ARV-471 + Everolimus for Advanced Breast Cancer
(TACTIVE-E Trial)

Recruiting in Palo Alto (17 mi)

+17 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Arvinas Estrogen Receptor, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a new drug combination (ARV-471 and everolimus) for patients with advanced or metastatic ER+/HER2- breast cancer who have already tried other treatments. The drugs work together to slow down cancer growth by targeting estrogen receptors and blocking a growth pathway. Everolimus is used in combination with other treatments for advanced hormone-receptor-positive, HER2-negative breast cancer.

Eligibility Criteria

This trial is for postmenopausal women or those on ovarian suppression with advanced ER+/HER2- breast cancer. Participants must have tried and not responded well to certain therapies, including a CDK 4/6 inhibitor and endocrine therapy, but not treatments targeting mTOR like everolimus. They should be in good physical condition (ECOG status of 0 or 1) and agree to use a special mouthwash to prevent sores from the medication.

Inclusion Criteria

You have a disease that can be measured or evaluated according to specific guidelines.

I've had 1-3 treatments for advanced cancer, including a CDK 4/6 inhibitor and hormone therapy.

I am a woman who is either postmenopausal or taking medication to suppress my ovaries.

+3 more

Exclusion Criteria

I have not had a heart attack, severe chest pain, stroke, or significant blood clot in the last year.

I have not had serious heart rhythm problems in the last 6 months.

I have been treated with drugs targeting mTOR.

+10 more

Participant Groups

The study tests ARV-471 combined with Everolimus in patients who've had up to three lines of previous cancer treatment. It's an early-phase trial aiming to see how safe this combination is and how it affects their type of breast cancer that has spread or cannot be surgically removed.

1Treatment groups

Experimental Treatment

Group I: ARV-471 and EverolimusExperimental Treatment1 Intervention

ARV-471 oral tablets in combination with everolimus administered daily in 28 day cycles

ARV-471 is already approved in United States for the following indications:

🇺🇸 Approved in United States as Vepdegestrant for: