ARV-471 + Palbociclib for Breast Cancer
(mBC Trial)

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Arvinas Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called ARV-471 alone and with palbociclib in patients with advanced breast cancer who have tried other treatments. ARV-471 breaks down proteins that help cancer grow, and palbociclib stops cancer cells from multiplying.

Eligibility Criteria

This trial is for postmenopausal women with ER+/HER2- advanced breast cancer who've had prior hormonal therapy and chemotherapy. They must have measurable disease, be over 18, willing to undergo biopsies, and can't have more than two prior chemo regimens for advanced disease or symptomatic brain metastases.

Inclusion Criteria

I have been treated with hormone therapy for my advanced cancer for at least 6 months.

My cancer's size or presence can be measured by scans done within the last 28 days.

I have had 2 or fewer chemotherapy treatments for my advanced disease.

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Exclusion Criteria

I haven't had radiation that affected more than 25% of my bone marrow or any in the last 4 weeks, except for pain relief.

I haven't taken any cancer treatment or experimental drugs in the last 14 days.

I have brain metastases but am stable and off high-dose steroids for 4 weeks.

Treatment Details

Interventions

ARV-471 (Hormone Therapy)
Palbociclib (IBRANCE®) (CDK4/6 Inhibitor)

Trial OverviewThe study tests ARV-471's safety and effectiveness alone and with palbociclib in treating breast cancer that has spread or cannot be cured by standard treatments. It involves increasing doses to find the right amount and then expanding the group to further assess its effects.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: ARV-471 and palbociclib (IBRANCE®)Experimental Treatment1 Intervention

Part C: Daily oral dosages of ARV-471 for 28 days in combination with palbociclib (IBRANCE®) for 21 days.

Group II: ARV-471Experimental Treatment1 Intervention

Parts A and B: ARV-471 administered QD or BID for 28 day cycles.

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

🇺🇸 Approved in United States as Vepdegestrant for: