The Amelia-1 Clinical Trial is enrolling now for breast cancer survivors that have the PIK3CA gene mutation. 

This is the first clinical study testing the combination of evexomostat, Piqray and Faslodex together, so there could be unforeseen drug interactions or negative side effects.

Evexomostat caused serious thrombocytopenia (low platelet count) in some patients in the Phase 1 safety study. While the issue resolved by itself, it can pose risks to patients with low platelets. Other risks as noted in the Phase 1 study include fatigue, diarrhea, constipation, nausea, brittle hair and nails. 

The Patient Consent Form has more details on the risks associated with joining the study. Ask your oncologist about the potential risks before deciding to start the study.

You probably already know that some of the cancer treatments you’ve received cause problems with weight gain, rising HbA1c, cholesterol/lipids, and your overall metabolic health. 

What’s worse is that these metabolic complications - increased insulin in particular - may interfere with the effectiveness of your cancer treatment.

Diet and exercise help lower insulin, but dieting can be a challenge while undergoing cancer treatment.

We might have a solution… Evexomostat is the first experimental anti-cancer therapeutic being developed specifically for cancer patients with insulin resistance and other metabolic complications (either naturally occurring or caused by your treatment). It may also help improve the activity of your treatment and keep your cancer in check for longer. 

View our paper on the relationship between breast cancer and insulin here >>

Patients that meet the following basic criteria may be a good candidate to join the study:

⮚ HR+ (either estrogen and/or progesterone), Her2-, metastatic breast cancer

⮚ PIK3CA gene mutation

⮚ about to start 2nd line treatment (previously treated with a CDK 4/6 inhibitor such as Ibrance® in the 1st line setting)

⮚ ‘At Risk’ for hyperglycemia (meaning you have a fasting glucose level below 140 mg/dL PLUS you have either;

   o HbA1c between 5.7 and 6.4 inclusive OR

   o you are insulin resistant ( HOMA-IR score ≥1.8). This score is easy to get – it's calculated using fasting insulin and fasting glucose – your treating physician can order the test. 

Your primary care physician or oncologist can refer you to one of the clinical trial sites, or you can reach out directly to the study coordinator or Investigator listed on this site.

Here’s language you can cut/paste into an email to your physician:

Dear Dr. [    ],

I recently learned about a clinical study that I think I’d be a good fit for [https://amelia-1.com/]. If you agree, can you please make the referral to one of the study Investigators or coordinators?

The Amelia 1 Study hopes to show two things: 

1. That evexomostat can help control the Piqray-induced blood sugar (glucose) spike and the high insulin stemming from high glucose, and

2. That evexomostat can enhance the activity of Piqray and Faslodex (better response rates, longer time before progression). 

There are other, more technical objectives of the study, but these are the primary objectives.

High blood sugar is a bad actor - especially if you have cancer:

• Cancer loves sugar!  Cancer cells grow faster and reproduce more frequently than other cells, and that takes a lot of energy. Sugar is a primary source of energy for cancer cells.
• High blood sugar triggers an increase in your insulin (a protein made in your pancreas that moves sugar from your blood into your cells). BUT, insulin is also a growth hormone – not the kind of thing you want around if you have cancer!
• Studies have reported that lowering glucose and insulin helps with staying on Piqray treatment longer, and could possibly extend survival.
• Persistently high blood sugar would likely mean you’ll have to see an endocrinologist, take more medications, and possibly disrupt your cancer treatment while you get your blood sugar under control.
• Evexomostat is being tested to see if it can help control blood sugar levels while improving the efficacy of Piqray and Faslodex - a win-win.

1. Patients that have metastatic breast cancer with the PIK3CA gene mutation

2. Have already been treated with a CDK 4/6 inhibitor (palbociclib, ribociclib, etc.)

3. Are post-menopausal

4. Are at risk for alpelisib-induced high blood sugar, meaning a fasting plasma glucose <140 mg/dL AND HbA1c between 5.5 and 6.4 inclusive.

Basically, these criteria include patients with insulin resistance - of which most people are unaware.

Why join a clinical trial? You get special attention!

But first things first.  If you meet the basic criteria, and you and your oncologist think this study may be good for you, you will be given a Patient Consent Form that explains everything to you about the Study and what’s expected of you. If you agree, you sign the form, and then you’ll be screened more thoroughly.

To start, the study physician will verify you meet all the entry requirements. Assuming that goes to plan, you’ll be given a thorough physical exam along with a series of blood draws to establish a baseline, which will serve to help measure your progress on the study. Then you’ll return to the clinic according to schedule for treatments, follow-up visits, and (in the beginning) a few extra blood draws (added safety precautions).

The Sponsor has agreed to reimburse transportation expenses and daycare (on site visit days) for mothers (all within reason).

You will need to come to clinical in a ‘fasted’ state, meaning you didn’t eat or drink anything (water is OK) for at least the past 8+ hours (morning appointments make this easy!). Drinking only clear liquids (black coffee or tea with no milk/cream or sugar/sweetener) or water is fine, but NO juices or solid food of any kind until after your first blood draws – after that, it’s bon appetit!

Fasting is critical to the study, as it’s how we measure if evexomostat is working.

If your appointment is later in the day, you can come to clinic fasted, have your blood taken, then eat normally and return later for your treatment. 

For the first couple of weeks, you’ll have to come in several times so the Investigator (oncologist running the study) can be sure you are tolerating the combination well, to check for any safety issues or signals (blood chemistries) and to ask you how you’re feeling. We realize it’s a bit of a burden, but it’s only for a few extra visits, and it’s really important to monitor you for safety. To help, we can cover your parking/transportation costs (within reason, and for sites that allow for reimbursement).

After the several weeks, visits are once every 2 week, for your evexomostat treatment (30 seconds to inject), to track your progress (take blood samples, ask you about your meds and how you feel) and to check on your overall health (once monthly questionaire).

Faslodex is given at the same time as evexomostat (once every 2 weeks) for the first three doses, then once monthly. No special visits will be required for Faslodex.

Piqray is taken orally (by mouth) with food every day. You’ll start Piqray two weeks after starting evexomostat and Faslodex. It’s best to take it with lunch or your evening meal.

The Study lasts for 7 months, but you can remain on evexomostat as long as you are responding to treatment. The only requirement is that you come to the clinic fasted (no eating for at least 8 hours before arrival) once per month after the first 7 months so we can continue to monitor your progress.

You can quit any time you want, for any reason, and it won’t impact your regular treatment. However, if you quit, you will no longer receive evexomostat. You should definitely talk with your doctor before making that important decision, though.

For us to know if evexomostat is helping control patients’ blood sugar levels, we need a ‘clean’ read on glucose.  Eating and/or drinking causes an immediate increase in blood sugar (as well as an increase in insulin levels) so if you eat before we check your blood sugar, we’ll get an artificially high reading and conclude it's not working for you. 

Patients who repeatedly come to clinic not fasted will be withdrawn from the study.

There is no compensation for joining the study aside from potential clinical benefit.

However, if the site allows, the Sponsor may reimburse for transportation costs and reimburse for daycare costs (on site visit days only).

Your treating oncologist can inquire with the Investigators listed on this site, if either you or they have additional questions.

The Patient Consent Form also provides greater detail.

Depending on your location (see map ), you or your doctor can contact the Investigator or the study coordinator.