SANDPIPER clinical trial

I am on this clinical trial. I started on January 28th of this year. So far, no serious side effects.

Sandpiper III trial is open:

SANDPIPER: Phase III study of the PI3-kinase (PI3K) inhibitor taselisib (GDC-0032) plus fulvestrant in patients (pts) with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer (BC) enriched for pts with PIK3CA-mutant tumors.

Sub-category:
ER+

Category:
Breast Cancer—HER2/ER

Meeting:
2016 ASCO Annual Meeting

Abstract No:
TPS617

Poster Board Number:
Poster Session (Board #103a)

Citation:
J Clin Oncol 34, 2016 (suppl; abstr TPS617)

Author(s): Jose Baselga, Javier Cortes, Michele De Laurentiis, Veronique Dieras, Nadia Harbeck, Jerry Y. Hsu, Vivian Ng, Frauke Schimmoller, Timothy R. Wilson, Young-Hyuck Im, William Jacot, Ian E. Krop, Sunil Verma; Memorial Sloan Kettering Cancer Center, New York, NY; Vall d'Hebron Institute of Oncology, Barcelona, Spain; National Cancer Institute "Fondazione Pascale", Naples, Italy; Institut Curie, Paris, France; Brustzentrum der Universität München (LMU), Munich, Germany; Genentech, Inc., South San Francisco, CA; Samsung Medical Centre, Seoul, South Korea; Institut du Cancer de Montpellier, Montpellier, France; Dana-Farber Cancer Institute, Boston, MA; Tom Baker Cancer Centre, Calgary, AB, Canada

Abstract Disclosures

Abstract:

Background: PIK3CA mutations are one of the most frequent genomic alterations in BC, being present in ~40% of ER-positive, HER2-negative breast tumors. PIK3CA mutations promote growth and proliferation of tumors and can mediate resistance to endocrine therapies in BC. Taselisib is a potent and selective PI3K inhibitor that displays greater selectivity for mutant PI3Kα than wild-type PI3Kα. Taselisib has enhanced activity against PIK3CA-mutant BC cell lines, and clinical data include confirmed partial responses in pts with PIK3CA-mutant BC treated with taselisib either as a single agent or in combination with fulvestrant. SANDPIPER, a double-blind, placebo-controlled, randomized, phase III study, is designed to evaluate efficacy and safety of taselisib plus fulvestrant in postmenopausal pts with ER-positive, HER2-negative, PIK3CA-mutant locally advanced or metastatic BC.

Methods: Pts with disease recurrence or progression during or after aromatase inhibitor treatment will be randomized 2:1 to receive either taselisib (4 mg qd) or placebo in combination with fulvestrant (500 mg intramuscular on Days 1 and 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle). Randomization will be stratified by visceral disease, endocrine sensitivity, and geographical region. The study enriches for pts with PIK3CA-mutant tumors who will be randomized separately from pts with non-mutant tumors; a valid PIK3CA-mutation result in tumor tissue via central assessment is required prior to enrollment. The primary efficacy endpoint is investigator-assessed progression-free survival in pts with PIK3CA-mutant tumors. Other endpoints include overall survival, objective response rate, clinical benefit rate, duration of objective response, safety, pharmacokinetics, and patient-reported outcomes. Target enrollment is 600 pts; > 100 patients have been enrolled onto study, and enrollment is ongoing. Clinical trial information: NCT02340221

GP- I was considered it but I did not have the testing back to make sure I have the mutation so I am on just the faslodsex.

I don't of anyone on the trial but I am very interested in knowing. I heard there were troublesome SE of the trial but MO didn't elaborate. I think one was that it caused your glucose to go crazy.

Keep us posted Carol

Thanks for chiming in. One of the side effects is high blood sugar, so we'll be sure to keep a close eye on that. According to our onc, the trial drug has been pretty well tolerated. LovesMaltese, has the Faslodex been effective for you? It's nerve-wracking to have the possibility of only getting a placebo, so I hope the Faslodex will be effective at least on its own.

Carol,

Great idea. I had the same thought about high blood sugar being counterproductive, so if that's an issue we will be extra careful with diet and talk to the onc about diabetes medication.

Not sure why my diagnostic/treatment info isn't showing up here. My wife has stage IV IDC with mets to liver and bone. She's ER+/PR-/HER2- and her genetic testing shows that she has the PIK3CA mutation.

Gina

Hi Gina,

I am also very interested in this trial, because the PI3K inhibitor it tests (Taselisib) is looking like it is significantly more effective than two other new ones in the pipeline.

What is the exact drug or treatment history your wife has had thus far, since detecting the metastasis? I assume that you would want to not have been treated with the aromasin/affinitor combo previously? Was the biopsy that showed the mutation for the original cancer or was it done after resistance to a previous drug?

Also, regarding the sugar, my understanding is that breast cancer is not as sensitive as some other cancers, like pancreatic, so may not be assisted as much by metformin etc...

Any information you can get from the oncologist or nurses about the side effects and status of the trial is very much appreciated! Good luck!!

Michelle- Congratulations on your upcoming five year anniversary- fantastic!!! It is disappointing, but not surprising, to hear that the side effects of Taselisib are so similar to Affinitor, dang! I always get excited about new treatments, until hearing about the side effects. Good for you for trying several different trials, have you considered any combination trial that include immunotherapy? I think there is a femara-Keytruda one, and Atezo looks like it may have exceptionally good activity in combination with several different drugs. Have you had Ibrance? I am taking Ibrance-Femara with no real side effects other than hair loss, and will have a scan Monday to see if its still working ..

GP103 - I am very interested in your wife's experience in this trial, please let us know how it goes. Let us know the selection process, the side effects, the outcomes, everything. We're all ears.

You have to edit your profile AND make it public for the diagnosis and treatment history to appear in your signature. Two steps. Poke around in settings a bit. It's super helpful that everyone has this information updated in their signature. It's one of the things that makes BCO much more useful than other sites, IMO.

I am on metformin. Prescribed by a complementary oncologist (CO) to support my treatment. I believe it facilitates the uptake of sugar by normal cells, which keeps sugar from hanging out in the blood. This deprives the cancer of sugar. Or that is my best understanding of the Theory of Metformin. I've always had low blood sugar. I've never had diabetes. I'd like to lose 5-7 lbs, but I am not overweight by any measure. It seems like it could help with Taselisib side effects.

Cure-ious - that is so interesting that breast cancer is not as sensitive to sugar. My CO wants me on it so I do it, but I haven't really dug into it much.

>Z<

Cure-ious - Thanks. You remind me that Metformin directly effects the cancer cell growth cycle and not just blood sugar levels in a dish, so that's another reason to take metformin.

Reading your brief discussion of night time fasting, my mind and my body said yes, yes, yes. I'd like to learn more if you have any references or additional information. What time of day do you stop eating?

>Z<

Also if I got too hungry at night and was tempted to eat, I just went to sleep. In my house we stay up too late anyway. This procedure links the food cycle with the circadian rhythm, so its reinforcing to both pathways..

Because of my rare genetic condition that links cancer and metabolism, I've paid attention to CR (caloric restriction) and night fasting research and practices for years.

My long time practice of not eating between 5 PM and 7 AM has been broken because of my extreme medical condition at end-of-life -–cachexia, malnutrition and dehydration.

The medical research hasn't been proven by large double-blind, placebo controlled clinical trials, but there is good evidence that caloric restriction and night fasting are helpful in cancer and many health challenges.

This is, of course, best combined with eating what is for you a healthy diet. My general guideline remains that of Michael Pollan - eat food, not too much, mostly plants. But my body craves protein and energy-dense food, so I eat more animal protein than ever before.

Listening to my body's wisdom seems the best path to success.

Best healing wishes, Stephanie

Hi everyone,

I finally figured out how to make my diagnosis/treatment info appear, so that should answer a few questions. After her primary treatment for stage III IDC, my wife was put on letrozole for maintenance. Unfortunately that was completely ineffective because she developed liver mets within a few months. The genetic testing that revealed a PIK3CA mutation was done after my wife's liver biopsy. When she was diagnosed as stage IV she was put on Xeloda immediately, and while it appears to have worked somewhat, the scan two weeks ago showed mild progression and new bone mets. We are at Sloan-Kettering, which is one of the trial sites for SANDPIPER, and our onc suggested the trial as a first try because of the PIK3CA mutation. My wife will be meeting with the onc again next week to go over all the details for the trial and hopefully get started on the new drugs.

From what I understand at this point, the selection process is pretty straightforward. I believe most of you would qualify. The trial is still open and there are many sites throughout the US. When I get the detailed info on side effects I will keep posting here.

Good advice on Metformin - I've heard about it's helpfulness in decreasing blood sugar in order to deprive the cancer cells, but it's interesting that it's also effective via another mechanism. I'll be sure to ask about it.

Thank you gp193. Extremely interested in your experience with the trial.

>Z<