Palbociclib + Endocrine Therapy for Breast Cancer

(PALLAS Trial)

Recruiting at438 trial locations

Overseen by Angela DeMichele, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance Foundation Trials, LLC.

Stay on Your Current Meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing whether adding the drug palbociclib to standard hormone therapy can improve treatment for patients with a specific type of early breast cancer. The targeted patients have hormone receptor-positive and HER2-negative breast cancer. Palbociclib works by blocking proteins that help cancer cells grow, potentially making the hormone therapy more effective.

Research Team

Erica L. Mayer, MD MPH

Principal Investigator

Dana-Farber Cancer Institute

Angela DeMichele, MD

Principal Investigator

University of Pennsylvania

Evanthia Galanis, MD

Principal Investigator

Alliance Foundation Trials, LLC.

Michael Gnant, MD

Principal Investigator

ABCSG, Medical University Vienna

Eligibility Criteria

This trial is for adults over 18 with HR+/HER2- early breast cancer (Stage II or III), who have had surgery, can take oral meds, and are on or starting hormone treatment. They must not be pregnant, have normal organ function tests, no history of other cancers, and no severe illnesses that could affect participation.

Inclusion Criteria

Women who can have babies must have a negative pregnancy test within 14 days before starting the trial.

I have completed my initial cancer treatment and my side effects have mostly gone away.

I am 18 years old or older.

Exclusion Criteria

Concurrent therapy with other Investigational Products.

I am currently on hormone therapy, but topical vaginal estrogen is okay.

My breast cancer is not Stage I or IV.

Treatment Details

Interventions

• Palbociclib (CDK4/6 Inhibitor)
• Standard Adjuvant Endocrine Therapy (Endocrine Therapy)

Trial Overview The study is testing if adding palbociclib to standard endocrine therapy after breast cancer surgery improves patient outcomes compared to endocrine therapy alone. It's a Phase III trial where patients are randomly assigned to two groups in an open-label setting.

Participant Groups

Group I: Arm B Experimental Treatment 1 Intervention

Standard adjuvant endocrine therapy for a duration of at least 5 years.

Group II: Arm A Experimental Treatment 2 Interventions

Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.

Who Is Running the Clinical Trial?

Alliance Foundation Trials, LLC.

Lead Sponsor

Trials

25

Recruited

27,200+

Austrian Breast & Colorectal Cancer Study Group

Collaborator

Trials

23

Recruited

18,500+

NSABP Foundation Inc

Collaborator

Trials

89

Recruited

140,000+

Priya Rastogi

NSABP Foundation Inc

Chief Executive Officer since 2022

MD from University of Pittsburgh

Charles E. Geyer Jr.

NSABP Foundation Inc

Chief Medical Officer since 2022

MD from Texas Tech University

PrECOG, LLC.

Collaborator

Trials

19

Recruited

8,000+

Breast International Group

Collaborator

Trials

34

Recruited

53,600+

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