start Date: December 2015
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Trial locations include: Pennsylvania, maybe more

13. metastatic breast cancer [NCT01714739]
Phase I Study of an Anti-KIR Antibody in Combination With an Anti-PD1 Antibody in Patients With Advanced Solid Tumors
Estimated Enrollment: 162
Study Start Date: October 2012
Estimated Primary Completion Date: September 2017
Trial locations include: Illinois, Maryland, Massachusetts, New York, Oregon, Pennsylvania, maybe more

14. metastatic breast cancer [NCT01968109]
Study of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
Estimated Enrollment: 540
Study Start Date: October 2013
Estimated Primary Completion Date: September 2016
Trial locations include: Illinois, Maryland, Massachusetts, Michigan, New York, Oregon, Pennsylvania, Texas, Washington, Italy, Japan, Spain, maybe more

15. metastatic breast cancer [NCT02518958]
Phase I, Open-Label, Multiple Ascending Dose Study of RRx-001 and Nivolumab (PRIMETIME)
Estimated Enrollment: 45
Study Start Date: July 2015
Estimated Primary Completion Date: July 2017
Trial locations include: Maryland, maybe more

Wife was Age 45 at Dx 4/2014. BMX Surgery 6/2014 revealed: ILC, Stage 2 (Multifocal ILC, largest lesion 2.2 cm), Grade 2, ER+/PR+ (95%), HER2-, Ki-67 5-10%, Oncotype 11; Variant in the ATM gene Dx 4/8/2014, ILC, Left, 2cm, Stage IIA, Grade 2, 0/3 nodes, ER+/PR+, HER2- (IHC) Surgery 6/26/2014 Mastectomy; Reconstruction (left); Reconstruction (right)
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Jan 30, 2016 05:10PM ellamilana wrote:

Thanks John, good information

Ella Dx 3/29/2012, IDC, Left, 2cm, Stage IV, Grade 3, 14/15 nodes, ER-/PR-, HER2- (FISH)
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Feb 20, 2016 03:00PM JohnSmith wrote:

With the media recently highlighting the remarkable Immunotherapy stories (like here, here, here, and here) of cancer patients achieving "No Evidence of Disease" [NED], I thought it would be wise to remind everyone that Immunotherapy breast cancer clinical trials do exist.
I found 241 clinical trials open for breast cancer Immunotherapy.
11 of the 241 are Phase III trials. The rest are Phase I and II trials.

Here's some resources to find those clinical trials:

1. Cancer Research Institute's: Immunotherapy "Clinical Trial Finder"
Call 1-855-216-0127 (toll-free) to reach a Clinical Trial Navigator who will help identify appropriate trials.

2. NIH Clinical Trials: ClinicalTrials.gov
The world's largest clinical trials database

3. Breast Cancer Trials: BreastCancerTrials.org
Focused on breast cancer. It goes beyond Immunotherapy to include conventional therapies.

Wife was Age 45 at Dx 4/2014. BMX Surgery 6/2014 revealed: ILC, Stage 2 (Multifocal ILC, largest lesion 2.2 cm), Grade 2, ER+/PR+ (95%), HER2-, Ki-67 5-10%, Oncotype 11; Variant in the ATM gene Dx 4/8/2014, ILC, Left, 2cm, Stage IIA, Grade 2, 0/3 nodes, ER+/PR+, HER2- (IHC) Surgery 6/26/2014 Mastectomy; Reconstruction (left); Reconstruction (right)
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Feb 20, 2016 03:38PM Meow13 wrote:

Thank you John. Appreciate your research.

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Feb 20, 2016 03:46PM mike3121 wrote:

Wow, Mr Smith, you sure did a through job. Your lists should probably be posted somewhere as a resource or reference. Looks like 2017 is the year for it all to come together.

Mike W.

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Feb 20, 2016 04:18PM TectonicShift wrote:

I agree. Thanks for all your efforts and info, JohnSmith !!

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Feb 20, 2016 04:19PM MusicLover wrote:

Me too. Thank you again and again!

As per PET scan, 3 or 4 nodules in the right breast, 2 of which were actually in the middle of my chest, the other 2 were side by side in the breast. Also DCIS in the left breast. Dx 9/23/2013, IDC, Right, 2cm, Stage IV, Grade 2, 1/0 nodes, mets, ER+/PR+, HER2- Hormonal Therapy 10/9/2013 Femara (letrozole)
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Feb 20, 2016 06:34PM ellamilana wrote:

Thanks John! so much!

Ella Dx 3/29/2012, IDC, Left, 2cm, Stage IV, Grade 3, 14/15 nodes, ER-/PR-, HER2- (FISH)
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Feb 21, 2016 02:17AM Heidihill wrote:

Wow, Layla's story sounds like science fiction! Thanks for the upbeat news!

Dx 8/2007, IDC, Left, 2cm, Stage IV, metastasized to bone, Grade 2, 2/19 nodes, mets, ER+/PR+, HER2- (FISH) Hormonal Therapy 3/24/2015 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Feb 21, 2016 01:04PM bluedog wrote:

Thanks, John. I'm in a Herceptin/NeuVax trial in DC for low and intermediate HER2 expressors. They're still recruiting, but you have to have just finished treatment.
Lisa -- 56 at diagnosis. Getting Herceptin as part of a clinical trial. Dx 3/2015, DCIS/IDC, Right, 2cm, Stage IIA, Grade 3, 0/3 nodes, ER-/PR-, HER2- (FISH) Chemotherapy 4/4/2015 AC + T (Taxol) Surgery 9/16/2015 Lumpectomy: Right; Lymph node removal: Sentinel Radiation Therapy 10/19/2015 Targeted Therapy 1/14/2016 Herceptin (trastuzumab)
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Feb 21, 2016 03:08PM sueinfl wrote:

Thanks again, John. Here is a link to a thread on the Inspire website that was started by a member who is part of a Tumor-Infiltrating Lymphocyte trial that is really exciting.

https://www.inspire.com/groups/advanced-breast-can...

Sue

Dx 9/18/2009 PILC ER/PR+ HER- stage III Lt Br, TAC chemo first,2/4 nodes +, bilat mx w/HIP at NOLA, no rads DX April 2013 Regional recurrence. Surgery, rads followed by letrozole. 2017 Stage IV mets to bones, liver. Surgery 2/24/2014 Lumpectomy: Left Radiation Therapy 4/13/2014 Breast, Lymph nodes Dx 8/19/2017, ILC, Stage IV, metastasized to bone/liver, ER+/PR-, HER2- Radiation Therapy 8/29/2017 External: Bone Targeted Therapy 9/13/2017 Ibrance (palbociclib) Hormonal Therapy 9/13/2017 Faslodex (fulvestrant)
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Feb 26, 2016 09:48PM waterlady wrote:

There is also a trial for Her2+ breast cancers with Pembrolizumab (Keytruda) https://clinicaltrials.gov/ct2/show/NCT02318901?te...

This Is some of the research that has led to this trial - http://m.cancerdiscovery.aacrjournals.org/content/...

So, it looks like they are looking at it for almost all breast cancers now, except maybe for IBC?

Best wishes to all

We must be the change we wish to see in the world. Dx 3/17/2008, IDC, 5cm, Stage IV, Grade 3, 22/28 nodes, mets, ER-/PR-, HER2+ Radiation Therapy Brain
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Mar 1, 2016 05:39PM sqhataol wrote:

Hi, John!

I am hoping to be a part of the KEYNOTE-086 trial for TNBC at Emory. Thank you for posting this info. I have been trying to find out more, but have not had much luck. I am going for scans, labs, etc next week, and if all goes well will start treatment the next week. My family and I are very encouraged by what we have been told. Please keep posting any info you may find.I would love to hear from anyone who is in the study.

Take care--

Susie

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Mar 6, 2016 07:40PM letmywifelive wrote:

Hi All,

Have you heard about this particular trial and know how it is going ?

https://clinicaltrials.gov/ct2/show/NCT01174121?te...

Thanks.

Dx 10/2013, ILC/IDC, Left, Stage IIB, 2/2 nodes, ER+/PR+, HER2- Dx 2/2016, Stage IV, metastasized to bone, ER+/PR+, HER2- Dx 1/2017, Stage IV, metastasized to liver, ER+/PR-, HER2- Chemotherapy Halaven (eribulin) Chemotherapy AC + T (Taxol) Hormonal Therapy Femara (letrozole) Targeted Therapy Ibrance (palbociclib) Hormonal Therapy Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone) Radiation Therapy Whole-breast: Breast, Lymph nodes Radiation Therapy External: Bone Chemotherapy Xeloda (capecitabine)
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Mar 6, 2016 08:25PM sueinfl wrote:

There is a woman on the Inspire website who has seen a 60% reduction in her tumors since receiving her primed T-cells. You can read about it following this link. https://www.inspire.com/groups/advanced-breast-can...

Sue

Dx 9/18/2009 PILC ER/PR+ HER- stage III Lt Br, TAC chemo first,2/4 nodes +, bilat mx w/HIP at NOLA, no rads DX April 2013 Regional recurrence. Surgery, rads followed by letrozole. 2017 Stage IV mets to bones, liver. Surgery 2/24/2014 Lumpectomy: Left Radiation Therapy 4/13/2014 Breast, Lymph nodes Dx 8/19/2017, ILC, Stage IV, metastasized to bone/liver, ER+/PR-, HER2- Radiation Therapy 8/29/2017 External: Bone Targeted Therapy 9/13/2017 Ibrance (palbociclib) Hormonal Therapy 9/13/2017 Faslodex (fulvestrant)
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Mar 6, 2016 09:17PM JohnSmith wrote:

Thanks Sue. I'll reply to your PM tomorrow.

@letmywifelive
That trial, "Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer" [NCT01174121], is being run by Dr. Steven Rosenberg at the NCI, who is a bit of a Immunotherapy rockstar.

The trouble is that this trial only accepts Stage IV patients that have failed "standard" therapies.
Note the following inclusion criteria:
"All patients must be refractory to approved standard systemic therapy."
Specifically, "Breast and Ovarian cancer patients must be refractory to both 1st line and 2nd line treatments and must have received at least one second line chemotherapy regimen."

I assume your wife wants to avoid chemo. There must be trials that circumvent this requirement. I think it might be a good idea to call the Clinical Trial CRI hotline (855-216-0127) to discover those options.

Wife was Age 45 at Dx 4/2014. BMX Surgery 6/2014 revealed: ILC, Stage 2 (Multifocal ILC, largest lesion 2.2 cm), Grade 2, ER+/PR+ (95%), HER2-, Ki-67 5-10%, Oncotype 11; Variant in the ATM gene Dx 4/8/2014, ILC, Left, 2cm, Stage IIA, Grade 2, 0/3 nodes, ER+/PR+, HER2- (IHC) Surgery 6/26/2014 Mastectomy; Reconstruction (left); Reconstruction (right)

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