ARV-471 + Palbociclib for Breast Cancer

(mBC Trial)

Recruiting at 18 trial locations

Overseen By Arvinas Estrogen Receptor, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Arvinas Inc.

Must be taking: CDK4/6 inhibitors

Must not be taking: High-dose corticosteroids

Disqualifiers: Symptomatic brain metastases, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: up to 2 years

217 Participants Needed

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ARV-471 alone or in combination with palbociclib in 28-day cycles to assess safety, tolerability, and anti-tumor activity

up to 2 years

Monthly visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• ARV-471
• Palbociclib (IBRANCE®)

Trial Overview The 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

Group I: ARV-471 and palbociclib (IBRANCE®) Experimental Treatment 1 Intervention

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

Group II: ARV-471 Experimental Treatment 1 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:

• None approved; under investigation for ER+/HER2- metastatic breast cancer

Who Is Running the Clinical Trial?

Arvinas Inc.

Lead Sponsor

Trials

4

Recruited

730+

Arvinas Estrogen Receptor, Inc.

Lead Sponsor

Trials

19

Recruited

2,400+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University