Stage IV TNBC clinical trial in USA

Hi all,

I was diagnosed with TNBC last year…a change from my original pathology. I was stage 1 in 2006 with a breast lump (lumpectomy and radiation).
In 2008 I became stage iv with mets to my sacrum. Chemo and Femara and removal of ovaries.
A few more progressions and medicines (best was 4 yrs on Faslodex).

As stage 4 TN I was put on oral chemo May 2016. Great initial response after 3-4 months. Hand-foot syndrome side effects then sadly more progession. Stopped working Oct 2016. Stopped chemo Jan 2017.

CLINICAL TRIAL started Feb 22 2017. I could walk on my own but was in rough shape. Cellulitis. Lymphodema in left leg. Mets in sacrum and many places in spine, sternum, hips, left adrenal gland and pelvic soft tissue. Hydronephrosis to left kidney with a stent in place from bladder to kidney. On pain meds for a year approx (3 kids born at home with no drugs previously…so for me to take a pain pill esp prescription means I am hurting).

Fast forward to week 5 of trial. I am sent for a voluntary routine biopsy of my left adrenal gland that was biopsied in late Jan and had a 6cm tumor.

I was on the table all ready for my new biopsy. Had on the gown,hat, IV in place and they were just about to start the meds. One arm was even taped to table for extra support because they didnt like how it was positioned or wanting to rotate.
They did another CT and put a sticky grid on my back to mark/guide places the needle would go for biopsy.
Suddenly there is rechecking of my ID band, asking me to repeat my name and birth date etc.
The doctor comes in to tell me no biopsy of this gland. Cancelling because they cannot find a tumor in my adrenal gland! They were confirming correct patient was on the table.
Much celebrating. Something is working!
My full 6 week scans still show existence of mets in various places but adrenal gland back to almost normal size and previously baseball size tumor abutting my uterus was cut nearly in half.
12 weeks in my bone mets are still same size but l am lighting up less on imaging. Slight reduction in pelvic tumor compared to 6 weeks. Other lymph mets resolved or shrinking.
Have I plateaued? Not for certain. I responded early unexpectedly and it doesnt mean I wont have further response later. I have no new growth or disease progression. Also significant…I haven’t taken any pain pills in a month! Something good is going on in my body…and I hope it continues and the cancer doesnt figure out too much and mutate again.

I am patient #1 on Phase 2 of this trial so there are unknowns clearly. But all involved are excited by my initial response. They are still recruiting patients. Its an open trial with 2 drugs and NO placebo or randomization. Brand names are Keytruda and Imprime PGG (immunotherapy). Offered in several locations around the USA. I go to Santa Monica CA (near Los Angeles).

My experience may not be the same as yours. I have hope again…for how long no one knows for sure. Without trial success I have been told my oncologist sees a 2-7 yr survival rate among her stage iv TNBC patients. I do have a history of being responsive to treatment whereas with some patients she is changing their meds with every scan due to progession.

Here is a link to the trial info in case anyone is interested:

Thank you for posting in such detail. I am in London with TN grade 3 type 3 diagnosed Dec 16. Had chemo which shrunk it then had Taxol when grew so surgery two weeks ago. Now suggesting oral chemo called capeticibane (followed by rad) and wondered if this is what you had that helped you for 3-4 months? They are suggesting I take it for 6 rounds so 4 months. I am concerned about monitoring and how closely they can tell if it is working as continued on Taxol oblivious until scan at 8 weeks so obviously anxious to check progress. Can you let me know how they monitored you to know if working?
Such a Great story about operating theatre and adrenal glands!! Way to go!! ??

I was put on the same oral chemo in May 2016 and took it until Jan 2017. I has PET scan in late Aug 2016 and it showed significant improvement in my numerous metastatic spots and my tumor markers took a steady decrease as well. I did develop hand foot syndrome and we reduced my dosage in Nov I believe but in fact my tumor markers were already starting to creep back up with October’s blood draw. However note I was stage 4. You are stage 3. It may work better for you or be worth a try.

Hi Suz777, I thrilled to read of your success on the trial of Keytruda. I am from Australia and we do not have easy access to the drug, but as I hit the final wall a month ago my Oncologist told me of this drug. the cost is horendous but my kids have told me I have to give it a go as they want me around for the grandchildren!! I too wish to see them grow up. :slight_smile:

I’ve only had 1 session and I can’t believe the effect it has had on my old body! I sleep up to 11-12 hrs, my brain has the worst chemo fog since my 1st chemo in August 2014. My brain and my mouth do not correspond and cause me much distress. I’m just hoping that the drug is working so hard that my body just has to go into ‘sleep’ mode so the drug can do its thing!

As I’m not on a trial I have to wait for 4 sessions before my next ct scan. I was on a trial last year for CDX-011 (as US trial of a targeted drug for TNBC, after 8 mths the cancer spread to my lungs) and was used to frequent scans but I will have to be patient now!

Thanks for any comments you can give me.


My intial treatments left me highly fatigued…I was also taking a second immunotherapy agent with it (Imprime PGG) so its hard to say which caused fatigue…one or the combination. But after a couple of treatments or so I got more used to it and did not take a couple days to recover any longer. Its a battle going on in your body and your immune system may be working/reacting in ways it never has before…can be fatiguing. I had some ever so slight chest tightening/almost wheezing that dissipated after 2 rounds.

I would make sure your doctor knows. Maybe they can give you some premeds prior to treatment if need be…like Benadryl or some such thing.

I wish you well and hope you can continue treatment with successful results. It has been a lifesaver for me.


Thanks Suzie. I appreciate your reply and will be keeping notes for my oncologist. Keep well. Ricki x

Great story, thank you for posting.  I have worked in clinical trials for most of my career, but the importance of them really hit hard when I was diagnosed in 2014 with TNBC.  Being the patient makes me more passionate about inspiring my colleagues to continue to fight to find the killer-blow to this enemy.