Targeted Therapy for Metastatic Breast Cancer

(PATINA Trial)

Recruiting in Palo Alto (17 mi)

+118 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance Foundation Trials, LLC.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.

Eligibility Criteria

This trial is for adults over 18 with hormone receptor-positive, HER2+ metastatic breast cancer that can't be removed by surgery or treated with radiation. Participants must have confirmed invasive breast cancer and agree to provide tumor tissue samples. It's not suitable for those who don't meet these specific cancer criteria.

Inclusion Criteria

My breast cancer is confirmed to be HER2+, ER+, or PR+ and metastatic.

My breast cancer cannot be removed by surgery or cured with radiation, and it may have spread.

I agree to provide a tissue sample from my cancer for testing.

Participant Groups

The study tests if adding palbociclib to anti-HER2 therapy and endocrine therapy (like Anastrozole, Fulvestrant) improves outcomes in patients compared to just anti-HER2 therapy plus endocrine treatment alone.

Group I: Arm A Experimental Treatment 7 Interventions

Palbociclib 125 mg daily + AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt) until confirmed disease progression

Group II: Arm B Active Control 5 Interventions

AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant) until confirmed disease progression

Palbociclib is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Ibrance for:

• HR-positive, HER2-negative advanced or metastatic breast cancer

🇪🇺 Approved in European Union as Ibrance for:

• HR-positive, HER2-negative locally advanced or metastatic breast cancer

🇨🇦 Approved in Canada as Ibrance for:

• HR-positive, HER2-negative advanced or metastatic breast cancer

🇯🇵 Approved in Japan as Ibrance for:

• HR-positive, HER2-negative advanced or recurrent breast cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Maryland - Greenebaum Comprehensive Cancer Center Baltimore, MD

Dana-Farber Cancer Institute Boston, MA

Vanderbilt University Medical Center Nashville, TN

Lexington Medical Center West Columbia, SC

More Trial Locations

Who Is Running the Clinical Trial?

Alliance Foundation Trials, LLC. Lead Sponsor

SOLTI Breast Cancer Research Group Collaborator

PrECOG, LLC. Collaborator

UNICANCER Collaborator

Syneos Health Collaborator

Breast Cancer Trials, Australia and New Zealand Collaborator

Pfizer Industry Sponsor

German Breast Group Collaborator

Fondazione Michelangelo Collaborator

References