Lasofoxifene + Abemaciclib for Breast Cancer

(ELAINEII Trial)

Recruiting at 15 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Sermonix Pharmaceuticals Inc.

Must be taking: Ovarian suppression

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers

Disqualifiers: Lung carcinomatosis, Visceral crisis, RB1 mutations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

29 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an open-label, multicenter, single-arm safety study evaluating the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.

Eligibility Criteria

This trial is for pre- and postmenopausal women with advanced or metastatic ER+/HER2- breast cancer that worsened after hormonal therapy. They must have specific ESR1 mutations, received one chemo regimen, and meet certain health criteria. Exclusions include significant other illnesses, recent serious blood clots, active infections requiring IV antibiotics, and certain drug interactions.

Inclusion Criteria

I am fully active or can carry out light work.

I am either before or after menopause.

My cancer has specific ESR1 mutations.

Exclusion Criteria

You have a history of long QT syndrome, or your QT interval is longer than 480 milliseconds.

If you are a woman who can still have children, you are pregnant.

I have hepatitis C with a measurable viral load.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lasofoxifene and abemaciclib combination therapy for advanced or metastatic ER+/HER2- breast cancer

Up to 24 months

Visits at regular intervals as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Abemaciclib
• Lasofoxifene

Trial Overview The study tests a combination of lasofoxifene and abemaciclib in women whose breast cancer has progressed despite treatment. It's an open-label trial where all participants receive the drugs to assess safety and tolerability.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Women who have locally advanced or metastatic ER+/HER2- breast cancer and disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation

Abemaciclib is already approved in United States, European Union for the following indications:

Approved in United States as Verzenio for:

• Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
• HR+, HER2- node-positive early breast cancer

Approved in European Union as Verzenio for:

• HR+, HER2- advanced or metastatic breast cancer
• HR+, HER2- node-positive early breast cancer

Who Is Running the Clinical Trial?

Sermonix Pharmaceuticals Inc.

Lead Sponsor

Trials

3

Recruited

630+