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Topic: ILC Clinical Trials - official thread

Forum: ILC (Invasive Lobular Carcinoma) — Just diagnosed, in treatment, or finished treatment for ILC.

Posted on: Aug 6, 2016 06:13PM - edited Feb 10, 2019 05:57PM by JohnSmith

JohnSmith wrote:

ILC is chronically understudied and poorly understood. For decades the dogma prevailed that ILC was little different than IDC. Treatment protocols for ILC have (and still are) been based on Clinical Trials that are heavily weighted with IDC patients (at best, no more than ~20% of trial participants are ILC). Extrapolating clinically relevant info from this minority representation is a problem and histology (ILC vs. IDC) subtype analysis is rarely done. Now that numerous large research studies have elucidated on histology differences, we are at an apex where science can begin to explore therapies that cater to the unique characteristics that define ILC and generate better patient outcome.

Science advances with clinical trial participation. Knowledge gained through trials leads to better treatment.
In 2015, for the first time in human history, two clinical trials focused on ILC were launched.
A third clinical trial that encourages ILC patient enrollment was announced in May 2016. It's not much, but these three clinical trials are a start.
The purpose of this thread is to encompass all ILC trials. It will be updated as new trials are launched.

1. ILC Biomarker Clinical Trial
"A Trial of Endocrine Response in Women With Invasive Lobular Breast Cancer".
Source: https://clinicaltrials.gov/ct2/show/NCT02206984
Sponsor: University of Pittsburgh - Magee-Womens Hospital of UPMC in Pittsburgh, Pennsylvania, USA.

Estimated Enrollment: 150
Study Start Date: August 2015
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Locations open and recruiting:
USA, Pennsylvania, Pittsburgh - Magee-Womens Hospital of UPMC (Primary site)
USA, Alabama, Birmingham - UAB Comprehensive Cancer Center
USA, California, San Francisco - UCSF
USA, Illinois, Chicago - Univ. of Chicago Medical Center
USA, Minnesota, Rochester - Mayo Clinic
USA, New York, Bronx - Albert Einstein College of Medicine
USA, North Carolina, Chapel Hill - Univ. of North Carolina at Chapel Hill
USA, Texas, Houston - MD Anderson
USA, Texas, Houston - Baylor College of Medicine
USA, Washington, Seattle - SCCA / Fred Hutch

Other proposed locations for Trial participation include:
- University of Alabama in Tuscaloosa, Alabama
- Dana Farber in Boston, Massachusetts
- an institution in Indiana (more details needed).

Additional Notes: This trial is focused on Postmenopausal patients who were "just diagnosed" and have NOT had surgery yet.
This is a pre-surgical "window" Trial to identify Biomarkers of endocrine response in ILC.
They will treat patients during the ~3 week period between initial diagnosis and surgery, using one of three standard endocrine therapies [Tamoxifen or Arimidex or Faslodex], and then compare Biomarkers at pre-therapy (diagnosis) against post-therapy (surgery). The goal is to assess how ILC tumors are responding to the different endocrine therapies.

Press Release: wwww.upmchamot.com/media/NewsReleases/2015/Pages/junkowitz-ilc-trial.aspx

If anyone with ILC expects progress, it's crucial that new ILC patients (who have NOT had surgery yet) enroll in this trial.
Only new patients who are Stage I through Stage III are eligible.
The pace of science is often slow. A common bottleneck that prevents research progress is lack of trial participation. It's important that patients are aware of this trial. It warrants promotion and advertisement. The sooner patients enroll, the sooner the discoveries are made, the sooner new therapies arrive. I cannot emphasize enough the importance of this trial. It would be disappointing if it were cancelled due to lack of participation.

2. PELOPS Clinical Trial [This is the newest trial and announced in May 2016]
Title: "Palbociclib and Endocrine Therapy for Lobular Breast Cancer Preoperative Study"
Source: https://clinicaltrials.gov/ct2/show/NCT02764541
Sponsor: Dana-Farber Cancer Institute in Boston, Massachusetts, USA.

Estimated Enrollment: 180
Study Start Date: May 2016
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)

Locations open and recruiting:
USA, Connecticut, Stamford - Stamford Hospital
USA, Maine, Brewer - Eastern Maine Medical Center
USA, Massachusetts, Boston - Dana-Farber at St. Elizabeth's Medical Center
USA, Massachusetts, Boston - Beth Israel Deaconess Medical Center
USA, Massachusetts, Boston - Dana-Farber Cancer Institute
USA, Massachusetts, Milford - DF/BWCC at Milford Regional Medical Center
USA, Massachusetts, South Weymouth - DF/BWCC in clinical affiliation with South Shore Hospital
USA, Rhode Island, Providence - Lifespan
USA, Tennessee, Nashville - Sarah Cannon Research Institute
USA, Tennessee, Nashville - Vanderbilt University Medical Center

NOTES:
This is a randomized Phase II study of Palbociclib with Femara versus Femara alone.
Palbociclib (AKA: Ibrance), is a CDK4 / CDK6 inhibitor for the treatment of ER+ / HER2- disease.
This is for:
- For early-stage patients (i.e. Stage I to III)
- For Postmenopausal (or Premenopausal who have done Ovarian suppression or had an Oophorectomy) patients.

Interestingly, a very similar trial called PALLAS (see here: https://clinicaltrials.gov/ct2/show/NCT02513394) was launched last year. PALLAS is a large study of ~5000 patients investigating if Ibrance improves outcome. Like the new PELOPS trial, it's also targeting early stage patients.
These trials are being launched due to the success of the PALOMA-1 trial that showed Ibrance extended survival for advanced staged patients, thus leading to FDA approval of the drug in Feb 2015 for metastatic settings.
Here's an 8 minute video with Dr. Erica Mayer of Dana Farber discussing Ibrance and the PALLAS trial.
http://www.slideshare.net/DanaFarber/new-research-in-treating-erpositive-breast-cancer

3. POSEIDON Clinical Trial (organized by the RATHER consortium in Europe - www.ratherproject.com)
Source: https://clinicaltrials.gov/ct2/show/NCT02285179
Title: "Phase I/Prospective Randomized Phase II Trial of the Safety and Efficacy of Tamoxifen in Combination with GDC-0032 compared with Tamoxifen alone."
Sponsor: The Netherlands Cancer Institute

Estimated Enrollment: 32 (for the Phase I portion)
Study Start Date: November 2014
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Locations open and recruiting: Ireland (Dublin), Netherlands (Amsterdam), UK (Cambridge), Spain (Barcelona), France (Paris) and Sweden (Lund).

NOTES:
Phase I is done.
Phase II enrollment is ongoing.
Recent large studies (US-based TCGA and Europe-based RATHER/Jules Bordet) have shown that ~50% of ILC has mutations in at least one of the three key genes of the PI3K pathway (PIK3CA, PTEN, and AKT1). This Trial uses a 2nd generation PI3K inhibitor known as GDC-0032 or Taselisib (developed by Genentech/Roche).
This is for:
- For Metastatic (Stage IV) patients.
- For Postmenopausal or Premenopausal patients.

Interestingly, this second generation PI3K inhibitor (Taselisib) is being used in eight other clinical trials, including the SANDPIPER trial.
SANDPIPER is a Phase III trial enrolling 600 Metastatic Stage IV patients with multiple enrollment locations throughout the USA.

Here's the Sandpiper info:
Source: https://clinicaltrials.gov/ct2/show/study/NCT02340221
Title: "A Study of Taselisib + Fulvestrant versus Placebo + Fulvestrant in patients with Advanced or Metastatic Breast Cancer who have Disease Recurrence or Progression during or after Aromatase Inhibitor therapy"

Estimated Enrollment: 600
Study Start Date: April 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

* Unfortunately, none of these Taselisib trials (or even the POSEIDON trial) mention the word "Lobular" anywhere in the clinicaltrials.gov trial page, which defies all logic.

4. Immunotherapy Clinical Trial - Code named GELATO (or M17GEL).

This is GREAT news and represents the worlds first Lobular clinical trial using Immunotherapy.
The Netherlands Cancer Institute, in conjunction with Roche Genentech, recently announced a Immunotherapy Clinical Trial [NCT03147040] specifically for metastatic ILC. Code named GELATO (or M17GEL), this trial is a needed step in the evolution towards better therapies. As some know, Immunotherapy drugs have been useful in curing *some* metastatic cancer patients (Melanoma, Lung, Bladder, etc). Early results in "general" Immuno-Oncology breast cancer trials have been modest with no more than ~20% of patients achieving durable responses (Triple Negative patients have benefited the most). Science is just scratching the surface of what's possible with Immunotherapy drugs.
The immunotherapy being used is Atezolizumab (Brand name: Tecentriq). It's a Checkpoint Inhibitor targeting a cell surface protein called PD-L1, which is often over-expressed in cancer. The expression of this protein on the cancer cell tells the immune system to back off. The theory is that Atezolizumab may reverse T-cell inactivation and activate the immune system to exert a cytotoxic T-lymphocyte (CTL) response against PD-L1-expressing tumor cells. Basically, it interrupts the communication between the cancer cell and immune cells, thus allowing the T-Cells of our immune system to "wake up" and "recognize" the cancer and attack. Cancer uses many tricks to fool our immune system. In this case, the existence of PD-L1 protein acts as a "Brake" preventing the T-Cells from attacking. Atezolizumab helps release the "brake".

Trial Link: https://clinicaltrials.gov/show/NCT03147040

Estimated Enrollment: 40
Anticipated Study Start Date: July 2017
Estimated Primary Completion Date: July 2019

LOCATIONS (4):
Netherlands
1. Antoni van Leeuwenhoek
Amsterdam, Netherlands
Contact: Marleen Kok, MD +3120512 ext 9111 m.kok@nki.nl
Contact: Ingrid AM Mandjes, MSc +3120512 ext 9111 i.mandjes@nki.nl
Principal Investigator: Marleen Kok, MD

2. UMCG
Groningen, Netherlands
Contact: C Schroder, MD
Principal Investigator: C Schroder, MD

3. Maastricht University Medical Center
Maastricht, Netherlands
Contact: V Tjan-Heijnen, Prof. MD
Principal Investigator: V Tjan-Heijnen, Prof. MD

4. Erasmus Medical Center Cancer Institute
Rotterdam, Netherlands
Contact: A Jager, MD
Principal Investigator: A Jager, MD

5. ROLO CLINICAL TRIAL

As many know, the UK-based ROLO clinical trial for advanced lobular breast cancer was announced in April 2018. It's now on the clinicaltrials.gov website, allowing review of the inclusion/exclusion criteria. This trial exploits the concept of "Synthetic Lethality". In Lobular breast cancer (and HDGC gastric cancer), the CDH1 gene is often mutated causing the loss of the E-Cadherin (E-cad) protein. E-Cad loss might contribute to metastasis. Most cancer therapies work by targeting "over-expression" or "gains" (Herceptin for HER2+ amplification is a good example). However, because E-cad is a tumor suppressor protein and "lost" from the cancer cell, it is not a conventional drug target. The synthetic lethality approach is to target a mutated gene that is over-expressed and interacts with (or relies on) CDH1. If you knock out this other gene associated with CDH1, then you might be able to stop proliferation. In this case, ROS1 is the target. Data suggests that loss of E-cad and ROS1 depend on each other, creating the druggable vulnerability.
For this specific trial, they are combining the ROS1 inhibitor, Crizotinib (Xalkori), with Fulvestrant (Faslodex). It will enroll Pre-menopausal or Post-menopausal women.
Here's the media release from April 2018:
https://breastcancernow.org/breast-cancer-research/our-research-projects/rolo-trial-for-advanced-lobular-breast-cancer
Updates to follow.
Trial Link: https://clinicaltrials.gov/ct2/show/study/NCT03620643

====

More to follow... Please let me know if a Trial needs to be added to this list.

Off topic. For those on Facebook, an ILC group was created last year. Feel free to join: www.facebook.com/groups/Lobular

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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Aug 8, 2016 06:19AM Mixedfeelings wrote:

thank you for all the information you provide.


9/12 diagnosed 5cm lobular, LB, dense tissue, ER+, PR+, HER2 -, Chemotherapy 9/8/2012 AC + T (Taxol) Hormonal Therapy Femara (letrozole) Radiation Therapy Whole-breast: Breast, Lymph nodes, Chest wall
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Nov 18, 2016 03:44PM trinigirl50 wrote:

thank you John. Your research and reports back to the community are invaluable.

trinigirl50 Dx 3/7/2015, ILC, Left, 6cm+, Stage IIIC, Grade 2, 20/24 nodes, ER+/PR-, HER2- Surgery 3/7/2015 Lymph node removal: Underarm/Axillary; Mastectomy: Left; Prophylactic mastectomy: Right Chemotherapy 4/13/2015 AC + T (Taxotere) Hormonal Therapy 9/14/2015 Arimidex (anastrozole), Femara (letrozole) Radiation Therapy 10/1/2015 Whole-breast: Breast, Lymph nodes
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Dec 2, 2016 03:54PM Huffpuff wrote:

What about the Rather Project? www.ratherproject.com

It looks like they could be very helpful to ILC ladies.

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Dec 2, 2016 11:45PM Licata519 wrote:

Very interesting. I'll take it....

Dx 8/26/2016, ILC, Left, 1cm, Stage IIA, Grade 2, 1/2 nodes, ER+/PR+, HER2- Surgery 9/18/2016 Lumpectomy: Left, Right; Lymph node removal: Left, Sentinel Radiation Therapy 11/8/2016 Whole-breast: Breast, Lymph nodes Hormonal Therapy Femara (letrozole)
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Dec 4, 2016 11:49PM - edited Feb 7, 2017 10:12AM by JohnSmith

@HuffPuff. Yes, the 3rd trial (POSEIDON Clinical Trial) is associated with the RATHER project in Europe.

The ILC Biomarker trial in Pittsburgh has expanded enrollment to include 2 additional locations.
Here's all three sites that are enrolling post-menopausal patients who are Stage 1, Stage 2, or Stage 3:
1. UPMC - University of Pittsburgh in Pennsylvania
2. MD Anderson in Houston, Texas
3. Mayo Clinic in Rochester, Minnesota

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 7, 2017 10:14AM JohnSmith wrote:

Another minor news update:
The ILC Biomarker trial in Pittsburgh has expanded enrollment to include 3 additional locations.
Here's all four locations that are enrolling post-menopausal Lobular patients who are Stage 1, Stage 2, or Stage 3:
1. UPMC - University of Pittsburgh in Pennsylvania
2. MD Anderson in Houston, Texas
3. Mayo Clinic in Rochester, Minnesota
4. ** NEW ** Seattle Cancer Care Alliance (SCCA) in Seattle, Washington [Fred Hutch Cancer Research Center]
{Source: https://www.seattlecca.org/clinical-trials/breast-cancer-NCT02206984}

If you are newly diagnosed with Lobular and have NOT had surgery yet, please consider enrolling in this critically important Clinical Trial.

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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Apr 16, 2017 07:52PM jenn70 wrote:

Hi John,

I am newly diagnosed ILC, no surgery yet and going to MD Anderson next week for second opinion. Do you happen to have the link for the clinical trial there?

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Apr 18, 2017 09:05PM JohnSmith wrote:

@jenn70. Sorry for the slow reply. I'm not logging in as much these days. Thank you for expressing interest in the ILC Biomarker trial.

Here's the ILC trial info for MD Anderson (MDA). I don't believe MDA has a dedicated link for the trial. The following info is from the clinicaltrial.gov page, which is found here: https://clinicaltrials.gov/ct2/show/NCT02206984

Mention the "ILC Biomarker" trial to the Oncologist or ask to connect with one of the people below. It may make more sense to reach out to them in advance and let them know you're coming in for a second opinion and interested in learning more about the trial.

Contact:
Alastair Thompson, MD:
713-745-2792
athompson1 AT mdanderson DOT org

Contact:
Jaime Crow, MS
717-792-6443
jrcrow AT mdanderson DOT org

Best of luck!

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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May 8, 2017 02:48PM Moderators wrote:

By the way, in case anyone is interested in participating:

Interview Opportunity: Foundation Medicine, a leader in biomarker testing, is seeking to better understand the patient experience and perceptions of biomarker testing (also referred to as molecular, tumor, or genomic testing). If you have had biomarker (genomic) testing, and live in the USA, they'd welcome the opportunity to speak with you. In appreciation of your time and for sharing your perspectives, they'll provide you with a $50 Amazon gift card. If you fit the criteria, and are interested, please email tamar.sekayan@rx4good.com. They will schedule time for a phone conversation that should last approximately 45 minutes to 1 hour.

To send a Private Message to the Mods: community.breastcancer.org/mem...
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May 15, 2017 10:00AM - edited May 27, 2017 08:10PM by JohnSmith

Do you have Stage 4 ILC and live in the Netherlands? If so, you may want to participate in the worlds first Lobular clinical trial using Immunotherapy.

The Netherlands Cancer Institute, in conjunction with Roche Genentech, recently announced a Immunotherapy Clinical Trial [NCT03147040] specifically for metastatic ILC which will launch in Summer 2017. Code named GELATO (or M17GEL), this trial is a needed step in the evolution towards better therapies. As some know, Immunotherapy drugs have been useful in curing *some* metastatic cancer patients (Melanoma, Lung, Bladder, etc) who failed multiple lines of 'standard of care' therapies. Early results in "general" Immuno-Oncology breast cancer trials have been modest with no more than ~20% of patients achieving durable responses (Triple Negative patients have benefited the most). However, science is just scratching the surface of what's possible with Immunotherapy drugs and those numbers will improve.
The immunotherapy being used is Atezolizumab (Brand name: Tecentriq). It's a Checkpoint Inhibitor targeting a cell surface protein called PD-L1, which is often over-expressed in cancer. The expression of this protein on the cancer cell tells the immune system to back off. The theory is that Atezolizumab may reverse T-cell inactivation and activate the immune system to exert a cytotoxic T-lymphocyte (CTL) response against PD-L1-expressing tumor cells. Basically, it interrupts the communication between the cancer cell and immune cells, thus allowing the T-Cells of our immune system to "wake up" and "recognize" the cancer and attack. Cancer uses many tricks to fool our immune system. In this case, the existence of PD-L1 protein acts as a "Brake" preventing the T-Cells from attacking.

Slightly off topic, new research identified a previously unrecognized role of PD-L1 as a pain inhibitor and a neuromodulator. Cancer cells "jam" this cell receptor to prevent pain signals from reaching your brain. This helps explain why cancer doesn't cause any pain until the disease is advanced. A change in your "pain tolerance" may be one way to determine if Checkpoint Blockade is working. See this article for more info.


Trial Link: https://clinicaltrials.gov/show/NCT03147040

Estimated Enrollment: 40
Anticipated Study Start Date: July 2017
Estimated Primary Completion Date: July 2019

LOCATIONS (4):
Netherlands
1. Antoni van Leeuwenhoek
Amsterdam, Netherlands
Contact: Marleen Kok, MD +3120512 ext 9111 m.kok AT nki DOT nl
Contact: Ingrid AM Mandjes, MSc +3120512 ext 9111 i.mandjes AT nki DOT nl
Principal Investigator: Marleen Kok, MD

2. UMCG
Groningen, Netherlands
Contact: C Schroder, MD
Principal Investigator: C Schroder, MD

3. Maastricht University Medical Center
Maastricht, Netherlands
Contact: V Tjan-Heijnen, Prof. MD
Principal Investigator: V Tjan-Heijnen, Prof. MD

4. Erasmus Medical Center Cancer Institute
Rotterdam, Netherlands
Contact: A Jager, MD
Principal Investigator: A Jager, MD

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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May 26, 2017 03:50AM - edited May 26, 2017 12:18PM by ShetlandPony

JohnSmith, do you know why the researchers decided to do a PD-L1 trial with (metastatic) ILC in particular? Is it more likely to have mismatch repair gene mutationsor micro-satellite unstable genes than IDC? Or some other reason? See JFL's post about the recent FDA approval of such drugs.

https://community.breastcancer.org/forum/8/topics/...



2011 Stage I ILC 1.5cm grade1 ITCs sn Lumpectomy,radiation,tamoxifen. 2014 Stage IV ILC mets breast,liver. TaxolNEAD. Ibrance+letrozole 2yrs. Fas+afinitor nope. XelodaNEAD 2yrs. Eribulin,Doxil nope. SUMMIT FaslodexHerceptinNeratinib for Her2mut NEAD
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Jun 20, 2017 05:06AM - edited Jun 20, 2017 11:01AM by Lab-girl

Dear ShetlandPony, John may have more information but I have been studying this connection ( and the connection of breast cancer with Lynch syndrome generally) due to my germline PMS2 mutation. From what I've read ( and I can't find all those studies right now on my phone), there does appear to be some correlation between MSI and ILC. Anecdotally, I have a cousin that also had lobular with this mutation. The higher mutational load caused by the defectiveMMR processmight make immunotherapy particularly useful for this type of breast carcinoma. See Aldaz CM, Chen T, Sahin A, Cunningham J and Bondy M: Comparative allelotype of in situ and invasive human breast cancer:high frequency of microsatellite instability in lobular breast cancer. Cancer Res 55: 3976-3981, 1995. I have not gotten MSI or IHC testing on my tumor yet but am considering doing so. In any event, I'm going to the Cleveland Clinic next month to discuss some of these issues with a bc researcher so will report back if I get any interesting info.

Dx 10/2015, LCIS/DCIS/ILC/IDC, Right, 1cm, Stage IB, Grade 1, 0/3 nodes, ER+/PR+, HER2- Surgery Mastectomy: Right; Reconstruction (right): Silicone implant, Tissue expander placement Hormonal Therapy Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Jul 6, 2017 03:04PM ShetlandPony wrote:

Thank you for the citation, Lab-girl. I will forward it to my onc. Can you (or anyone here) tell me what MSI testing involves? How does it relate to looking for a PDL1 mutation? I want to make sure that they check for this with my upcoming liver biopsy.

2011 Stage I ILC 1.5cm grade1 ITCs sn Lumpectomy,radiation,tamoxifen. 2014 Stage IV ILC mets breast,liver. TaxolNEAD. Ibrance+letrozole 2yrs. Fas+afinitor nope. XelodaNEAD 2yrs. Eribulin,Doxil nope. SUMMIT FaslodexHerceptinNeratinib for Her2mut NEAD
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Jul 8, 2017 11:47AM - edited Jul 8, 2017 04:56PM by Lab-girl

Hello ShetlandPony,

By no means do I have any in-depth knowledge about this topic, but what I do know is that it is possible to get lab testing for MSI and IHC testing to check for deficient MMR proteins. When I asked an expert at the research hospital I go to whether I should have this done (at the time, I was interested to know if there was a connection between my germline mutation and breast cancer), she told me to wait a few years (that was almost 2 years ago) because it wasn't clear what the best way to test for MSI in breast cancer was. Things may have changed now with the advent of Keytruda, etc. (I note that in the article I've cited below there is discussion about the type of MSI testing that was done-granted, the article relates to Pembrolizumab.). As far as the relationship of MSI to PD-L1, my understanding (which could be flawed) is that MSI results from the defective MMR process, producing tumors with lots of mutations and tumor-specific antigens and often over-expression of PD-L1, which interacts with immune cells, putting the brakes on immune response against the tumor. It looks like Merck has done research with triple negative BC and Keytruda but not sure about other MSI-H breast cancers. My guess is that MSI is not that common in normal breast cancer and is not tested routinely. Even in the Lynch syndrome world, because breast cancer is so common, germline mutations seem to be regarded as an incidental finding to the breast cancer and so not much MSI or IHC testing is done (this is anecdotal based on some forums I'm on). I think this is an area that needs more research! Will report back from Cleveland Clinic in another two weeks and let you know if I hear anything interesting.

PD-1 Blockade in Tumors with Mismatch-Repair Deficiency
http://www.nejm.org/doi/full/10.1056/NEJMoa1500596#t=article

* EDITED*: I just saw this article today which indicates that an MSI testing company is now turning toward consumer testing. http://host.madison.com/wsj/business/technology/bi...

Dx 10/2015, LCIS/DCIS/ILC/IDC, Right, 1cm, Stage IB, Grade 1, 0/3 nodes, ER+/PR+, HER2- Surgery Mastectomy: Right; Reconstruction (right): Silicone implant, Tissue expander placement Hormonal Therapy Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Sep 14, 2017 07:27AM KatjaNL wrote:

Thanks a lot for the information provided! Feeling more hopeful now living in the Netherlands and having potential access to trials - will discuss with my doctor...

Dx 7/17/2017, ILC, Left, 3cm, Stage IIA, Grade 2, 0/1 nodes, ER+/PR+, HER2- (IHC) Surgery 8/29/2017 Lumpectomy: Left; Lymph node removal: Sentinel
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Aug 12, 2018 04:30PM JohnSmith wrote:

Bumping this thread since the UK-based ROLO clinical trial for advanced lobular breast cancer announced earlier this year has just been added to the clinicaltrials.gov website, allowing for review of the inclusion/exclusion criteria.
For this trial, they are combining the ROS1 inhibitor, Crizotinib (Xalkori), with Fulvestrant (Faslodex) and will enroll
Pre-menopausal or Post-menopausal women. See Clinical Trial #5 in the original post above for more info.

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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